[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jaeb Center for Health Research\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":550},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,40,70,96,125,152,175,198,223,246,272,290,314,355,385,408,434,460,487,516],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100484566","universal-rare-gene-study-a-registry-and-natural-history-study-of-retinal-dystrophies-associated-with-rare-disease-causing-genetic-variants-100484566",false,"NCT05589714","Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated With Rare Disease-Causing Genetic Variants","Uni-Rare","Inclusion Criteria: Participants must meet all the following inclusion criteria at the Registry\u002FScreening Visit to be eligible to enroll into the genetic screening phase:\n\n1. Willing to participate in the study and able to communicate consent during the consent process\n2. Willing and able to complete all applicable Registry\u002FScreening Visit assessments\n3. Age ≥ 4 years\n4. Must have a single gene on the RD Rare Gene List which meets one of the Genetic Screening Criteria below based on a genetic report\\* from a clinically certified lab (or from a research lab which has been approved by the study Genetics Committee):\n\nInheritance Pattern is Recessive and has at least 2 disease-causing variants which are homozygous or heterozygous in trans\n\nOR\n\nInheritance Pattern is Recessive and has 2 disease-causing variants with unknown phase and meets all the following additional informatic criteria that is consistent with likely segregation in trans:\n\n1. Investigator confirms genotype and phenotype are consistent with autosomal recessive inheritance\n2. The 2 disease-causing variants have not been reported in cis in variant databases\n3. No additional potentially pathogenic variants were found on the gene (and the sequencing data for the gene were sufficiently robust to detect any additional potentially pathogenic variants)\n4. No potentially pathogenic variants were found in other common, likely candidate genes for the proposed condition\n\nOR\n\nInheritance Pattern is Dominant, X-linked, or Mitochondrial and has at least 1 disease-causing variant\n\nBoth eyes must meet the following criteria at the Registry\u002FScreening Visit to enroll into the genetic screening phase:\n\n1. Both eyes must have a clinical diagnosis of retinal dystrophy\n2. Both eyes must permit good quality photographic imaging (e.g., but not limited to, clear ocular media, adequate pupil dilation, stable fixation)\n\nExclusion Criteria:\n\nParticipants must not meet any of the following exclusion criteria at the Registry\u002FScreening Visit to be eligible to enroll into the genetic screening phase:\n\n1\\. History of more than 1 year of cumulative treatment, at any time, with an agent associated with pigmentary retinopathy including amiodarone, chloroquine, deferoxamine, hydroxychloroquine, pentosan polysulfate, tamoxifen, and deferoxamine Note: Since this is an observational study, pregnant women will not be specifically excluded from participation. However, minors that are pregnant shall be precluded from participation until they become the age of majority.\n\nOcular Exclusion Criteria:\n\nIf either eye has any of the following ocular exclusion criteria at the Registry\u002FScreening Visit, then the participant is not eligible to enroll into the genetic screening phase:\n\n1. Current vitreous hemorrhage\n2. Current complications of pathological myopia (for example, but not limited to, myopic maculopathy including atrophy, scar, choroidal neovascularization, schisis) that could inhibit ability to obtain good quality photographic imaging\n3. History of intraocular surgery (for example, but not limited to, cataract surgery, vitrectomy, penetrating keratoplasty, or LASIK) within 3 months of Registry\u002FScreening Visit\n4. Current or any history of confirmed diagnosis of glaucoma (for example, but not limited to, glaucomatous VF changes or nerve changes, or history of glaucoma filtering surgery)\n5. Current or any history of retinal vascular occlusion or proliferative diabetic retinopathy\n6. History or current evidence of ocular disease that, in the opinion of the Investigator, may confound assessment of visual function (for example, but not limited to, tractional or rhegmatogenous retinal detachment, any vitreoretinal surgery, retinal vascular occlusion, proliferative diabetic retinopathy)\n7. The following medications and treatments are prohibited as they can affect progression of retinitis pigmentosa (RP). The participant must not have received the following treatments:\n\n   Any use of ocular stem cell or gene therapy Any treatment with ocriplasmin Treatment with Ozurdex (dexamethasone), Iluvien, or Yutiq (fluocinolone acetonide) intravitreal implant\n8. The following medications and treatments are excluded within the specified timeframe:\n\nTreatment with an ophthalmic oligonucleotide within the last 9 months (last treatment date is less than 9 months prior to Registry\u002FScreening Visit date)\n\nTreatment with any other product within five times the expected half-life of the product (time from last treatment date to Registry\u002FScreening Visit date is at least 5 times the half-life of the given product)","ALL","4 Years",{"count":19,"type":20},1500,"ESTIMATED","OBSERVATIONAL","This is an international, multicenter study with two components:\n\nRegistry\n\n* A standardized genetic screening and a prospective, standardized, cross-sectional clinical data collection\n* Enrollment is open to all genes on the RD Rare Gene List\n\nNatural History Study\n\n* A prospective, standardized, longitudinal Natural History Study\n* Enrollment opens gene-by-gene, based on funding and within-gene Registry enrollment The study objectives are as follows.\n\nRegistry Objectives\n\n1. Genotype Characterization\n2. Cross-Sectional Phenotype Characterization (within gene)\n3. Establish a Link to My Retina Tracker Registry (MRTR)\n4. Ancillary Exploratory Studies - Pooling of Genes\n\nNatural History Study Objectives\n\n1. Natural History (within gene)\n2. Structure-Function Relationship (within gene)\n3. Risk Factors for Progression (within gene)\n4. Ancillary Exploratory Studies - Pooling of Genes",[24,25],"Inherited Retinal Degeneration","Retinitis Pigmentosa",[24],"RECRUITING","2026-06-24",{"date":30,"type":31},"2026-06-26","ACTUAL",{"date":33,"type":31},"2023-05-11",{"date":35,"type":20},"2030-12-15",{"name":37,"class":38},"Jaeb Center for Health Research","OTHER",36,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100600315","phase-3-a-rct-of-spectacles-with-aspherical-lenslets-or-005-atropine-for-myopia-control-100600315","NCT07095894","A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control","A Randomized Placebo-controlled Trial of Spectacles With Highly Aspherical Lenslet Target (H.A.L.T.) MAX Technology or 0.05% Atropine to Slow Progression of Myopia in Children","Inclusion Criteria:\n\n1. Age 5 years to \\\u003C12 years at time of enrollment. Children within 4 weeks of their 12th birthday are not eligible.\n2. Refractive error meeting the following by cycloplegic autorefraction:\n\n   * Myopia of 0.75D to 6.00D SER and at least 0.75D in both principal meridians of each eye\n   * Astigmatism \\\u003C2.50D both eyes\n   * Anisometropia \\\u003C1.50D SER\n3. Investigator has confirmed the following regarding best-corrected distance visual acuity (VA) in habitual spectacles or trial frames using the investigator's preferred VA testing method:\n\n   * VA is age normal in both eyes1,2\n   * 5-6 years: approximately 20\u002F32 or better, ≤ 0.24 logMAR, ≥ 73 letters\n   * 7-12 years: approximately 20\u002F25 or better, ≤ 0.14 logMAR, ≥ 78 letters\n   * Interocular difference ≤2 logMAR lines (0.2 logMAR) or ≤ 10 letters\n4. Wearing spectacles by parent report ≥90% of waking hours ≥30 days duration before enrollment. For children who meet all other inclusion criteria but whose single-vision spectacles are broken or lost within the last 90 days, enrollment can proceed as long as the child was wearing their single-vision spectacles ≥90% of waking hours ≥30 days before the spectacles were broken or lost.\n5. Gestational age ≥ 32 weeks.\n6. Birth weight \\>1500 g.\n7. Parent(s) and assenting child understand the study procedures and are willing to accept randomization to atropine 0.05%, HAL lenses, atropine combined with HAL lenses, or placebo (i.e., neither active treatment).\n8. Parent is willing to participate in a 2- to 4-week run-in phase using nightly artificial tear eyedrops in both eyes.\n9. Family can return in 2 to 4 weeks for possible randomization.\n10. Child is willing to refrain from contact lenses for the duration of the study.\n11. Parent has a phone (or access to a phone) and is willing to be contacted by the clinical site staff.\n12. Relocation outside of the area of an active PEDIG site within the next 32 months is not anticipated.\n\nExclusion Criteria:\n\n1. Current or previous pharmacologic or light therapy used for myopia treatment.\n2. Current or prior contact lens wear more than 7 days in the past 12 months\n3. Current or previous use of bifocals, progressive-addition lenses, multi-focal contact lenses, or focus- or contrast-modifying spectacle lenses.\n4. Current or previous use of orthokeratology, rigid gas permeable, or other contact lenses used to slow myopia progression.\n5. Current or previous myopia control treatment or other uses of atropine, pirenzepine or other anti-muscarinic agents.\n6. Known atropine allergy\n7. Known allergy to shellfish\n8. Abnormality of the cornea, lens, central retina, iris, or ciliary body\n9. Current constant or intermittent strabismus (phorias are acceptable)\n10. Verified history of amblyopia or nystagmus.\n11. Prior strabismus, intraocular, or refractive surgery\n12. Down syndrome or cerebral palsy\n13. Diseases known to affect accommodation, vergence, or ocular motility (e.g., multiple sclerosis, Graves' disease, myasthenia gravis, diabetes mellitus)\n14. Any condition that, in the judgment of the investigator, could influence refractive error development.\n15. Existing conditions in the opinion of the investigator that may affect the long-term health of the eye or require regular pharmacologic treatment that may adversely interact with study medication (e.g., JIA, glaucoma, pre-diabetes).\n16. Inability to comprehend and\u002For perform any study-related procedures.\n17. Individuals who are pregnant, lactating, or intending to become pregnant within the next 30 months.\n\n    a. A negative urine pregnancy test at randomization and the 6-, 12-, 18-, and 24-month follow-up visits will be required for individuals who have experienced menarche (at least one menstrual cycle).\n18. Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is investigative site personnel directly affiliated with this study or who is an employee of the Jaeb Center for Health Research.\n19. Sibling of, or living in the same household as, another child who is concurrently enrolled in the study.","5 Years","11 Years",{"count":50,"type":20},348,"INTERVENTIONAL",[53],"PHASE3","To date, randomized trials of low-concentration atropine eyedrops and specially designed spectacle lenses to slow the progression of myopia are limited in number and results are inconsistent in non-Asian children.\n\nAlthough results of some recent randomized clinical trials outside the US are promising, additional studies in children are needed to test the safety and efficacy of low-concentration atropine and specially designed spectacle lenses as treatments to slow the progression of myopia during the peak years for eye growth.\n\nAfter a run-in phase to demonstrate adherence with nightly eyedrops (artificial tears) and spectacle correction, children 5 to \\\u003C12 years old with myopia of 0.75D to 6.00D cycloplegic spherical equivalent refractive error (SER) and at least 0.75D myopia in both principal meridians of each eye will be randomized in a 2x2 factorial design to treatment with 1) nightly 0.05% atropine or placebo eyedrops, and 2) spectacles with highly aspherical lenslet target (H.A.L.T.) MAX technology or single vision spectacles, and followed every six months for 24 months. Change in axial length over 24 months and change in SER over 24 months are the primary and secondary outcomes, respectively.\n\nAll children will return for a visit at 30 months (after 6 months of no treatment other than single-vision spectacles alone between 24 and 30 months).\n\nThe study is funded by the National Eye Institute, part of the NIH, and coordinated by the Jaeb Center for Health Research on behalf of PEDIG. Essilor International, a subsidiary of EssilorLuxottica, the manufacturer of Spectacle lenses with H.A.L.T.\\* MAX technology, is providing the eyeglasses and financial support for the study. The 0.05% atropine eye drops used in the study are manufactured by Imprimis Rx, a subsidiary of Harrow, Inc.",[56],"Myopia",[58,59,60,61],"myopia","spectacles","atropine","pediatric","2026-06-23",{"date":30,"type":31},{"date":65,"type":31},"2026-06-01",{"date":67,"type":20},"2029-06-01",{"name":37,"class":38},17,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":51,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100550638","phase-3-bionic-pancreas-in-cfrd-100550638","NCT06449677","Bionic Pancreas in CFRD","A Randomized Trial of the Insulin-only Bionic Pancreas in Cystic Fibrosis Related Diabetes","Inclusion\n\n1. Age ≥ 14 years old at time of signing informed consent\n2. Able to provide informed consent (and assent for participants \\\u003C18 years old)\n3. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:\n\n   * Sweat chloride equal to or greater than 60 mmol\u002Fliter by quantitative pilocarpine iontophoresis test (QPIT) (when not taking a cystic fibrosis transmembrane conductance regulator (CFTR) modulator)\n   * Two well-characterized mutations in the CFTR gene\n4. Clinical diagnosis of CFRD, defined as a person with CF and diabetes mellitus, treated with insulin for ≥3 months prior to screening\n5. Using the same insulin regimen for ≥1 month prior to screening and collection of baseline CGM data, with no plans to change regimen during the study: either multiple daily injections of insulin (MDI), basal-only without bolus insulin, an insulin pump without automation, or an automated insulin delivery (AID) system other than the BP (which is an exclusion)\n6. Total daily insulin dose must be ≥0.1 units\u002Fkg\n7. Able to speak and read English sufficient to understand the pump user interface and provide written materials for safe operation of the BP\n\n   • For pediatric participants, this applies to both the participant and caregiver\n8. For participants \\\u003C18 years old, living with one or more parent\u002Flegal guardian knowledgeable about emergency procedures for severe hypoglycemia. A designated care partner must be willing to be linked to the participant's Dexcom Follow application with location sharing on.\n9. For participants \\>18 years old who live alone, participant has a relative or acquaintance who lives within 30 minutes of participant and is willing to be contacted to check on participant if study staff feel that participant may be experiencing a medical emergency and cannot be reached. A designated care partner must be willing to be linked to the participant's Dexcom Follow application with location sharing on.\n10. No use of a non-insulin glucose-lowering medication, except metformin, that is not approved for use in T1D within 3 months prior to signing informed consent and willing to not use any such medications during the course of the trial. Note: such drugs cannot be used even if prescribed for weight loss rather than glucose-lowering.\n11. If not currently using a rapid-acting insulin that is approved for use in the iLet pump, willing and able to switch to an approved insulin when using the BP.\n12. Participant has commercial glucagon available for treatment of severe hypoglycemia or will obtain it prior to randomization\n13. Willing to authorize the study team to contact the participant's primary physician to inform them about their participation in this study.\n14. Enrolled in the Cystic Fibrosis Foundation Patient Registry (participants may enroll in the Registry at the time of enrollment if not already enrolled).\n15. No plans for trips of more than 14 consecutive days outside the United States during the period of study participation\n16. Investigator believes that the participant can safely use the iLet and will follow the protocol • The investigator will take into account the participant's HbA1c level (there is no upper limit for eligibility), compliance with current diabetes management, prior acute diabetic complications, cognitive ability, and general medical condition. For this reason, there is no upper limit on HbA1c specified for eligibility.\n\nExclusion\n\n1. Current use of the BP or an AID system not FDA approved for T1D\n2. Known hemoglobinopathy (sickle cell trait is not an exclusion)\n3. Current participation in another diabetes-related interventional trial\n4. Established history of allergy or severe reaction to adhesive or tape that must be used in the study\n5. Pregnant (positive urine hCG), breast feeding, plan to become pregnant in the next 7 months, or sexually active and can become pregnant but not using contraception\n6. Current use of hydroxyurea or unable to avoid hydroxyurea use during the study (interferes with accuracy of Dexcom sensor)\n7. Have started or stopped a CFTR modulator in the 4 weeks prior to screening.\n\n   • Modifications of the dosing of a CFTR modulator is acceptable\n8. Anticipated lung or liver transplant (on transplant list)\n9. Lung or liver transplant within one year prior to screening. If they have had a transplant more than a year ago, but they:\n\n   * Have had a rejection episode occur in prior 8 weeks, individual is excluded.\n   * Their doses of corticosteroids and\u002For calcineurin inhibitors have not been stable for one month prior to enrollment and\u002For is expected to change significantly over the course of the study, individual is excluded.\n10. Acute pulmonary exacerbation or hospitalization within the 4 weeks prior to screening or treatment with IV antibiotics in the 4 weeks prior to screening\n11. History of a complete pancreatectomy\n12. Currently using enteral tube feedings for nutritional support\n13. Presence of a medical condition or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant. Conditions to be considered by the investigator may include the following:\n\n    * Alcohol or drug abuse\n    * Use of prescription drugs that may dull the sensorium, or hinder decision-making during the period of participation in the study such has opioids or short-acting benzodiazepines\n    * Coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise (e.g., climbing a flight of stairs) despite medical management; or within the last 12 months before screening: a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting\n    * Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV\n    * History of TIA or stroke in the last 12 months\n    * Severe liver disease such as end-stage cirrhosis\n    * Renal failure requiring dialysis or known eGFR \\\u003C30\n    * Untreated or inadequately treated mental illness\n    * History of untreated or inadequately treated eating disorder within the last 2 years, such as anorexia, bulimia, or diabulimia or omission of insulin to manipulate weight\n    * History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment\n14. Employed by, or having immediate family members employed by Beta Bionics, or being directly involved in conducting the clinical trial, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.","14 Years",{"count":79,"type":20},150,[53],"This multi-center randomized controlled trial (RCT) will compare efficacy and safety endpoints using the insulin-only configuration of the iLet Bionic Pancreas System (BP) versus a control group using their usual care insulin delivery method and continuous glucose monitoring (CGM) during a 13-week study period in individuals ≥14 years old with cystic fibrosis-related diabetes (CFRD). After 13 weeks, participants will continue in a 13-week Extension Phase in which the BP group will continue to use the BP system and the Usual Care group will initiate use of the BP system.",[83],"Cystic Fibrosis-related Diabetes",[85,86,87,88],"Cystic fibrosis-related diabetes (CFRD)","iLet bionic pancreas","Automated insulin delivery","Continuous glucose monitoring",{"date":28,"type":31},{"date":91,"type":31},"2024-09-24",{"date":93,"type":20},"2027-03-30",{"name":37,"class":38},16,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":51,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100576860","phase-3-faricimab--prp-vs-vitrectomy--endolaser-for-treatment-of-pdr-100576860","NCT06790784","Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR","A Randomized Clinical Trial Evaluating Combination Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of Proliferative Diabetic Retinopathy","AP","Inclusion Criteria:\n\nIndividual:\n\n* ≥ 18 years old\n* Diagnosis of diabetes mellitus (type 1 or type 2)\n\nStudy Eye:(A participant can have one or two study eyes if both eyes are eligible at screening.)\n\n* Presence of PDR requiring treatment, defined as moderate PDR or worse on global grading of ultrawide field fundus photos or NV meeting criteria for moderate PDR or worse on global grading of ultrawide field FA, confirmed by a central reading center\n* Best corrected visual acuity ≥49 letters (20\u002F100 Snellen equivalent or better)\n\nExclusion Criteria:\n\n* Individual:\n\n  * Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.\n  * Blood pressure \\> 160\u002F100 (systolic above 160 or diastolic above 100).\n\n    o If blood pressure is brought below 160\u002F100 by anti-hypertensive treatment, individual can become eligible.\n  * For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.\n\n    * Women of childbearing potential will be required to have pregnancy testing or use an acceptable method of pregnancy prevention. Women who are potential study participants should be questioned about the potential for pregnancy at baseline and prior to each injection. Pregnancy test is required for all women of childbearing potential at baseline. Investigator judgment is used to determine when a pregnancy test is needed during follow up.\n\nStudy Eye: (A participant can have two study eyes.)\n\n* Traction retinal detachment involving the macula\n* Significant vitreous hemorrhage that would preclude completion of a full PRP\n* Significant vitreomacular traction\n* Any prior vitrectomy\n* Any prior PRP (defined as ≥100 burns outside of the posterior pole)\n* Treatment for DME within the prior 6 months\n* Intravitreal anti-VEGF for any indication, other than DME, within the prior year","18 Years",{"count":106,"type":20},426,[53],"This randomized trial will compare treatment strategies for proliferative diabetic retinopathy (PDR). Participants will receive either combination a of faricimab + PRP or vitrectomy + endolaser. The participants will be followed for 3 years. The study will evaluate long-term visual acuity as well as differences in number of injections, procedures, and complications during follow-up (after completion of randomization treatment), and cost.",[110],"Proliferative Diabetic Retinopathy (PDR)",[112,113,114,115],"faricimab","vitrectomy","endolaser","panretinal photocoagulation","2026-06-12",{"date":118,"type":31},"2026-06-15",{"date":120,"type":31},"2025-08-04",{"date":122,"type":20},"2031-08",{"name":37,"class":38},28,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":51,"phases":135,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},"100504184","phase-3-intravitreal-faricimab-injections-or-fluocinolone-acetonide-019-mg-intravitreal-implants-vs-observation-for-prevention-of-va-loss-due-to-radiation-retinopathy-100504184","NCT05844982","Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy","A Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss Due to Radiation Retinopathy","AL","Key Inclusion Criteria\n\n* Primary uveal melanoma (excluding iris melanoma) receiving primary treatment with plaque brachytherapy\n* Absence of unrelated cause of visual loss\n* Baseline visual acuity ≥ 34 letters (20\u002F200 Snellen equivalent or better)\n* Posterior tumor margin \\>0 mm from the center of the macula (i.e., tumor is NOT under the geometric center of the fovea)\n* Posterior tumor margin \\>0 mm from the closest disc margin (i.e., tumor is not touching the edge of the optic disc)\n* Calculated total dose to center of the macula ≥30 Gy\n\nKey Exclusion Criteria\n\n* Opaque media\n* Inability to undergo fluorescein angiography\n* Less than 18 years of age\n* Prior vitrectomy\n* Intraocular pressure (IOP) ≥ 25 mmHg or history of steroid- induced IOP elevation that required treatment at baseline\n* IOP ≥ 25 mmHg at randomization or increase in IOP ≥ 8 mmHg from baseline to randomization (following steroid challenge",{"count":134,"type":20},600,[53],"This randomized controlled trial will evaluate the effect of intravitreal faricimab or fluocinolone acetonide (FAc) intravitreal implant compared with observation on long-term visual acuity following treatment of choroidal melanoma with iodine-125 plaque brachytherapy.",[138,139],"Radiation Retinopathy","Visual Impairment",[141,142,143,144],"Visual Acuity","Radiation retinopathy","Faricima","Fluocinolone Acetonide",{"date":118,"type":31},{"date":147,"type":31},"2023-11-21",{"date":149,"type":20},"2029-12-26",{"name":37,"class":38},24,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":160,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":51,"phases":163,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},"100450438","randomized-trial-comparing-immediate-vs-deferred-surgery-for-symptomatic-erm-100450438","NCT05145491","Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM","Randomized Trial Comparing Immediate Versus Deferred Surgery for Symptomatic Epiretinal Membranes","Protocol AM","Key Inclusion Criteria:\n\n* Age ≥ 45 years\n* E-ETDRS visual acuity 20\u002F40 or better (≥69 letters)\n\n  o ERM must be thought to be the primary cause of vision loss\n* ERM meeting the following criteria, according to the investigator\n\n  * ERM is not secondary to another condition\n  * Symptoms of visual loss and\u002For distortion (in the opinion of the investigator, the ERM is contributing to the participant's symptoms); either new or worsening in the past 24 months\n  * Epiretinal membrane involving or altering the central 3 mm of the macula on OCT\n  * Distortion within the central subfield due to ERM on OCT\n* Immediate vitrectomy not required (investigator and participant are willing to wait at least 4 weeks to see if vision remains stable without having to proceed to vitrectomy)\n* No known medical problems that will be a contraindication to surgery\n\nKey Exclusion Criteria:\n\n* History of retinal vascular disease\n* History of vitreous hemorrhage if vitreous hemorrhage is thought to have caused the ERM\n\n  o History of vitreous hemorrhage is permitted provided the vitreous hemorrhage did not cause the ERM in the investigator's opinion\n* History of inflammatory disease unless mild and completely resolved at least one year prior to randomization\n* History of diabetic macular edema (DME), retinal vein occlusion (RVO), or uveitis (except mild uveitis that resolved \\>1 year prior to randomization)\n* Prior intraocular surgery (except uncomplicated cataract extraction)\n* Cataract extraction within prior 3 months\n* Laser or cryosurgical retinopexy within one month of randomization\n* Pneumatic retinopexy within one year of randomization\n* Current untreated retinal tear or detachment\n\n  o A previously treated retinal tear with up to one disc diameter radius of subretinal fluid is permitted\n* Macular hole\n* Degenerative lamellar macular hole\n\n  o ERM foveoschisis (\"tractional\" lamellar hole) is permitted\n* Vitreomacular traction within 1,500 microns of foveal center\n* Central serous chorioretinopathy\n* Nonproliferative diabetic retinopathy or worse (DR severity \\>20)","50 Years",{"count":162,"type":20},400,[164],"NA","Vitrectomy to remove an epiretinal membrane (ERM) is one of the most common procedures performed by retinal surgeons. Patients who present with significant macular changes on optical coherence tomography (OCT) but relatively good vision are often advised to defer surgery until vision declines to 20\u002F40 or worse. However, it is unknown if delaying surgery, which allows the foveal architecture to remain compromised and potentially to deteriorate, results in worse visual acuity outcomes than if surgery is performed earlier. In addition, there is a need to better understand predictors of outcomes when surgery is performed and predictors of progression when surgery is deferred. Finally, one of the most common presenting symptoms from an ERM is distortion or metamorphopsia. There are several objective measures of metamorphopsia but none have ever been employed to evaluate ERMs in a randomized clinical trial (RCT) and their usefulness is unknown. The purposes of this study are to better understand the optimal timing of surgery to produce the best visual result, to better understand predictors of outcomes in those who undergo surgery and predictors of progression in those whose are observed, and to better characterize and evaluate the usefulness of metamorphopsia and reading speed measures.",[167],"Epiretinal Membrane",{"date":118,"type":31},{"date":170,"type":31},"2022-02-22",{"date":172,"type":20},"2026-12-31",{"name":37,"class":38},47,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":160,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":51,"phases":183,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},"100508715","phase-3-home-oct-guided-treatment-versus-treat-and-extend-for-the-management-of-neovascular-amd-100508715","NCT05904028","Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD","AO","Key Inclusion Criteria:\n\n* Age ≥ 50 years\n* Have the capacity to consent on his\u002Fher own behalf\n* Able to successfully and independently complete at least one self-scanning session on the Home OCT device located at the enrolling clinical site\n* Willing to perform once daily Home OCT monitoring tests for 2 years without significant interruption (such as travel of more than 14 days)\n* Best corrected E-ETDRS visual acuity ≥24 ETDRS letters (approximately 20\u002F320 or better (Snellen))\n* Previously untreated, active MNV lesion (i.e., any intraretinal or subretinal fluid within the center 3 mm diameter circle on OCT) secondary to age-related macular degeneration\n* ≥ 1 intermediate drusen (≥ 63 microns) in either eye OR late AMD (MNV or macular atrophy) in the contralateral eye\n\nKey Exclusion Criteria for Study Eye:\n\n* Previous treatment for MNV (intravitreal injection of any anti-VEGF or anti-VEGF\u002Fanti-Ang2 agent, or any other AMD therapy)\n* Prior treatment with intravitreal injection of any anti-VEGF or anti-VEGF\u002Fanti-Ang2 agent or with macular laser for any indication\n* Treatment with intravitreal corticosteroids within the last 6 months\n* A condition that, in the opinion of the investigator, would preclude participation in the study or ability to complete daily Home OCT scans for 2 years (e.g., unstable medical status that may preclude successful completion of follow-up, dementia, Alzheimer's disease, uncontrollable tremors)\n* MNV due to other causes, such as ocular histoplasmosis, central serous choroidopathy, or pathologic myopia",{"count":134,"type":20},[53],"Home optical coherence tomography- guided treatment versus treat and extend for the management of neovascular age-related macular degeneration.",[186],"Neovascular Age-related Macular Degeneration",[188],"optical coherence tomography","2026-05-15",{"date":191,"type":31},"2026-05-18",{"date":193,"type":31},"2023-11-09",{"date":195,"type":20},"2027-07-30",{"name":37,"class":38},65,{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":205,"enrollmentInfo":206,"targetDuration":208,"studyType":21,"phases":4,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":222},"100632780","a-study-of-uveitis-in-children-18-years-of-age-100632780","NCT07518134","A Study of Uveitis in Children \u003C18 Years of Age","UV1","Inclusion Criteria:\n\n* Age:\n\n  * Incident cases (onset ≤ 6 months) \\\u003C17 years\n  * Established cases (onset \\> 6 months) \\\u003C18 years\n* Diagnosis of any type of uveitis (infectious or noninfectious) in any location except traumatic and post-operative uveitis.\n* Active or inactive uveitis with any treatment status (current \u002F prior \u002F none \\[but under surveillance\\]).\n\nExclusion Criteria:\n\n* Bilateral uveitis with differing etiologies\n* Traumatic uveitis\n* Post-operative uveitis\n* Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is an investigative site personnel directly affiliated with this study or who is an employee of JAEB Center for Health Research.\n* Ocular disease related to Retinoblastoma, Coat's disease, retinitis pigmentosa, inherited retinal degeneration, Juvenile xanthogranuloma (JXG), or leukemia\u002Fmalignancy within the eye.","17 Years",{"count":207,"type":20},300,"12 Months","The goal of this observational study is to collect data regarding clinical features and current\u002Fpast treatments in children under 18 with uveitis. The main questions it aims to answer are:\n\n* What are the frequency of uveitis subtypes in children?\n* What are clinical and demographic characteristics overall and within each type of uveitis?\n\nParticipants will complete one enrollment visit with their doctor. Participants with uveitis onset \\\u003C6 months from enrollment date will also partake in a 12 month chart review.",[211],"Uveitis",[61,213],"uveitis","2026-05-07",{"date":216,"type":31},"2026-05-08",{"date":218,"type":31},"2026-04-14",{"date":220,"type":20},"2028-04",{"name":37,"class":38},4,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":51,"phases":232,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":4},"100636603","phase-4-longitudinal-study-of-retinal-function-in-eyes-treated-for-diabetic-macular-edema-with-anti-vegf-agents-100636603","NCT07567833","Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents","AS","Key inclusion criteria:\n\n* Age ≥18 years\n* Diagnosed with Type 1 or Type 2 diabetes\n* Best corrected visual acuity 20\u002F320 or better (Snellen) (≥24 ETDRS letters)\n* At least 1 eye with CI-DME requiring treatment\n* Able and willing to provide informed consent.\n\nKey exclusion criteria:\n\n* Ocular or systemic condition, aside from diabetes mellitus (DM), that is likely to affect the assessment of DRSS, DME, or the functioning of the neural retina.\n* Previous treatment of any kind for diabetic retinopathy or DME\n* Any condition that may preclude adequate imaging of the macula (e.g. dense cataract or other media opacity, ptosis)\n* History of rhegmatogenous retinal detachment or macular hole\n* History of vitrectomy\n* Intraocular surgery (including cataract surgery) within 4 months prior to enrollment or anticipated within the next 6 months",{"count":231,"type":20},100,[233],"PHASE4","A considerable hurdle to the development of novel, more effective therapies for diabetic retinal disease is the limited number of primary endpoints available for use in regulatory trials. Current endpoints necessitate long trial durations and a greater number of participants to show efficacy. Thus, a better understanding of the structural and functional changes in the retina occurring in people with diabetes is essential for developing primary endpoints and validating surrogate and clinical endpoints.",[236],"Diabetic Retinal Disease","NOT_YET_RECRUITING","2026-04-28",{"date":240,"type":31},"2026-05-05",{"date":242,"type":20},"2026-05-01",{"date":244,"type":20},"2033-05",{"name":37,"class":38},{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":253,"maxAge":205,"enrollmentInfo":254,"targetDuration":4,"studyType":51,"phases":256,"briefSummary":257,"conditions":258,"keywords":260,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":4},"100629093","phase-3-a-randomized-trial-of-botulinum-toxin-a-vs-strabismus-surgery-for-esotropia-10-to-30pd-100629093","NCT07470164","A Randomized Trial of Botulinum Toxin A vs Strabismus Surgery for Esotropia >10 to ≤30PD","ETS4","1. A constant or intermittent ET needing intervention with BTX-A or surgery in the judgement of the investigator meeting one of the criteria below:\n\n   Infantile Esotropia (IET)\n   * Onset prior to six months of age by parental history.\n   * Angle measuring \\>10 to ≤ 30 PD by PACT in the primary position at distance fixation on an accommodative target.\n\n   Acquired Non-accommodative Esotropia (ANAET)\n   * Onset after six months of age by parental history\n   * Angle decreases less than 10 PD by PACT in the primary position at distance fixation with hyperopic correction.\n   * Residual angle measuring \\>10 to ≤ 30 PD by SPCT in the primary position at distance fixation on an accommodative target.\n\n   Acquired Partially Accommodative Esotropia (APAET)\n   * Onset after six months of age by parental history\n   * Angle decreases 10 PD or more by PACT in the primary position at distance fixation with correction.\n   * Residual angle measuring \\>10 to ≤ 30 PD by SPCT in the primary position at distance fixation on an accommodative target.\n2. Age at enrollment:\n\n   * For IET: \\> 4 months to \\\u003C17 years old\n   * For ANAET or APAET: \\>6 months to \\\u003C17 years old\n3. No myopia ≥ 6.00D SE\n4. Current Spectacle Correction at Time of Enrollment\n\n   * For IET: No spectacle wear prior to enrollment.\n   * For ANAET or APAET: Must be wearing spectacles if significant refractive error as defined below based upon a cycloplegic refraction within 6 months of enrollment. If no significant refractive error, spectacles are at investigator discretion. In either case full hyperopic correction by cycloplegia worn for at least 2 weeks.\n5. Requirements for Spectacle Correction (if worn)\n\n   * If myopia is \\\u003C 6.00D SE, then full CR must be worn for at least 2 weeks.\n   * For children \\\u003C 5 years of age who have significant hyperopic refractive error (CR ≥ +2.50D SE), full hyperopic correction, determined by CR must have been worn for at least 2 weeks.\n   * For children ≥ age 5 years, with significant hyperopic refractive error who are unable to tolerate correction of full CR due to blur, then maximally-tolerated hyperopic correction determined both with and without cycloplegia is prescribed and must be worn for at least 2 weeks.\n   * For patients who do not have significant hyperopic refractive error (CR \\\u003C +2.50D SE), whether to prescribe spectacles is at investigator discretion. However, if the investigator elects to prescribe spectacles, the full tolerated hyperopic correction determined with and without cycloplegia must have been worn for at least 2 weeks.\n6. Parent or legal guardian available for follow-up, has home phone (or access to phone), and willing to be contacted by Jaeb Center staff\n7. Gestational age \\> 34 weeks\n8. Birth weight \\> 1500 grams\n9. No use of atropine within the last two weeks.\n10. No history of CNS disease (e.g., IVH, PVL, meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy)\n11. No significant developmental delay in the investigator's judgment (isolated speech delay excepted)\n12. No limitation of abduction consistent with paralytic or restrictive myopathy (minor limitation of abduction due to cross fixation is acceptable)\n13. No craniofacial malformation affecting the orbits\n14. No prior BTX-A injection for strabismus\n15. No prior extraocular muscle surgery or intraocular surgery\n16. No structural ocular abnormalities (e.g., media opacity, optic atrophy, optic nerve hypoplasia, retinal detachment)\n17. No immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is investigative site personnel directly affiliated with this study or who is an employee of the Jaeb Center for Health Research.","4 Months",{"count":255,"type":20},244,[53],"Childhood esotropia (ET) is a common cause of visual disability, and its early management is critical for optimal visual and developmental outcomes.\n\nThe proposed study addresses a need to evaluate botulinum toxin A (BTX-A) as a less invasive, cost-effective alternative to incisional strabismus surgery. If BTX-A is demonstrated to be non-inferior to incisional strabismus surgery in treating ET \\>10 to ≤30PD, this could reduce surgical and anesthesia-related risks in infants, lower the economic burden on families and healthcare systems, and reduce disparities in access to care, particularly in underserved settings where surgical resources are limited.",[259],"Esotropia",[261,61,262,263],"strabismus","botox","botulinum toxin a","2026-03-31",{"date":266,"type":31},"2026-04-06",{"date":268,"type":20},"2027-01",{"date":270,"type":20},"2030-01",{"name":37,"class":38},{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":234,"conditions":281,"keywords":4,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":4},"100613710","longitudinal-natural-history-study-of-retinal-function-in-eyes-of-patients-with-diabetes-100613710","NCT07270133","Longitudinal Natural History Study of Retinal Function in Eyes of Patients With Diabetes","AR","Key Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosed with Type 1 or Type 2 diabetes or non-diabetic control patients\n* Best corrected visual acuity 20\u002F32 or better (Snellen) (≥74 ETDRS letters)\n* Meets criteria for one of the defined observational groups below\n* Able and willing to provide informed consent\n\nKey Exclusion Criteria:\n\n* Ocular or systemic condition, aside from diabetes mellitus (DM), that is likely to affect the assessment of DRSS, DME, or the functioning of the neural retina\n* Previous treatment of any kind for diabetic retinopathy or DME\n* Any condition that may preclude adequate imaging of the macula (e.g. dense cataract or other media opacity, ptosis)\n* History of rhegmatogenous retinal detachment or macular hole\n* History of vitrectomy\n* Intraocular surgery (including cataract surgery) within 4 months prior to enrollment or anticipated within the next 6 months\n* Requiring treatment for DR\u002FDME in the next 6 months",{"count":280,"type":20},450,[236],"2026-03-26",{"date":284,"type":31},"2026-04-01",{"date":286,"type":20},"2026-05-02",{"date":288,"type":20},"2032-12",{"name":37,"class":38},{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":205,"enrollmentInfo":298,"targetDuration":4,"studyType":51,"phases":300,"briefSummary":302,"conditions":303,"keywords":305,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":311,"leadSponsor":313,"locationsCount":4},"100631118","phase-2-omega-3-supplementation-vs-demodex-vs-eyelid-cleanser-for-pediatric-chalazia-100631118","NCT07496515","Omega-3 Supplementation vs Demodex vs Eyelid Cleanser for Pediatric Chalazia","A Randomized Trial of Omega-3 Dietary Supplementation, Anti Demodex Eyelid Cleanser, and Standard Eyelid Cleanser for Pediatric Chalazia","CH01","Inclusion Criteria:\n\n* Age 4 to \\\u003C17.0 years.\n* At least one chalazion measuring \\>3 mm, visible without special instrumentation.\n* Chalazion onset (all current lesions) within the past 6 months by parental report.\n* Willing to forego non-study use of omega-3 supplements (i.e., pills, liquid, gummies) for the duration of the study.\n* Prior or current treatment with warm compresses, eyelid cleanser\u002Fscrubs, topical antibiotic, and\u002For topical steroids IS allowed.\n* Topical antibiotics and topical steroids must be discontinued at study enrollment.\n* All non-study treatments for chalazia must be discontinued at enrollment for the first 8 weeks of the study.\n* Parent seeking treatment for child's chalazion\u002Fchalazia.\n* There is a working microwave oven\u002Fand refrigerator in the home.\n* Parent has a smartphone or other digital device that can take photographs.\n* Parent is able and willing to take photographs and upload them to the PEDIG website.\n* The parent and participant are willing to comply with the assigned treatment regimen after an in-office trial of Cliradex® and Physician Recommended Nutraceuticals (PRN)® Eye Omega Benefits for Kids\n* Willing to consume fish-based oral supplements.\n* Contact lens correction of refractive error is allowed.\n\nExclusion Criteria:\n\n* Current chalazion on any eyelid present for over 6 months by parental report.\n* Use of oral omega-3 supplements (i.e., pills, liquid, gummies) in the last 2 months.\n* Use of oral antibiotics or oral steroids within the prior 2 weeks.\n* Use of anti-Demodex treatment in the last 2 months.\n* Current or prior use of implanted steroids.\n* Prior surgery or injection for chalazia on any eyelid within the previous 6 months.\n* Presence of ptosis as defined by 2-mm or smaller marginal light-reflex distance 1 (MRD-1) (distance from corneal light reflex and bottom of upper eyelid). This includes ptosis covering the visual axis. Sectoral mechanical ptosis in the area of chalazia is allowed if the visual axis is not obscured, and the investigator does not deem the ptosis visually significant.\n* History of ptosis surgery.\n* Any conjunctivitis (e.g., phlyctenular keratoconjunctivitis, allergic, bacterial, and\u002For vernal) requiring treatment other than antihistamines, artificial tears, and\u002For cold compresses.\n* Intraocular inflammation of any kind within the last month.\n* Intraocular conditions that in the investigator's opinion may require use of oral or intraocular steroids, or systemic immunotherapy within the next year.\n* Current corneal erosion, infiltrates, ulcers, significant neovascularization (within 3 mm of optical center), or history of corneal graft or central corneal scarring\n* Known hypersensitivity or allergy to Cliradex® Towelette ingredients including terpinen-4-ol, a tea tree oil derivative.\n* Known hypersensitivity or allergy to OCuSOFT® eyelid Scrub Plus Pre-Moistened Pads or its ingredients (Polyhexamethylene biguanide preservative (PHMB), provitamin B5, and decyl glucoside).\n* Known hypersensitivity or allergy to Bruder® mask\n* Ocular rosacea.\n* Known hypersensitivity or allergy of fish or seafood.\n* Known hypersensitivity or allergy to oral omega-3 supplements\n* Unable to consume liquid supplements orally.\n* Consumption of fish 4 or more times a week (on average).\n* Bleeding disorder or taking any anticoagulants\u002Fantiplatelet medications.\n* Daily use of non-steroidal anti-inflammatory (NSAID) or blood-pressure-lowering medications.\n* Current chemotherapy treatment.\n* Current use of orlistat (Xenical or Alli).\n* Current use of any other medication that the investigator feels may significantly interact with omega 3 supplementation, not including oral contraceptives.\n* Diagnosis of any of the following conditions:\n\n  * diabetes mellitus\n  * heart rhythm disorder\n  * underactive thyroid\n  * liver disease\n  * pancreatic disease\n* Moving outside the area in the next 12 months.\n* Other family member participating in the study.\n* Immediate family member (i.e., parent or legal guardian, sibling) is an investigator, coordinator, or certified tester directly affiliated with this study or an employee of the JAEB Center for Health Research.\n* Has previously been randomized as a participant in this study.\n* Developmental delays\u002Fsensory sensitivities that parents or the investigator feel would interfere with study treatment.\n* Pregnancy, lactating or planning on becoming pregnant during study participation.",{"count":299,"type":20},168,[301],"PHASE2","Participants enrolled into the study will be prescribed twice daily warm compresses for 8 weeks and randomly allocated (1:1:1) to receive either 1) Oral omega-3 supplementation and standard eyelid cleanser, 2) Anti-Demodex eyelid cleanser, or 3) Standard eyelid cleanser as treatment for chalazia.\n\nParticipants will return for a visit after 8 weeks for a masked clinical exam to determine whether the chalazia has improved or resolved. The 8-week visit will also include a masked central reader's assessment of parent photographs, parental palpation of eyelids, and review of Parental Treatment Outcome Question as part of a telehealth objective.\n\nAfter the 8-week visit, treatment is at investigator discretion other than 1) the OMEGA-3 group must continue the study-prescribed omega-3 supplementation and 2) the ANTI-DEMODEX and STANDARD groups must not receive omega-3 supplementation.\n\nParticipants will be followed from 8 weeks to 12 months from baseline to determine the proportion of participants with new chalazia based on monthly parental report and office visits at 6 months and 12 months.",[304],"Pediatric Chalazia",[61,306],"chalazia","2026-03-23",{"date":309,"type":31},"2026-03-27",{"date":65,"type":20},{"date":312,"type":20},"2028-02-01",{"name":37,"class":38},{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":11,"sex":16,"minAge":321,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":324,"conditions":325,"keywords":334,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":354},"100580429","studying-the-presence-of-cfrd-complications-with-thoughtful-recruitment-spectrum-100580429","NCT06837181","Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM)","SPeCTRuM","Inclusion Criteria:\n\n* Written informed consent (and assent when applicable) obtained from participant or participant's legally authorized representative\n* For Adults: Must be able to consent on one own's behalf (i.e., cannot lack cognitive capacity to consent due to the required patient-reported outcomes)\n* Be willing and able to adhere to the study protocol requirements\n* Age ≥ 12 years at time of enrollment\n* CF diagnosis based on two CF causing mutations and\u002For positive sweat test according to CFF diagnostic criteria\n* CFRD diagnosis ≥ 5 years at time of enrollment\n\nExclusion Criteria:\n\n* History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject\n* History of transplant\n* Pregnancy reported by participant at time of consent or at any point during active study participation\n\nPulse Wave Velocity Exclusion Criteria:\n\n* Erratic, accelerated or mechanically controlled irregular heart rhythms including arrhythmias\n* Carotid or aortic valve stenosis\n* Peripheral artery disease or leg artery disease\n* Generalized constriction or localized spasm of muscular conduit arteries such as seen immediately after hypothermic cardiopulmonary bypass surgery or accompanying Raynaud's phenomena or intense cold.\n* Possible exclusions based on investigator medical provider assessment (additional precautions may be followed to allow inclusion):\n\n  * Pressure reading should not be conducted on a limb where there is intravenous access, arterio-venous shunt, or where circulation is compromised.\n  * Pressure reading should not be conducted on the side of the body that a mastectomy was done.","12 Years",{"count":323,"type":20},200,"This multicenter cross-sectional study will include a diverse population of adolescents and adults with CF.\n\nThe overall Aim is to describe prevalence of diabetes microvascular complications and macrovascular surrogates in people with established CFRD.",[326,83,327,328,329,330,331,332,333],"Cystic Fibrosis (CF)","Diabetes","Retinopathy","Neuropathy","Nephropathy","Blood Pressure","Cardiovascular Risk","Microvascular",[335,336,337,338,339,88,340,327,341,342,343,344,345],"Cystic Fibrosis","CFRD","Cystic Fibrosis-Related Diabetes","Observational","Physical Activity Tracker","CGM","blood pressure","cardiovascular risk","microvascular","diabetes complications","social determinants of health","2026-02-09",{"date":348,"type":31},"2026-02-10",{"date":350,"type":31},"2025-09-18",{"date":352,"type":20},"2028-11-30",{"name":37,"class":38},18,{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":16,"minAge":363,"maxAge":321,"enrollmentInfo":364,"targetDuration":4,"studyType":51,"phases":366,"briefSummary":367,"conditions":368,"keywords":370,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":384},"100556421","phase-3-dichoptic-treatment-for-amblyopia-in-children-8-to-12-years-of-age-100556421","NCT06524882","Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age","A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age","ATS24","Inclusion Criteria:\n\n1. Age 8 to \\\u003C13 years.\n2. VA, measured in each eye without cycloplegia in current refractive correction (if applicable) using the E-ETDRS VA protocol on a study-approved device displaying single surrounded optotypes, as follows:\n\n   1. VA in the amblyopic eye 20\u002F40 to 20\u002F200 inclusive (33 to 72 letters with E-ETDRS).\n   2. VA in the fellow eye 20\u002F25 or better (≥ 78 letters with E-ETDRS).\n   3. Interocular difference ≥ 3 logMAR lines (≥ 15 letters) i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA).\n3. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated).\n\n   1. Criteria for strabismic amblyopia: At least one of the following must be met:\n\n      * Presence of a heterotropia on examination at distance or near fixation (with optical correction), must be \\\u003C=5 prism diopters (∆) by SPCT at distance and near fixation.\n      * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia).\n   2. Criteria for anisometropia: At least one of the following criteria must be met:\n\n      * ≥1.00 D difference between eyes in spherical equivalent (SE).\n      * ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.\n   3. Criteria for combined-mechanism: Both of the following criteria must be met:\n\n      * A criterion for strabismus is met (see above).\n      * ≥1.00 D difference between eyes in SE OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.\n4. No more than 2 weeks (cumulative) of prior dichoptic treatment\n5. No treatment with cycloplegic eyedrops (e.g., atropine) in the past 2 weeks; other treatments allowed up to enrollment but then must be discontinued.\n6. Refractive correction is required (single vision lenses or contact lenses) for any of the following refractive errors based on a cycloplegic refraction completed within the last 7 months:\n\n   * Hypermetropia of 2.50 D or more by SE\n   * Myopia of amblyopic eye of 0.50D or more SE\n   * Astigmatism of 1.00D or more\n   * Anisometropia of more than 0.50D SE\n\n   NOTE: Children with cycloplegic refractive errors that do not fall within the requirements above for refractive correction may be given refractive correction at investigator discretion but must follow the study-specified prescribing guidelines, as detailed below.\n\n   NOTE: Monocular or binocular contact lens wear is allowed provided the contact lenses meet the refractive error correction requirements below. For each child, all testing must be performed using the same form of optical correction (i.e., no changing between contacts and spectacles).\n   1. Spectacles\u002Fcontact lens correction prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:\n\n      * SE must be within 0.50D of fully correcting the anisometropia (if new glasses are prescribed, reduction in plus sphere must be symmetric in the two eyes).\n      * SE must not be under corrected by more than 1.50D SE.\n      * Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism.\n      * Axis must be within +\u002F- 10 degrees if cylinder power is ≤1.00D, and within +\u002F- 5 degrees if cylinder power is \\>1.00D.\n      * Myopia must not be under corrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes.\n   2. Spectacles\u002Fcontact lens correction (with or without other treatment such as patching) meeting the above criteria must be worn:\n\n      * For at least 18 weeks OR until VA stability is documented (defined as \\\u003C1-line change by the same testing method measured on 2 consecutive exams at least 9 weeks apart).\n      * For determining VA stability (non-improvement):\n\n        * The first of two measurements may be made 1) in current correction, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed),\n        * The second measurement must be made without cycloplegia in the correct spectacles\u002Fcontact lens correction that has been worn for at least 9 weeks.\n        * NOTE: Because this determination is a pre-randomization, the method of measuring VA is not mandated.\n7. Participant is willing to wear a headset.\n8. Participant is willing to continue full-time spectacles\u002Fcontact lens wear (if needed).\n9. Interpupillary distance of 52mm to 72mm inclusive.\n10. Investigator is willing to prescribe continued spectacles\u002Fcontact lens correction (if needed) or either dichoptic device per protocol.\n11. Participant is willing to accept assignment to either continued spectacles\u002F contact lens wear alone, dichoptic movies\u002Fshows (view 1 hour per day 6 days per week) OR dichoptic games (play approximately 25 minutes per day, 6 days per week) for 19 weeks.\n12. Parent understands the protocol and is willing to accept randomization.\n13. Parent has phone (or access to phone) and is willing to be contacted by JAEB Center staff.\n14. Relocation outside of area of an active PEDIG site for this study within the next 36 weeks is not anticipated.\n\nExclusion Criteria:\n\n1. Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction)\n2. Prism greater than a total of 8 diopters horizontal and 1 diopter vertical in the refractive correction at time of enrollment.\n3. Current bifocal spectacles (eligible only if bifocal discontinued 2 weeks prior to enrollment).\n4. Myopia greater than -6.00D spherical equivalent in either eye.\n5. Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met using patch occlusion. Fogging is not permitted).\n6. Diplopia more than once per week over the last week prior to enrollment by parental report.\n7. History of light-induced seizures.\n8. Known simulator sickness.\n9. Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and\u002For learning disabilities are not excluded.\n10. Immediate family member (biological or legal guardian, child, sibling, parent) of investigative site personnel directly affiliated with this study or an employee of the JAEB center for Health Research.","8 Years",{"count":365,"type":20},252,[53],"Participants eligible for the study will be randomly allocated (1:1:1) to receive either Luminopia dichoptic treatment while wearing optical correction if needed, Vivid Vision dichoptic treatment while wearing optical correction if needed, or continued optical correction alone if needed, with clinical assessments at 9- and 18-weeks post-randomization.\n\nAt the 18-week primary outcome visit, participants who were randomly assigned to receive optical correction alone if needed with an IOD of 1 logMAR line (5 letters) or more, will be offered randomization to Luminopia or Vivid Vision dichoptic therapy and if they accept, followed forward with visits at 27- and 36-weeks post-randomization.\n\nThe study will end for all other participants at 18 weeks.",[369],"Amblyopia",[371,372,373,374,375,376],"Dichoptic","Luminopia","Vivid Vision","Game","movie","glasses",{"date":378,"type":31},"2026-02-11",{"date":380,"type":31},"2024-10-22",{"date":382,"type":20},"2027-11-01",{"name":37,"class":38},58,{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":393,"enrollmentInfo":394,"targetDuration":4,"studyType":51,"phases":396,"briefSummary":397,"conditions":398,"keywords":399,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":407},"100545331","phase-3-dichoptic-treatment-for-amblyopia-in-children-4-to-7-years-of-age-100545331","NCT06380517","Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age","A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age","ATS23","At the time of enrollment, individuals must meet all the following inclusion criteria to be eligible to participate in the study.\n\n1. Age 4 to 7 years.\n2. Visual acuity, measured in each eye without cycloplegia in current refractive correction (if applicable) using the ATS-HOTV VA protocol on a study-approved device displaying single surrounded optotypes, as follows:\n\n   1. VA in the amblyopic eye 20\u002F40 to 20\u002F200 inclusive.\n   2. Age-normal VA in the fellow eye:44,45\n\n      • 4 years: 20\u002F40 or better; 5-6 years: 20\u002F32 or better; 7 years: 20\u002F25 or better\n   3. Interocular difference ≥ 3 logMAR lines (i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA).\n3. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated).\n\n   1. Criteria for strabismic amblyopia: At least one of the following must be met:\n\n      * Presence of a heterotropia on examination at distance or near fixation (with optical correction), must be \\\u003C=5 prism diopters (∆) by SPCT at distance and near fixation (see #7 below).\n      * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia).\n   2. Criteria for anisometropia: At least one of the following criteria must be met:\n\n      * ≥1.00 D difference between eyes in spherical equivalent (SE).\n      * ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.\n   3. Criteria for combined-mechanism: Both of the following criteria must be met:\n\n      * A criterion for strabismus is met (see above).\n      * ≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.\n4. No more than 2 weeks (cumulative) of prior dichoptic treatment.\n5. No treatment with cycloplegic eyedrops (e.g., atropine) in the past 2 weeks; other treatments allowed up to enrollment but then must be discontinued.\n6. Refractive correction is required (single vision lenses or contact lenses) for any of the following refractive errors based on a cycloplegic refraction completed within the last 7 months:\n\n   * Hypermetropia of 2.50 D or more by SE\n   * Myopia of amblyopic eye of 0.50D or more SE\n   * Astigmatism of 1.00D or more\n   * Anisometropia of more than 0.50D SE\n\n   NOTE: Monocular or binocular contact lens wear is allowed provided the contact lenses meet the refractive error correction requirements below. For each child, all testing must be performed using the same form of optical correction (i.e., no changing between contacts and spectacles).\n   1. Spectacles\u002Fcontact lens correction prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:\n\n      * SE must be within 0.50D of fully correcting the anisometropia (if new glasses are prescribed, reduction in plus sphere must be symmetric in the two eyes).\n      * SE must not be under corrected by more than 1.50D SE.\n      * Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism.\n      * Axis must be within +\u002F- 10 degrees if cylinder power is ≤1.00D, and within +\u002F- 5 degrees if cylinder power is \\>1.00D.\n      * Myopia must not be under corrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes.\n   2. Spectacles\u002Fcontact lens correction (with or without other treatment such as patching) meeting the above criteria must be worn:\n\n      * For at least 18 weeks OR until VA stability is documented (defined as \\\u003C0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 9 weeks apart).\n      * For determining VA stability (non-improvement):\n\n        * The first of two measurements may be made 1) in current correction, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed),\n        * The second measurement must be made without cycloplegia in the correct spectacles\u002Fcontact lens correction that has been worn for at least 9 weeks.\n        * NOTE: Because this determination is a pre-randomization, the method of measuring VA is not mandated.\n7. Participant is willing to wear the Luminopia headset.\n8. Participant is willing to continue full-time spectacles\u002Fcontact lens wear (if needed).\n9. Participant is willing to accept assignment to either dichoptic shows (view 1 hour per day 6 days per week) OR part-time patching (2 hours per day 7 days per week) for 26 weeks.\n10. Interpupillary distance of 52mm to 72mm inclusive.\n11. Investigator is willing to prescribe Luminopia or patching per protocol.\n12. Parent understands the protocol and is willing to accept randomization.\n13. Parent has phone (or access to phone) and is willing to be contacted by JAEB Center.\n14. Relocation outside area of active PEDIG site within the next 52 weeks is not anticipated.\n\nIndividuals meeting any of the following criteria will be excluded from study participation.\n\n1. Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction)\n2. Prism lenses or need of a prism prescription at enrollment.\n3. Current bifocal spectacles (eligible only if bifocal discontinued 2 weeks prior to enrollment).\n4. Myopia greater than -6.00D spherical equivalent in either eye.\n5. Previous intraocular or refractive surgery.\n6. Known skin reactions to patch or bandage adhesives.\n7. Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met using patch occlusion. Fogging is not permitted).\n8. Diplopia more than once per week over the last week prior to enrollment by parental report.\n9. History of light-induced seizures.\n10. Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and\u002For learning disabilities are not excluded.\n11. Participation in a prior study involving patching for amblyopia\n12. Immediate family member (biological or legal guardian, child, sibling, parent) of investigative site personnel directly affiliated with this study or an employee of the JAEB center for Health Research.","7 Years",{"count":395,"type":20},238,[53],"In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies\u002Fshows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks.",[369],[371,372,400,375],"Patching",{"date":378,"type":31},{"date":403,"type":31},"2024-07-01",{"date":405,"type":20},"2028-01-01",{"name":37,"class":38},73,{"id":409,"slug":410,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":11,"sex":16,"minAge":416,"maxAge":417,"enrollmentInfo":418,"targetDuration":4,"studyType":51,"phases":420,"briefSummary":421,"conditions":422,"keywords":423,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":433},"100391577","phase-3-a-randomized-trial-to-evaluate-sequential-vs-simultaneous-patching-100391577","NCT04378790","A Randomized Trial to Evaluate Sequential vs Simultaneous Patching","A Randomized Trial to Evaluate Sequential vs Simultaneous Spectacles Plus Patching for Amblyopia in Children 3 to \u003C13 Years Old","ATS22","Inclusion Criteria:\n\n1. Age 3 to \\\u003C13 years at the time of randomization\n2. Amblyopia associated with anisometropia, strabismus, or both\n\n   o Criteria for strabismic amblyopia: At least one of the following must be met:\n   * Presence of a heterotropia on examination at distance or near fixation (with or without optical correction)\n   * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)\n\n     * Criteria for anisometropia: At least one of the following criteria must be met:\n\n       * 1.00 D difference between eyes in spherical equivalent (SE)\n       * 1.50 D difference in astigmatism between corresponding meridians in the two eyes\n     * Criteria for combined-mechanism amblyopia: Both of the following criteria must be met:\n   * Criteria for strabismus are met (see above)\n\n     * 1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes\n3. No previous treatment for amblyopia, including no more than 24 hours of spectacle wear.\n4. Investigator planning to initiate spectacle correction of refractive error meeting the following criteria based on a cycloplegic refraction that has been performed within 30 days:\n\n   1. Full correction of anisometropia\n   2. Full correction of astigmatism with the same axis found by the cycloplegic refraction\n   3. Full correction of any myopia\n   4. Hyperopia must not be under corrected by more than 1.50 D, and reduction in plus sphere must be symmetric in the two eyes.\n5. At enrollment, single VA measured in each eye assessed in trial frames with the spectacle correction the investigator plans to prescribe, using the investigator's routine method as follows:\n\n   * VA in the amblyopic eye 20\u002F40 to 20\u002F200 inclusive.\n   * Age-normal VA in the fellow eye:40,41\n\n     * 3 years: 0.4 logMAR (20\u002F50) or better\n     * 4 years: 0.3 logMAR (20\u002F40) or better\n     * 5-6 years: 0.2 logMAR (20\u002F32) or better\n     * 7-12 years: 0.12 logMAR (78 letters) or better\n   * Interocular difference ≥ 3 logMAR lines (0.3 logMAR) or ≥ 15 letters o When participants return for the Spectacle Baseline \u002F Randomization Visit with their new spectacles, they will need to meet the same criteria as above using the ATS-HOTV or E-ETDRS protocol after wearing the new spectacles for at least 10 minutes (based upon the mean of a test and retest of VA in those new spectacles).\n6. Investigator is willing to prescribe spectacle wear followed sequentially by patching or simultaneous spectacles and patching treatment per protocol.\n7. Parent understands the protocol and is willing to accept randomization.\n8. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff or other study staff.\n9. Relocation outside of area of an active PEDIG site for this study within the next 56 weeks is not anticipated.\n\nExclusion Criteria:\n\n1. Myopia greater than -6.00 D spherical equivalent in either eye.\n2. Previous intraocular or refractive surgery.\n3. Planned strabismus surgery in the next 56 weeks.\n4. Any previous treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy, or binocular treatment).\n5. Previous spectacle or contact lens wear for more than 24 hours.\n6. Parent and participant willing to forego option of contact lens wear for the duration of the study.\n7. Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above VA criteria are met).\n8. Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and\u002For learning disabilities or attention deficit hyperactivity disorder (ADHD) are not excluded.\n9. Known allergy to adhesive patches.\n10. Known allergy to silicone.","3 Years","13 Years",{"count":419,"type":20},544,[53],"A randomized trial to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to \\\u003C13 years of age.",[369],[424,376,59,425,426],"patching","simultaneous","sequential",{"date":378,"type":31},{"date":429,"type":31},"2020-12-08",{"date":431,"type":20},"2028-05-01",{"name":37,"class":38},68,{"id":435,"slug":436,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":440,"sex":441,"minAge":104,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":51,"phases":444,"briefSummary":445,"conditions":446,"keywords":448,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":459},"100589639","cgm-for-the-early-detection-and-management-of-hyperglycemia-in-pregnancy-100589639","NCT06957028","CGM for the Early Detection and Management of Hyperglycemia in Pregnancy","Inclusion Criteria\n\n1. Maternal age of 18 years and older\n2. Singleton pregnancy\n3. Gestational age up to 14w 6d of pregnancy, determined on ultrasound, for initiation of screening\n\n   • Although it is preferable that ultrasound results be available prior to enrollment, if ultrasound results are not available at the time of enrollment, participant can have CGM initiated but will be dropped if not eligible after results are available\n4. HbA1c \\\u003C6.5% (48 mmol\u002Fmol) since onset of pregnancy\n\n   • If HbA1c result not available at time of enrollment, participant can have blinded screening CGM initiated, but results will be needed prior to randomization to verify eligibility.\n5. No prior history of gestational diabetes mellitus (GDM)\n6. Able to read English or Spanish\n\nExclusion Criteria\n\n1. Signs of abnormal fetal or placental development (suspected fetal anomaly or placenta accreta spectrum, low PAPPA) at first routine prenatal visit\u002Fultrasound\n2. Planned termination of pregnancy or any indications of miscarriage\n3. Prior gastric bypass surgery\n4. Pregravid diabetes (type 1 or type 2)\n5. Unwillingness\u002Finability to wear CGM sensor\n6. Unwillingness to attend routine antenatal obstetric appointments\n7. Use of corticosteroids by a route that can produce hyperglycemia (e.g., oral, intravenous, intramuscular, intra-articular) during the 7 days prior to initiating CGM screening or during the CGM screening\n\n   • Topical and inhaled corticosteroids are acceptable\n8. Use of insulin during the pregnancy prior to enrollment\n9. Use of metformin within one week of the initiation of the blinded CGM sensor for screening or use of a GLP-1 or other weight-reduction medication that can affect glucose levels within 4 weeks of the initiation of the blinded CGM sensor for screening\n10. Deemed unable to participate for medical reasons identified by their physician\n\nAdditional Criteria for RCT Eligibility\n\n1. Screening CGM meeting study criteria for hyperglycemia: 5% to \\\u003C25% time \\>140 mg\u002FdL\n2. Randomization by 16 week 6 days of pregnancy\n3. No participation in a separate intervention trial.",true,"FEMALE",{"count":443,"type":20},6000,[164],"The goal of this clinical trial is to use continuous glucose monitoring (CGM) to quickly detect and manage high blood sugar in pregnant women, early in pregnancy. The main questions it aims to answer are:\n\n(1) any problems for the baby, such as being too large for their age, shoulder injuries (like broken bones), high bilirubin levels needing light treatment, low blood sugar, or needing to stay in the NICU; (2) any high blood pressure issues for the mother during pregnancy.",[447],"Gestational Diabetes Mellitus in Pregnancy",[449,340,450],"GDM","Pregnancy","2025-12-16",{"date":453,"type":31},"2025-12-23",{"date":455,"type":31},"2025-05-27",{"date":457,"type":20},"2027-11-27",{"name":37,"class":38},10,{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":468,"enrollmentInfo":469,"targetDuration":4,"studyType":51,"phases":471,"briefSummary":472,"conditions":473,"keywords":475,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":486},"100583784","effect-of-inhaled-technosphere-insulin-vs-raa-insulin-on-exercise-induced-hypoglycemia-in-adults-with-t1d-using-automated-insulin-delivery-100583784","NCT06880835","Effect of Inhaled Technosphere Insulin vs RAA Insulin on Exercise-Induced Hypoglycemia in Adults With T1D Using Automated Insulin Delivery","INHALE-AIDEx: A Randomized Crossover Trial Evaluating the Effect of Inhaled Technosphere Insulin (Afrezza®) vs Rapid Acting Analogue Insulin on Exercise-Induced Hypoglycemia in Adults With Type 1 Diabetes Using Automated Insulin Delivery","INHALE-AIDEx","Inclusion Criteria:\n\n1. Ability to provide informed consent for study participation\n2. Age ≥18 years to 65 years\n3. Clinical diagnosis of T1D (per the Investigator)\n4. Using Tandem t:slim X2 or Tandem Mobi insulin pump with Control-IQ for at least 90 days prior to screening visit\n5. Using insulin aspart or insulin lispro in Tandem insulin pump\n6. Total daily insulin dose 20 to 80 units\n7. Usual RAA insulin bolus for 50 gram carbohydrate lunch meal is ≤12 units\n8. Physically active, with at least 3 moderate or vigorous exercise sessions ≥30 minutes per typical week self-reported by participant\n9. No medical, psychiatric, or other conditions, or medications being taken that in the Investigator's judgement would be a safety concern for participation in the study\n10. No electrocardiogram (ECG) abnormality that in the judgment of the investigator, which will take into consideration the usual exercise performed by the participant and their overall medical condition, increases the risk of exercise\n11. Investigator believes that the participant can safely follow the protocol\n12. Able to read and understand written and spoken English or Spanish\n\nExclusion Criteria:\n\n1. Use of inhaled insulin within one week prior to screening visit\n2. History of asthma, chronic obstructive pulmonary disease (COPD), or any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease as judged by the Investigator\n3. Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 90 days prior to screening visit and no plans to smoke during the study\n4. History or current diagnosis of lung cancer\n5. Forced expiratory volume in 1 second (FEV1) measurement of \\\u003C70% of predicted Global Lung Function Initiative value\n6. Pregnant or lactating, planning to become pregnant during the study, or is of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral\u002Finjectable contraceptives, IUD, or implant); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal)\n\n   • A pregnancy test is required for any person of childbearing potential.\n7. An event of severe hypoglycemia, as judged by the Investigator, within the 90 days prior to screening visit\n8. An episode of diabetic ketoacidosis (DKA) as defined in section 5.2 within the 90 days prior to screening visit\n9. Any disease other than diabetes or current use (or anticipated use during the study) of any medication (e.g., beta blocker) that, in the judgment of the Investigator, may substantially impact glucose metabolism\n10. Use of a non-insulin glucose-lowering medication (or weight-reduction medication with glucose-lowering effect) within 4 weeks prior to screening visit\n11. Exposure to any investigational drug in the 90 days prior to the screening visit\n12. Current or anticipated acute uses of oral, inhaled, or injectable glucocorticoids during the time period of the study (topical or intranasal glucocorticoid use is acceptable)\n13. Current use of Hydroxyurea medication\n14. Current or anticipated use of a low carbohydrate diet (\\\u003C50 grams\u002Fday) or low calorie diet (\\\u003C800 kcal\u002Fday) during the time period of the study\n15. Current treatment for diabetic retinopathy\n16. Known stage 4\u002F5 chronic kidney disease or on dialysis\n17. Having a direct supervisor at place of employment who is directly involved in conducting the clinical trial (as a study Investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the study","65 Years",{"count":470,"type":20},30,[164],"This investigator-initiated study will enroll about 30 adults 18 to 65 years of age with type 1 diabetes (T1D) who are using the Tandem t:slim X2 insulin pump or Tandem Mobi insulin pump with Control-IQ or Control-IQ+ technology (\"Control-IQ\" which will refer to either Control-IQ or Control-IQ+). The study is being done to find out if inhaled insulin given for a meal is safer and better to use than a bolus of insulin through your pump when you exercise following a meal. Participants are asked to complete three study exercise visits in the clinic.",[474],"Diabetes Mellitus, Type 1",[474,476,477,478],"Exercise","Technosphere Insulin","Automated Insulin Delivery",{"date":480,"type":31},"2025-09-23",{"date":482,"type":31},"2025-06-05",{"date":484,"type":20},"2026-05-31",{"name":37,"class":38},3,{"id":488,"slug":489,"hasResults":11,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":11,"sex":441,"minAge":104,"maxAge":495,"enrollmentInfo":496,"targetDuration":4,"studyType":51,"phases":497,"briefSummary":498,"conditions":499,"keywords":504,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":515},"100557259","phase-2-inhaled-insulin-vs-rapid-acting-injections-for-post-meal-glucose-control-in-women-with-gestational-diabetes-100557259","NCT06535789","Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes","The Safety and Efficacy of Rapid Acting Inhaled Technosphere Insulin (Afrezza) Compared With Subcutaneous Insulin to Achieve Pregnancy-Specific Postprandial Targets Among Patients With Gestational Diabetes","INHALE-GDM","Inclusion Criteria\n\n1. Ability to provide informed consent for study participation\n2. Age ≥18 years and \\\u003C41 years old\n3. Singleton pregnancy at 24-34 weeks gestation\n4. Diagnosis of GDM via standard 1-step or 2-step criteria\n5. Treated with an insulin regimen that includes a RAA bolus of any type for breakfast, with a dose \\\u003C20 units\n6. Pre-pregnancy or first trimester body mass index (BMI) 25-45\n7. Investigator believes that the protocol can be safely conducted by the participant\n8. Able to read and speak English\n\nExclusion Criteria\n\n1. Type 1 diabetes or type 2 diabetes\n2. HbA1c ≥ 6.5%, FBG ≥125 mg\u002Fdl or 2-hr glucose ≥200 mg\u002FdL on 75g OGTT, or random plasma glucose ≥200 mg\u002FdL (consistent with pre-existing diabetes and not GDM diagnosis)\n3. Current use of any non-insulin glucose lowering medication\n4. Using TI (Afrezza), regular insulin, or ≥20 RAA units at breakfast (NPH is permissible)\n5. Peak expiratory flow \\\u003C80% predicted as measured by peak flow meter\n6. Recent history of asthma (defined as using any medications to treat asthma within the last year), chronic obstructive pulmonary disease (COPD), or any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease as judged by the Investigator\n7. Smoking (includes cigarettes, cigars, pipes, and\u002For vaping devices) within 90 days prior to screening\n8. History or current diagnosis of lung cancer\n9. Current or anticipated use of oral, inhaled or injectable glucocorticoids during the time period of the trial (topical glucocorticoid use is acceptable)\n10. Renal or hepatic impairment that in the investigator's judgment poses a safety risk for the study participant\n11. Recurrent Level 2 (blood glucose \\\u003C54 mg\u002FdL) or Level 3 severe hypoglycemia events\n12. Current use of non-cardio-selective beta blockers\n13. Being a member of the study team, having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study Investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial","40 Years",{"count":470,"type":20},[301,53],"Pregnant women aged 18-40 with gestational diabetes (GDM) will take part in this study. We want to see how two different insulin treatments affect their blood sugar after they eat. These women usually use a rapid-acting insulin analog (RAA) that's injected to control their blood sugar before and after meals. They will come to the clinic for two meal sessions. For the first meal, we will randomly decide if they will use the usual RAA insulin or a newer inhaled insulin called technosphere insulin (TI). They will use the other type of insulin for their second meal. After each meal, we will compare their blood sugar levels.",[500,501,502,503],"Diabetes, Gestational","Pregnancy Complications","Glucose Metabolism Disorders","Glucose Intolerance During Pregnancy",[505,506],"Gestational Diabetes","Inhaled Insulin","2025-05-13",{"date":509,"type":31},"2025-05-15",{"date":511,"type":20},"2025-05",{"date":513,"type":20},"2025-07",{"name":37,"class":38},5,{"id":517,"slug":518,"hasResults":11,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":11,"sex":441,"minAge":104,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":526,"conditions":527,"keywords":531,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":459},"100589815","t1d-pregnancy--me-100589815","NCT06959316","T1D Pregnancy & Me","Pregnancy Data Repository to Assess Management of Type 1 Diabetes With Diabetes Technology","PRAM-T1D","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Clinical diagnosis of presumed T1D for at least 6 months duration\n3. Less than 15 weeks gestation at time of enrollment based on due date from provider\n4. Planned CGM use on a regular basis (e.g., ≥10 out of 14 days) and willing to continue using CGM regularly with no plans to discontinue CGM use during the study\n5. Following intensive insulin therapy regimen defined as basal-bolus delivery via an insulin pump (including a closed loop system) or multiple daily injections (MDI)\n6. Have access to technology that may be required to complete study questionnaires and share diabetes device data.\n7. Resident of the United States and plans to reside in the U.S. for the duration of the study\n8. Comprehends written and spoken English or Spanish\n9. Willing and able to provide informed consent, complete surveys and provide the device data that are part of the protocol\n\nExclusion Criteria:\n\n1. Multiple pregnancy\n2. Current renal dialysis or plan to begin renal dialysis during the study\n3. History of liver cirrhosis\n4. Active cancer treatment with systemic chemotherapy\n5. Current participation in other studies involving an investigational insulin delivery device or planning to participate in an investigational insulin delivery device study during pregnancy\n6. Prior participation in this study",{"count":525,"type":20},500,"T1D Pregnancy \\& Me will partner with pregnant participants living with type 1 diabetes (T1D) in the United States to collect real-world data on management of T1D in pregnancy. This is a remote study where participants can complete online surveys and share device data (continuous glucose monitor (CGM) data and insulin data). Through the collection of CGM, insulin, and pregnancy outcome data, the study will provide important information to understand how diabetes is being managed during pregnancy. These data will provide much needed evidence to guide modern management of diabetes during pregnancy with a goal of improving care and outcomes.",[474,528,529,530],"Pregnancy in Diabetics","Pregnancy, High-Risk","Insulin Dependent Diabetes",[532,533,450,534,535,536,537,538,340,539,540,541],"Type 1 diabetes","Pregnant","Insulin pump","Continuous glucose monitor","Remote study","Online study","T1D","Insulin injection","Hybrid closed loop","HCL","2025-04-28",{"date":544,"type":31},"2025-05-06",{"date":546,"type":31},"2025-04-25",{"date":548,"type":20},"2027-04",{"name":37,"class":38},""]