[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"eye-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:eye-diseases":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,43,88,112,143,170,200,228,252,280,303,324,355,381,405,426,442,462,489,521,543,567,588,608,635],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":4,"leadSponsor":39,"locationsCount":42},"100106859","screening-for-research-participants-100106859",false,"NCT00655096","Screening for Research Participants","Screening Protocol for the Evaluation and Diagnosis of Potential Research Participants","* INCLUSION CRITERIA:\n\nParticipants will be able to enroll if they:\n\n* Have a diagnosed ocular disease\u002Fdisorder; OR\n* Potentially have an unusual, interesting, or unknown ocular condition that requires the establishment of a diagnosis; OR\n* Potentially participate as a disease-free control participant in an NEI clinical research study; OR\n* Are an unaffected first-degree relative of a participant with either a diagnosed or undiagnosed ocular disorder; AND\n* Have the ability to understand and sign an informed consent OR if they are minor children have a legal parent\u002Fguardian with the ability to do the same.\n* Adults with impaired capacity to consent must have a Legally Authorized Representative (LAR) who is able to provide informed consent.\n\nEXCLUSION CRITERIA:\n\nParticipants will be unable to enroll if they:\n\n* Are unwilling or unable to cooperate with the study procedures.\n* Female participants of childbearing potential who are pregnant are not eligible for enrollment.",true,"ALL","2 Years","100 Years",{"count":22,"type":23},10000,"ESTIMATED","OBSERVATIONAL","This study will allow National Eye Institute (NEI) doctors the opportunity to examine people with eye disease, whether the diagnosis is known or not, to determine if they are eligible for other NEI research studies. No treatment is offered in this study.\n\nPeople of all ages with various eye conditions, including genetic conditions, eye movement disorders, inflammatory eye diseases, retinal diseases and external eye diseases, may be eligible for this study.\n\nParticipants undergo various tests and procedures to diagnose or evaluate their eye disease. The procedures may include the following:\n\n* Personal and family medical history\n* Physical examination and blood tests, including genetic testing.\n* Eye examination with dilation to measure visual acuity and eye pressure and to examine the front and back parts of the eye.\n* Questionnaire about vision and daily activities.\n* Conjunctival swab or lacrimal bland biopsy, or both: A sample of cells from the eyes is collected by swabbing the surface of the eye or by surgically removing a small sample of the surface of the eye or tear gland.\n* Electroretinogram to examine retinal function: The subject sits in the dark with his or her eyes patched for 30 minutes. The patches are removed, the surface of the eyes is numbed, and contact lenses that can sense signals from the retina are placed on the eyes. The subject then watches flashing lights.\n* Fluorescein angiography to examine the blood vessels in the eye: A dye is injected into a vein in the arm. The dye travels through the veins to the blood vessels in the eyes. A camera takes pictures of the dye as it flows through the blood vessels.\n* Optical coherence tomography to measure retinal thickness: A machine used to examine the eyes produces cross-sectional pictures of the retina.\n* Microperimetry to test how sensitive different parts of the retina are to changing levels of light. The subject sits in front of a computer and presses a button when he or she sees a light on the screen.\n* Oculography to record eye movements: Eye movements are measured by contact lenses or goggles that the subject wears while watching a series of spots on a computer screen.",[27],"Eye Diseases",[29,30,31],"Eye","Photograph","Retina","RECRUITING","2026-06-25",{"date":35,"type":36},"2026-06-26","ACTUAL",{"date":38,"type":36},"2008-08-20",{"name":40,"class":41},"National Eye Institute (NEI)","NIH",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":68,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100584599","phase-3-study-to-evaluate-sepofarsen-in-subjects-with-leber-congenital-amaurosis-lca-type-10-hyperion-100584599","NCT06891443","Study to Evaluate Sepofarsen in Subjects With Leber Congenital Amaurosis (LCA) Type 10 (HYPERION)","A Double-Masked, Randomized, Placebo-Controlled, Paired-Eye Study to Evaluate the Efficacy, Safety and Tolerability of Sepofarsen in Subjects With Leber Congenital Amaurosis (LCA) Due to the c.2991+1655A>G (p.Cys998X) Mutation in the CEP290 Gene","HYPERION","Inclusion Criteria:\n\n1. Confirmed clinical diagnosis of LCA10 and a molecular diagnosis of homozygosity or compound heterozygosity for the c.2991+1655A\\>G mutation in CEP290.\n2. Adults: \\>=18 years \u002F Minors: 6 to \\\u003C18 years.\n3. BCVA (FrACT) equal to or worse than logMAR +0.4 (approximate Snellen equivalent 20\u002F50) to +2.9 logMAR based on quantifiable, reliable FrACT. LP subjects with documented evidence of prior better vision eligible.\n4. Symmetrical disease between the two eyes as defined by a BCVA (FrACT) within 0.2 logMAR at baseline.\n5. Detectable ONL in the macular area as determined by the CRC at Screening.\n\nExclusion Criteria:\n\n1. Mutations in genes other than the CEP290 gene associated with other IRD diseases or syndromes.\n2. Presence of any ocular pathology in either eye that may make comparison of the eyes not feasible.\n3. Presence of unstable concurrent CME, or subject started on (or changed dose of) topical or systemic carbonic anhydrase inhibitor treatment in the 3 months prior to enrollment. CME is allowed if stable for 3 months (with or without treatment).\n4. Presence of any clinically significant lens opacities\u002Fcataracts based on the AREDS lens grading scale.\n5. Any prior receipt of genetic (RNA or DNA therapy) or stem-cell therapy for ocular or non-ocular disease, including sepofarsen.","6 Years",{"count":53,"type":23},32,"INTERVENTIONAL",[56],"PHASE3","The purpose of this double-masked, randomized, placebo-controlled, paired-eye study is to evaluate the efficacy, safety and tolerability of Sepofarsen in subjects with Leber Congenital Amaurosis (LCA) due to the c.2991+1655A\\>G (p.Cys998X) mutation in the CEP290.",[59,60,61,62,63,64,65,27,66,67],"Leber Congenital Amaurosis 10","Blindness","Leber Congenital Amaurosis","Sensation Disorders","Vision Disorder","Neurological Manifestations","Eye Diseases, Hereditary","Eye Disorders Congenital","Retinal Disease",[69,70,71,72,73,74,75,76,77],"LCA10","p.Cys998X","Antisense oligonucleotides","RNA therapy","QR-110","sepofarsen","CEP290","Leber's Congenital Amaurosis","c.2991+1655A>G","2026-06-24",{"date":33,"type":36},{"date":81,"type":36},"2025-06-04",{"date":83,"type":23},"2028-10",{"name":85,"class":86},"Laboratoires Thea","INDUSTRY",17,{"id":89,"slug":90,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":17,"sex":18,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":42},"100233485","adaptive-optics-retinal-imaging-100233485","NCT02317328","Adaptive Optics Retinal Imaging","* INCLUSION CRITERIA:\n\nParticipants will be eligible if they:\n\n* Are 12 years of age or older.\n* Have the ability to cooperate with an eye exam and adaptive optics imaging.\n* Have the ability to understand and sign an informed consent or have a parent\u002Flegal guardian to do so if they are minor children.\n* Have an eye disease or are a healthy volunteer with a normal eye exam (no visually-significant eye findings on examination).\n\nEXCLUSION CRITERIA:\n\nParticipants will not be eligible if:\n\n-They have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity).\n\nEXCLUSION CRITERIA FOR FLUORESCEIN AND\u002FOR INDOCYANINE GREEN IMAGING\n\nPartaicipants are not eligible for fluorescein and\u002For indocyanine green imaging if they:\n\n* Are under 18 years of age.\n* For participants who will undergo fluorescein imaging have a history of adverse reaction to fluorescein.\n* For participants who will undergo indocyanine green imaging have a history of adverse reaction to indocyanine green dye, know or suspected allergies to iodine or shellfish.","12 Years","120 Years",{"count":97,"type":23},1000,"Background:\n\n\\- By the time diseases of the retina are detected, serious damage has often already been done. Researchers want to find better ways of viewing the retina. One way called adaptive optics may help detect problems earlier.\n\nObjectives:\n\n\\- To study if adaptive optics can help find better ways to diagnose, treat, and manage retinal diseases.\n\nEligibility:\n\n* People over age 12 with an eye disease.\n* Healthy volunteers over age 12.\n\nDesign:\n\n* Participants will be screened with medical history and eye exams. These may include dilating pupils and taking pictures of the eyes.\n* Participants will have 1 or more study visits. They will have:\n* Medical and eye history.\n* Questions about their medications.\n* Eye exam including pupil dilation.\n* Adaptive optics imaging. After dilation, participants sit still while looking into an adaptive optics instrument. They look at specific places and images are taken of their retina.\n* They may also have:\n* More images.\n* Perimetry. Participants look into a lens and press a button when they see a light.\n* Color vision tests.\n* Electroretinogram. Participants will get numbing eye drops and special contact lenses. A small metal electrode will be put on their forehead. They will look at flashing lights and try not to blink.",[27,100],"Healthy Volunteers",[102,103],"Eye Disease","Natural History","2026-06-13",{"date":106,"type":36},"2026-06-16",{"date":108,"type":36},"2015-02-20",{"date":110,"type":23},"2028-03-31",{"name":40,"class":41},{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":17,"sex":18,"minAge":120,"maxAge":4,"enrollmentInfo":121,"targetDuration":123,"studyType":24,"phases":4,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":42},"100504665","the-proactive-ophthalmic-examination-cohort-100504665","NCT05851287","The Proactive Ophthalmic Examination Cohort","The Proactive Ophthalmic Examination Cohort of Older Adults","POEC","Inclusion Criteria:\n\n\\- Aged 65 years or older\n\nExclusion Criteria:\n\n* Unable to complete required systemic or ophthalmic examinations due to frailty, poor general health, or other physical limitations\n* Refusal to participate in the study","65 Years",{"count":122,"type":23},5000,"10 Years","The Proactive Ophthalmic Examination Cohort of Older Adults is a prospective cohort study recruiting community-dwelling older adults aged 65 years or older. Through comprehensive assessment of demographic profiles, medical histories, and ocular structural and functional parameters, alongside systematic collection of ophthalmic and systemic clinical data and biological specimens, we will establish a multidimensional, high-quality ocular health database encompassing demographic characteristics, socioeconomic factors, lifestyle variables, ocular disease risk factors, subjective ocular symptoms, objective examination findings, and biospecimens. The study will investigate the onset and progression patterns of ocular diseases, associated risk factors, and mechanisms of ocular aging in older populations, while simultaneously providing normal-controlled clinical and genomic data for other clinical studies on eye diseases. Furthermore, leveraging algorithmic innovation and artificial intelligence technologies, we will develop a personalized risk prediction and monitoring platform for age-related eye diseases, enhancing early screening and diagnostic capabilities and advancing precision medicine for ocular health in older adults.",[126,27],"Vision Impairment",[128,129,130,131,132],"older adults","eye health","cohort","risk factor","eye diseases","2026-06-08",{"date":135,"type":36},"2026-06-09",{"date":137,"type":36},"2023-02-20",{"date":139,"type":23},"2034-02-19",{"name":141,"class":142},"Zhongshan Ophthalmic Center, Sun Yat-sen University","OTHER",{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":18,"minAge":151,"maxAge":95,"enrollmentInfo":152,"targetDuration":4,"studyType":54,"phases":154,"briefSummary":155,"conditions":156,"keywords":159,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100413450","phase-3-vitrectomy-subretinal-tissue-plasminogen-activator-tpa-and-intravitreal-gas-for-submacular-haemorrhage-secondary-to-exudative-wet-age-related-macular-degeneration-tiger-100413450","NCT04663750","Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER).","Vitrectomy, Subretinal Tissue Plasminogen Activator and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative Age-Related Macular Degeneration (TIGER): a Phase 3, Pan-European, Two-group, Observer-masked, Superiority, Randomised Controlled Surgical Trial.","TIGER","Inclusion Criteria:\n\nGeneral\n\n1. Males or females aged at least 50 years\n\n   Study eye\n2. SMH, comprising sub-neuroretinal haemorrhage with or without sub-RPE haemorrhage, that occurs secondary to treatment naïve, or previously treated exudative AMD, including choroidal neovascularisation (CNV), idiopathic polypoidal choroidal vasculopathy (IPCV) and retinal angiomatous proliferation (RAP).\n3. SMH involving the foveal centre that measures at least 1 disc diameter in greatest linear dimension.\n4. Sub-neuroretinal haemorrhage at least 125 microns thick, measured at the foveal centre using spectral-domain optical coherence tomography (SD-OCT).\n5. BCVA between counting fingers and an Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score of 70, inclusive.\n\nExclusion Criteria:\n\nGeneral\n\n1. Serious allergy to fluorescein or indocyanine green (ICG).\n2. Hypersensitivity to alteplase, gentamicin, arginine, phosphoric acid, polysorbate 80 or aflibercept.\n3. Stroke, transient ischaemic attack or myocardial infarction within 6 months.\n4. Participation in another interventional study within 12 weeks of enrolment or planned to occur during this study.\n5. Women who are breast feeding, pregnant, or planning to become pregnant during the clinical trial. Any sexually active women of childbearing potential must agree continued abstinence from heterosexual intercourse or to use highly effective methods of birth control for the duration up to 12 weeks after administration of IMP or the last administration of aflibercept on the trial. Men must also agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy. Females of childbearing potential are females who have experienced menarche and are not surgically sterilised (e.g. hysterectomy or bilateral salpingectomy) or post-menopausal (defined as at least 1 year since last regular menstrual period). Highly effective methods of birth control are those with a failure rate of \\\u003C 1% per year when employed consistently and correctly, eg. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation via oral, intravaginal, and transdermal routes; progestogen-only hormonal contraception associated with inhibition of ovulation via oral, injectable, implantable, intrauterine device (IUD), or intrauterine hormone-releasing system ( IUS); or vasectomised partner.\n6. International Normalised Ratio (INR) greater than 3.5, unless it is anticipated that the INR can be brought below this level prior to vitrectomy, balancing the systemic risks with those of intraocular haemorrhage\\*.\n7. Unwilling, unable, or unlikely to return for scheduled follow-up for the duration of the trial.\n8. Any other condition which, in the opinion of the investigator, would prevent the participant from granting informed consent or complying with the protocol, such as dementia, mental illness, or serious systemic medical disease.\n\n   Study eye\n9. SMH that is known or estimated to have been present for longer than 15 days, as evidenced by history, pre-trial clinical documentation, or fundus appearance.\n10. SMH due to eye disease other than exudative AMD.\n11. Current active proliferative diabetic retinopathy.\n12. Current intraocular inflammation.\n13. Current ocular or periocular infection other than blepharitis.\n14. Current or known former high myopia (\\>6 dioptres).\n15. Aphakia.\n16. Other current or pre-existing ocular conditions that, in the opinion of the Investigator, will preclude any improvement in BCVA following resolution of SMH, such as severe central macular atrophy or fibrosis, dense amblyopia, macular hole involving the fovea, or very poor BCVA prior to presentation with SMH (counting fingers or worse).\n17. Inadequate pupillary dilation or significant media opacities, which will prevent adequate clinical evaluation of the posterior segment or fundus imaging.\n18. Intraocular surgery within 12 weeks of enrolment except for uncomplicated cataract surgery, which is permitted within 8 weeks of enrolment.\n\n    * Applies only to participants receiving warfarin.","50 Years",{"count":153,"type":23},210,[56],"The centre of the retina (macula) at the back of the eye contains cells that give us our central vision that we use for reading and recognising faces. These cells can be damaged by a disease called wet age-related macular degeneration (AMD), where new abnormal blood vessels grow through the macula and leak fluid. This can affect vision. In some cases, wet AMD can also cause a bleed under the macula, known as a submacular haemorrhage (SMH), which can lead to marked and persistent loss of vision in the eye.\n\nThe current standard treatment for wet AMD is to give injections containing 'anti-VEGF' drugs into the eye. Anti-VEGF drugs reduce the leakage of fluid so that the macula can become dry again and sight can improve.\n\nAnti-VEGFs are also the current standard of care for SMH, mainly because there is no licensed treatment for the SMH itself (patients with SMH were excluded from most wet AMD studies).\n\nThe purpose of this study therefore is to compare two treatments:\n\n1. Standard treatment for wet AMD (anti-VEGF injections).\n2. Standard treatment above plus surgery. This study will find out if having surgery alongside anti-VEGF injections can improve vision further over the current standard treatment of anti-VEGF injections alone.",[27,157,158],"Macular Degeneration, Wet","Sub-Macular Hemorrhage",[157,158],"2026-05-13",{"date":162,"type":36},"2026-05-15",{"date":164,"type":36},"2021-04-16",{"date":166,"type":23},"2028-12",{"name":168,"class":142},"King's College Hospital NHS Trust",36,{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":18,"minAge":176,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":54,"phases":180,"briefSummary":182,"conditions":183,"keywords":186,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":42},"100380391","the-role-of-transscleral-cyclophotocoagulation-in-patients-undergoing-a-boston-keratoprosthesis-100380391","NCT04232982","The Role of Transscleral Cyclophotocoagulation in Patients Undergoing a Boston Keratoprosthesis","Inclusion Criteria:\n\n* Adults patients\n* Able to give an informed consent\n* Capable of being followed during the study\n* Candidate for the Boston keratoprosthesis type I\n\nExclusion Criteria:\n\n* Patients younger than 18 years old or older than 80 years old\n* Unable to give an informed consent\n* Participating to another interventional glaucoma study\n* Patients who received a glaucoma surgery or procedure (glaucoma drainage device or TS-CPC treatment) 3 months before their initial visit.\n* Unable to wear a therapeutic contact lens secondary to eyelid malformation\n* Severe Ocular surface Disease with keratinization\n* Intra-ocular tumor\n* Terminal Glaucoma\n* Phthisis bulbi\n* Ocular albinism","18 Years","80 Years",{"count":179,"type":23},20,[181],"NA","The Boston keratoprosthesis (KPro) is a special plastic device that is used to replace a sick cornea (transparent part of the eye, in front of the iris) in order to restore vision in patients who have failed traditional corneal transplants or have a very poor prognosis of success.\n\nGlaucoma is a chronic disease which causes optic nerve damage secondary to high pressure inside the eye and could lead to vision loss in the long term. Glaucoma is highly prevalent in patients who require a KPro and even more after their procedure.\n\nIn order to decrease the intra-ocular pressure, surgeons can use multiple eyedrops. Unfortunately, following the KPro surgery, eyedrops lose their efficiency because they are less absorbed by the eye.\n\nThe transscleral cyclophotocoagulation (TS-CPC) is a laser treatment used in advanced refractory glaucoma. This laser helps decrease the intra-ocular pressure and have a better control of the disease. There are different methods of laser transmission, including the continuous transmission (G-Probe) and the micro-pulsation method (Micopulse). Given the high prevalence of glaucoma in patients receiving a KPro, the investigators are studying the effect of giving the TS-CPC treatment prophylactically to patients before their Boston keratoprosthesis.\n\nOur hypothesis is that prophylactic TS-CPC will decrease glaucoma progression as well as the risks of developing glaucoma following the Boston keratoprosthesis .\n\nMETHOD The investigators aim to recruit twenty (20) patients who are scheduled to receive Boston KPro. Participants will be randomized into two groups: 1) Groupe 1 will receive a prophylactic treatment of transscleral cyclophotocoagulation a G-Probe. 2) Groupe 2 will receive a prophylactic treatment of transscleral cyclophotocoagulation with a micropulse transmission (MicroPulse). The patients will receive their laser treatment by a glaucoma specialist 4 to 8 weeks before their KPro surgery. One week following their laser treatment, the participants will be examined by their glaucoma specialist.\n\nFollowing their KPro surgery, patients will have a follow-up at day-1, weeks 1 and 2, months 1 and 3, then every 4 to 6 months for 5 years. Additional non-invasive glaucoma tests will be performed twice during the first 3 months following the surgery and will be repeated every 4-6 months. Visual acuity results, the visual field tests and rates of post-operative complications will be compared between the different groups.",[184,27,185],"Glaucoma","Cornea Disease",[187,188,189,190],"Boston keratoprosthesis","Transscleral cyclophotocoagulation","Micropulse transscleral cyclophotocoagulation","G-Probe Transscleral cyclophotocoagulation","2026-04-23",{"date":193,"type":36},"2026-04-27",{"date":195,"type":36},"2020-01-30",{"date":197,"type":23},"2036-12-01",{"name":199,"class":142},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":18,"minAge":208,"maxAge":20,"enrollmentInfo":209,"targetDuration":211,"studyType":24,"phases":4,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":42},"100610531","natural-history-study-of-patients-with-eys-associated-rp-100610531","NCT07228793","Natural History Study of Patients With EYS-Associated RP","Natural History Prospective Open Clinical and Genetic Study of Patients With EYS-Associated Retinitis Pigmentosa","RUS_EYS","Inclusion Criteria:\n\n1. Willing to participate in the study and able to communicate consent during the consent process\n2. Ability to return for all study visits over 48 months\n3. Age ≥ 18 years\n4. Must meet one of the Genetic Screening Criteria, defined below:\n\nScreening Group A: At least 2 disease-causing variants in the EYS gene which are homozygous or heterozygous in trans, based on a report from a clinically-certified lab (or a report from a research lab that has been pre-approved by the Study Committee) Screening Group B: Only 1 disease-causing variant in the EYS gene, based on a report from a clinically-certified lab (or a report from a research lab which has been pre-approved by the Study Committee) Screening Group C: At least 2 disease-causing variants in the EYS gene which are unknown phase, based on a report from a clinically-certified lab (or a report from a research lab which has been pre-approved by the Study Committee) Note pertaining to all Screening Groups: if a participant has a variant(s) of unknown significance, he\u002Fshe would still qualify as long as there is at least 1 disease-causing variant(s) on the EYS gene.\n\nOcular Inclusion Criteria:\n\nBoth eyes must meet all of the following:\n\n1. Clinical diagnosis of retinal dystrophy\n2. Clear ocular media and adequate pupil dilation to permit good quality photographic imaging\n\nExclusion Criteria:\n\n1. Mutations in genes that cause autosomal dominant retinitis pigmentosa (ADRP), X-linked retinitis pigmentosa (RP), or presence of biallelic mutations in autosomal recessive RP\u002Fretinal dystrophy genes other than EYS.\n2. Expected to enter experimental treatment trial at any time during this study\n3. History of more than 1 year of cumulative treatment, at any time, with an agent associated with pigmentary retinopathy (including hydroxychloroquine, chloroquine, thioridazine, and deferoxamine)\n\nOcular exclusion Criteria:\n\nIf either eye has any of the following, the participant is not eligible:\n\n* Current vitreous hemorrhage\n* Current or any history of rhegmatogenous retinal detachment\n* Current or any history of (e.g., prior to cataract or refractive surgery) spherical equivalent of the refractive error worse than -8 Diopters of myopia\n* History of intraocular surgery (e.g., cataract surgery, vitrectomy, penetrating keratoplasty, or LASIK) within the last 3 months\n* Current or any history of confirmed diagnosis of glaucoma (e.g., based on glaucomatous visual functions changes or nerve changes, or history of glaucoma filtering surgery)\n* Current or any history of retinal vascular occlusion or proliferative diabetic retinopathy\n* History or current evidence of ocular disease that, in the opinion of the investigator, may confound assessment of visual function\n* History or evidence of active treatment for retinitis pigmentosa that could affect the progression of retinal degeneration, including:\n* Any use of ocular stem cell or gene therapy\n* Treatment with an ophthalmic oligonucleotide within the last 9 months (last treatment date is less than 9 months prior to Screening Visit date)\n* Treatment with any other product within five times the expected half-life of the product (time from last treatment date to Screening Visit date is at least 5 times the half-life of the given product)","14 Years",{"count":210,"type":23},45,"5 Years","This natural history study of patients with EYS mutations from Russia and former CIS (Commonwealth of Independent States) territories will accelerate the development of outcome measures for clinical trials. Sensitive, reliable outcome measures of retinal degeneration will greatly facilitate development of treatments for retinitis pigmentosa due to EYS mutations. This approach helps to develop experimental treatment protocol, and assessing its effectiveness.\n\nThe goals and expected impact of this natural history study are to:\n\n1. Describe the natural history of retinal degeneration in patients with biallelic mutations in EYS gene in Russia and former CIS territories.\n2. Identify sensitive structural and functional outcome measures to use for future multicenter clinical trials in EYS-related retinal degeneration in Russia and former CIS territories.\n3. Identify well-defined subpopulations for future clinical trials of investigative treatments for EYS-related retinal degeneration in Russia and former CIS territories.",[214,27],"Retinitis Pigmentosa",[216,217,218],"EYS mutation","RP","Retinitis pigmentosa","2026-04-22",{"date":221,"type":36},"2026-04-28",{"date":223,"type":36},"2025-11-07",{"date":225,"type":23},"2030-03-30",{"name":227,"class":86},"Sensor Technology for Deafblind",{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":18,"minAge":176,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":54,"phases":236,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":242,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":42},"100624710","phase-2-autologous-serum-tears-with-hyaluronate-vs-balanced-salt-solution-for-moderate-to-severe-dry-eye-100624710","NCT07413172","Autologous Serum Tears With Hyaluronate vs Balanced Salt Solution for Moderate-to-Severe Dry Eye","The Effect of Autologous Serum Tears Diluted to 50% With 0.2% Sodium Hyaluronate-Containing Preservative-Free Artificial Tears Versus Autologous Serum Tears Diluted to 50% With Balanced Salt Solution in Patients With Moderate-to-Severe Dry Eye Disease: A Prospective, Double-Blind, Randomized, Controlled, Contralateral-Eye Study","Inclusion Criteria:\n\n* Age ≥ 18 years old\n\n  * Formal diagnosis of one of the following conditions associated with aqueous-deficient dry eye disease: Sjögren's syndrome (primary or secondary), Mucous membrane pemphigoid, Graft-versus-host disease, Stevens-Johnson syndrome, Post-radiation lacrimal gland aqueous deficiency, or Neurotrophic keratitis\n  * Moderate-to-severe Dry Eye Disease (DED) symptoms for at least 6 months prior to study enrollment.\n  * OSDI score ≥ 25 and\u002For and OSDI-6 score \\> 6 at the screening visit\n  * Presence of at least two of the following clinical signs in the same eye, at the screening visit: Anesthetized Schirmer's test score 7 ≤ mm at 5 minutes, Tear Break up Time (TBUT) ≤ 7 seconds, Corneal fluorescein staining score ≥ 4 (maximum 15) as assessed by the National Eye Institute (NEI) grading scale 25, or Conjunctival lissamine green staining ≥ 3 (maximum 18) as assessed by the NEI grading scale\n  * Desire to use autologous serum tears at least twice daily in the 2 weeks prior to screening visit.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years old.\n\n  * Cognitive impairment or psychiatric condition that precludes informed consent or the ability to comply with study procedures.\n  * Any clinical condition identified at screening that, in the opinion of the treating physician, is clinically significant and would contraindicate safe participation in the study.\n  * Any condition or treatment known to affect the signs and symptoms of DED, including pregnancy, regular use of contact lenses, recent diagnosis of ocular allergy, infection, or inflammation, or recent ocular surgery within 6 months.\n  * Patients with stable ocular surface disease or neurotrophic keratitis secondary to prior ocular surgery, chronic glaucoma therapy, or eyelid abnormalities may be included.",{"count":179,"type":23},[237],"PHASE2","This study aims to find out whether adding sodium hyaluronate, a moisturizing ingredient commonly found in artificial tears, makes autologous serum eye drops more effective for treating moderate-to-severe dry eye disease. Each participant will use one version of the drops in one eye and the standard version in the other eye. The goal is to see if the new combination provides better relief, comfort, and eye surface healing compared to the traditional formulation.",[240,27,241],"Dry Eye","Eyes Dry Chronic","NOT_YET_RECRUITING","2026-04-15",{"date":245,"type":36},"2026-04-17",{"date":247,"type":23},"2026-07",{"date":249,"type":23},"2028-07",{"name":251,"class":142},"University of Miami",{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":18,"minAge":176,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":54,"phases":260,"briefSummary":261,"conditions":262,"keywords":265,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":279},"100617721","restore-comparing-two-approaches-to-repeat-tt-surgery-performed-by-integrated-eye-care-workers-iecws-100617721","NCT07322302","RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)","Repeat Eyelid Surgery for Trichiasis: Optimizing Results in East Africa (RESTORE): A Randomized Controlled Trial Comparing Two Surgical Techniques for Repeat Trichiasis Surgery Performed by Integrated Eye Care Workers","Inclusion Criteria:\n\n* One or both eyes with upper eyelid PTT, with a plan to undergo PTT surgery\n* Previous upper eyelid TT surgery in the study eye(s)\n* Collection of all baseline data prior to randomization\n* Signed, informed consent\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* All eyes with previously operated trichiasis that are phthisical",{"count":97,"type":23},[181],"The primary objective of this randomized clinical trial is to determine whether repeat trichiasis surgery performed with Bevel-Rotate Advancement Procedure (B-RAP) improves surgical success compared to Bilamellar Tarsal Rotation (BLTR) among a group of 8-10 TT surgeons in Tanzania. The study aims to enroll 1,000 individuals with PTT. The primary outcome is repeat PTT within one year after surgery. Additionally, the study will assess eyelid contour abnormalities and how they change over a two-year period as well as patient reported outcomes.\n\nIf this project is successful in improving surgical outcomes, it could change the approach to treating PTT globally. Individuals with trichiasis have a significantly reduced quality of life; correcting their trichiasis long-term has the potential to improve their quality of life and their family members' quality of life considerably.",[263,27,264],"Trachoma","Trichiasis",[266,267,268,269],"Surgery","Oculoplastics","trichiasis","trachoma","2026-04-09",{"date":272,"type":36},"2026-04-13",{"date":274,"type":36},"2026-01-13",{"date":276,"type":23},"2029-08-31",{"name":278,"class":142},"University of North Carolina, Chapel Hill",2,{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":17,"sex":18,"minAge":286,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":54,"phases":289,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":299,"leadSponsor":301,"locationsCount":42},"100580766","advancing-pediatric-retinal-imaging-with-auto-aligned-oct-100580766","NCT06841575","Advancing Pediatric Retinal Imaging With Auto-aligned OCT","Inclusion Criteria:\n\n* Group 1: Healthy adult volunteers\n* Subject is able and willing to consent to study participation\n* Subject is more than 18 years of age\n* Healthy adult volunteers without known ocular issues other than refractive error\n* Group 2: Adult patients in ophthalmology clinics\n* Health care provider, knowledgeable of protocol, agrees that study personnel could contact the subject\n* Subject is able and willing to consent to study participation\n* Subject is more than 18 years of age and is a patient in the Duke Eye Center ophthalmology clinics\n* Group 3: Pediatric participants in ophthalmology clinics\n* Health care provider, knowledgeable of protocol, agrees that study personnel could contact the parent\u002Flegal guardian\n* Parent\u002Flegal guardian is able and willing to consent to study participation\n* Pediatric patient less than 18 years of age in Duke Eye Center ophthalmology clinics or undergoing clinically-indicated examination under anesthesia at Duke Eye Center\n\nExclusion Criteria:\n\n* Group 1: Healthy adult volunteers\n* Students or employees under direct supervision of the investigators\n* Subjects with prior problems with pupil dilation\n* Pregnant woman if receiving dilating drops\n* Group 2: Adult patients in ophthalmology clinics\n* Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)\n* Group 3: Pediatric participants in ophthalmology clinics\n* Parent\u002Flegal guardian unwilling or unable to provide consent\n* Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)","1 Month",{"count":288,"type":23},50,[181],"The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.",[27,67,184,292],"Optic Nerve Diseases",[294],"Optical Coherence Tomography (OCT)","2026-03-23",{"date":297,"type":36},"2026-03-25",{"date":295,"type":36},{"date":300,"type":23},"2027-09",{"name":302,"class":142},"Duke University",{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":17,"sex":18,"minAge":176,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":42},"100471140","assessment-of-the-ocular-microbiome-in-health-and-disease-100471140","NCT05414994","Assessment of the Ocular Microbiome in Health and Disease","Inclusion Criteria:\n\nWe will include subjects who meet all of the following criteria:\n\n* 18 years of age or older\n* Provide informed consent\n* Cohort A - normal eyes with no ocular disease\n* Cohort B - primary open angle glaucoma\u002FOcular hypertension defined as mild glaucoma which is well controlled with no more than one drop of prostaglandin use daily for the past 6 months\n* Cohort C - non-infectious keratopathy not using any prescription medication (OTC artificial tears are acceptable)\n* Cohort D - Dry AMD (age related macular degeneration)\n* Cohort E - Wet AMD\n* Cohort F - diabetic retinopathy\n\nExclusion Criteria:\n\nWe will exclude subjects who meet all of the following criteria:\n\n* Prior ocular disease either of the anterior or posterior segment\n* Any medical comorbidities except well controlled DH and HTN\n* Unable to follow up with study procedures as described",{"count":310,"type":23},500,"The objective of this application is to illustrate the core constituents of the ocular surface microbiome, describe factors that promote colonization, and assess the ocular microbiome's role in the health of the anterior segment. We will conduct a prospective, observational cohort study, including a longitudinal analysis of the ocular microbiome in adults.",[313,27,314],"Microbial Colonization","Ophthalmopathy","2026-01-19",{"date":317,"type":36},"2026-01-22",{"date":319,"type":36},"2023-09-07",{"date":321,"type":23},"2027-12-30",{"name":323,"class":142},"Vanderbilt University Medical Center",{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":18,"minAge":151,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":54,"phases":333,"briefSummary":334,"conditions":335,"keywords":340,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":42},"100606371","phase-2-sglt2-inhibitors-in-geographic-atrophy-100606371","NCT07174687","SGLT2 Inhibitors in Geographic Atrophy","Efficacy of Dapagliflozin in the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration","Inclusion Criteria:\n\n1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol\n2. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n3. Participant is male or, if female, participant is surgically sterilized or amenorrheic for at least one year\n4. ≥50 years old\n5. Evidence of dry advanced AMD with the presence of non-foveal Geographic Atrophy (GA)\n\n   1. The geographic atrophy must not involve the center point of the fovea.\n   2. Total area of geographic atrophy must be between 2.5 mm2 and 17.5 mm2 (1 - 4 disc areas, respectively).\n   3. If the geographic atrophy consists of multiple lesions, at least one lesion must have an area of ≥1.25 mm² (equivalent to 0.5 disc areas).\n6. BCVA between 20\u002F25 and 20\u002F320\n7. Must be treatment-naïve for AMD, except for oral supplements\n\nExclusion Criteria:\n\n1. Prior investigational drug use within 60 days\n2. Use of other SGLT2 inhibitors\n3. History of symptomatic hypotension or symptomatic hypotension (symptoms of hypotension + SBP \\\u003C 90mmHg) at baseline\n4. Type I and Type II Diabetes Mellitus\n5. End stage renal disease or estimated glomerular filtration rate less than 25 mL\u002Fmin\u002F1.73 m2 per MDRD calculation\n6. History of heart failure\n7. History of a serious hypersensitivity reaction to dapagliflozin or any of the excipients in FARXIGA\n8. Other concomitant disease or condition that investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral, or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures\n9. Any prior treatment for AMD (dry or wet) or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins or mineral\n10. Any intraocular surgery or thermal laser within 3 months of date of randomization\n11. Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks\n12. Any prior thermal laser in the macular region, regardless of indication (self-report)\n13. Any evidence of choroidal neovascularization in study eye\n14. Enrollment in another interventional trial during the trial period",{"count":332,"type":23},70,[237],"AMD is a leading cause of blindness in individuals over 50 years old, with dry AMD being the most common form. Geographic atrophy (GA) is an advanced stage of dry AMD characterized by progressive retinal cell degeneration. The primary objectives of the study are to assess the safety, tolerability, and evidence of activity of SGLT2 inhibitors in subjects with Geographic Atrophy associated with AMD.",[336,337,27,338,339],"Retinal Degeneration","Retinal Diseases","Geographic Atrophy","Pathological Conditions, Anatomical",[341,342,343,344,345],"Geographic Atrophy (GA)","Age-related Macular Degeneration","AMD","SGLT2","Dapagliflozin","2025-12-16",{"date":348,"type":36},"2025-12-18",{"date":350,"type":36},"2025-12-02",{"date":352,"type":23},"2028-06",{"name":354,"class":142},"Washington University School of Medicine",{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":18,"minAge":176,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":54,"phases":365,"briefSummary":366,"conditions":367,"keywords":369,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":42},"100587914","michigan-screening-and-intervention-for-glaucoma-and-eye-health-through-telemedicine-sight-2-100587914","NCT06934577","Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (SIGHT) 2","Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine- SIGHT 2: A Pragmatic Randomized Trial","SIGHT","Inclusion Criteria:\n\n• Speak English, Spanish, Arabic, Chinese, French, Hindi, Finnish, Albanian, Russian or Tagalog\n\nExclusion Criteria:\n\n* significant eye pain\n* sudden decrease in vision within one week\n* binocular diplopia\n* cognitive impairment\n* pregnancy\n* previously declined participation",{"count":364,"type":23},900,[181],"To compare eye disease detection rates at a Federally Qualified Health Center between a technology-enhanced protocol and standard optometric clinical examination for three of the leading causes of blindness: glaucoma, diabetic retinopathy, and visually significant cataract.",[27,368,184],"Visual Impairment",[370,371],"Eye disease screening","Glaucoma detection","2025-12-12",{"date":374,"type":36},"2025-12-15",{"date":376,"type":36},"2025-12-04",{"date":378,"type":23},"2030-08",{"name":380,"class":142},"University of Michigan",{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":12,"sex":18,"minAge":176,"maxAge":388,"enrollmentInfo":389,"targetDuration":4,"studyType":54,"phases":391,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":242,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":401,"leadSponsor":403,"locationsCount":4},"100613506","phase-4-switching-from-xiidra-to-tryptyr-100613506","NCT07267481","Switching From Xiidra to TRYPTYR","Efficacy of Switching Participants Treated With Xiidra to TRYPTYR","Inclusion Criteria:\n\n* Adults ≥18 years of age.\n* Have a history of DED for at least the past 6 months.\n* Are currently using Xiidra as directed by their eye care provider for ≥1 month.\n* Are symptomatic as determined with SPEED (≥7) and have an abnormal Schirmer test score \\[≥2 to \\\u003C10 mm\u002F5 min\\]) at Screening\u002FBaseline. If Shirmer only qualifies for one eye, that will be the study eye. If Shirmer qualifies for both eyes, the right eye will be the study eye.\n* Have corrected distance visual acuity of 20\u002F40 or better.\n* Willing to discontinue contact lens wear 24 hours prior to screening visit and throughout the study.\n\nExclusion Criteria:\n\n* Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).\n* Have a history of ocular surgery within the past 12 months.\n* Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related.\n* Punctal plugs in place for \\\u003C 3 months and\u002For Lacrifill in place for \\> 5 months.\n* Have ever used Accutane\n* Currently using ocular medications, including topical anti-inflammatory drops, (other than Xiidra) 1 month prior to enrollment\n* Any artificial tear use at enrollment must remain consistent throughout the study.\n* Are pregnant or breast feeding.\n* Have had a physical meibomian gland treatment withing 1 month of enrollment.\n* Initiated, discontinued or changed dose of a systemic medication known to cause ocular drying (e.g., antihistamines or tricyclic antidepressants) within 14 days of the screening visit.\n* Have a condition or be in a situation, which in the investigator's opinion, may put the participant at significant risk, may confound the results, or may significantly interfere with their study participation.","99 Years",{"count":390,"type":23},100,[392],"PHASE4","To determine the efficacy of switching participants who are being treated with Xiidra to acoltremon 0.003%.\n\nHypothesis: Switching to acoltremon 0.003% will greatly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline.",[240,395,396,27],"Dry Eyes Chronic","Dry Eye Syndromes","2025-11-25",{"date":399,"type":36},"2025-12-05",{"date":374,"type":23},{"date":402,"type":23},"2026-05-01",{"name":404,"class":142},"Southern College of Optometry",{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":18,"minAge":176,"maxAge":413,"enrollmentInfo":414,"targetDuration":4,"studyType":54,"phases":416,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":425},"100613465","phase-4-impact-of-tryptyr-on-a-patients-quality-of-life-and-ability-to-perform-work-100613465","NCT07266948","Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work","Evaluating the Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work","TRYPTYR ADL","Inclusion Criteria:\n\n* Adults ≥18 years of age.\n* Have a history of DED for at least the past 6 months.\n* Are currently using Restasis as directed by their eye care provider for ≥1 month.\n* Participant intends to stop Restasis in the near future because and expressed dissatisfaction with effectiveness of Restasis in reducing dry eye symptoms..\n* Are symptomatic as determined with the Eye Dryness visual analog scale (VAS) (Score ≥50), SPEED (≥7), and have an abnormal Schirmer test score \\[≥2 to \\\u003C10 mm\u002F5 min\\]) at Screening\u002FBaseline.\n* Have corrected distance visual acuity of 20\u002F100 or better.\n* Willing to discontinue contact lens wear throughout the study.\n\nExclusion Criteria:\n\n* Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).\n* Have a history of ocular surgery within the past 12 months.\n* Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related.\n* Punctal plugs in place for \\\u003C 3 months and\u002For Lacrifill in place for \\> 5 months.\n* Have ever used Accutane or are currently using ocular medications (must washout from all dry eye medications\u002Ftreatments at least 1 week before entry, except for Restasis).\n* Use of artificial tears within 2 hours prior to the baseline visit or during the study.\n* Are pregnant or breast feeding.\n* Have had a physical meibomian gland treatment withing 1 month of enrollment.\n* Have a condition or be in a situation, which in the investigator's opinion, may put the participant at significant risk, may confound the results, or may significantly interfere with their study participation.","75 Years",{"count":415,"type":23},40,[392],"This 1-month, 3-visit study will be conducted at the Southern College of Optometry (Memphis, TN), Kannarr Eye Care, LLC (Pittsburg, KS) and Complete Eye Care of Medina (Minneapolis, MN). Adults ≥18 years of age who have been diagnosed with DED for at least 6 months and who are currently symptomatic (Eye Dryness VAS Score ≥40) will be recruited. Subjects will have an abnormal Schirmer test of \\\u003C10 mm\u002F5 min. Subjects will also be required to score ≤70 on the IDEEL Quality of Life (QoL) Work domain to ensure that their DED symptoms are significantly impacting their ability to do work.9 Subjects will be required to have corrected distance visual acuity of 20\u002F32 (0.2 logMAR) or better.",[240,27,241],{"date":399,"type":36},{"date":421,"type":36},"2025-11-01",{"date":423,"type":23},"2026-03-01",{"name":404,"class":142},3,{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":18,"minAge":176,"maxAge":20,"enrollmentInfo":432,"targetDuration":4,"studyType":54,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":242,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":441,"locationsCount":4},"100613492","phase-4-switching-from-restasis-to-tryptyr-100613492","NCT07267299","Switching From Restasis to TRYPTYR","Efficacy of Switching Participants Treated With Restasis to TRYPTYR",{"count":390,"type":23},[392],"Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Restasis at 28 days post-treatment compared to baseline. Dry eye disease (DED) is a prevalent condition that commonly affects patients of working age in addition to the elderly. DED is a complex condition that results in ocular symptoms such as dryness and burning and signs such as decreased tear production (aqueous deficient DED) or increased tear evaporation (evaporative DED). Unfortunately, there is not a perfect correlation between DED signs and symptoms, which makes diagnosis and timely treatment challenging.",[240,27,436],"Chronic Dry Eye",{"date":399,"type":36},{"date":439,"type":23},"2025-12-01",{"date":162,"type":23},{"name":404,"class":142},{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":446,"acronym":447,"eligibilityCriteria":448,"healthyVolunteers":17,"sex":18,"minAge":449,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":452,"conditions":453,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":42},"100529735","widefield-confocal-scanning-laser-ophthalmoscope-optimized-for-pediatric-and-neonatal-imaging-100529735","NCT06177639","Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging","WiSLO","Inclusion Criteria:\n\n* Adults (≥18 years) that may or may not have eye pathology\n* Infant\u002Fchild undergoing clinically-indicated examination that may or may not have eye pathology. NOTE: We will not enroll inpatient pre-term infants or neonates. The youngest age at enrollment will be 30 days adjusted age using the NICH NRN Web-based Adjusted Age Calculator.\n* Adults and infant\u002Fchild with or without prior pupil dilation for clinical eye care visit\n* Adult participant is able and willing to consent to study participation\n* Parent\u002FLegal Guardian is able and willing to consent to study participation for the minor\n* Pediatric participant \\>12 years is able and willing to assent to study participation\n\nExclusion Criteria:\n\n* Participant or Parent\u002FLegal Guardian unwilling or unable to provide consent\n* Participant has a health or eye condition that would preclude eye examination or retinal imaging (e.g. evidence of inflammation or infection of ocular surface or eyelids, or corneal opacity or cataract)","30 Days",{"count":451,"type":23},42,"The goal of this observational study is to test the use of a novel Widefield Confocal Scanning Laser Ophthalmoscope (WiSLO) Optimized for Pediatric and Neonatal Imaging in pediatric and adult subjects who are undergoing clinical evaluation for eye disease or are healthy adult volunteers.\n\nThe main questions to answer are:\n\n* Whether WiSLO will be more comfortable and satisfactory in experience for the patient and operator than commercial alternatives.\n* If the quality of WiSLO near infrared images will be comparable to color fundus camera imaging across population of different ages and fundus pigmentation.\n\nParticipants will have the following research procedures:\n\n* Imaging of both eyes with a research noncontact WiSLO\n* Imaging of both eyes with a commercially available non-contact hand held fundus camera (Volk Pictor Plus)\n* Likert scales for adults\n* Pediatric Likert scales for children\n* CRIES scales for infants.",[27],"2025-10-06",{"date":456,"type":36},"2025-10-08",{"date":458,"type":36},"2025-10-01",{"date":460,"type":23},"2026-08",{"name":302,"class":142},{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":54,"phases":470,"briefSummary":472,"conditions":473,"keywords":478,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":279},"100450608","phase-1-safety-of-cultured-allogeneic-adult-umbilical-cord-derived-mesenchymal-stem-cells-for-naion-100450608","NCT05147701","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for NAION","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Non-arteritic Ischemic Optic Neuropathy","Inclusion Criteria:\n\n* Diagnosis of NAION (non-arteritic ischemic optic neuropathy)\n* Understanding and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Active infection\n* Active cancer\n* Chronic multisystem organ failure\n* Pregnancy\n* Clinically significant Abnormalities on pre-treatment laboratory evaluation\n* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.\n* Continued drug abuse\n* Pre-menopausal women not using contraception\n* Previous organ transplant\n* Hypersensitivity to sulfur",{"count":179,"type":23},[471],"PHASE1","This trial will study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of non-arteritic ischemic optic neuropathy",[27,214,474,475,476,477],"Diabetic Retinopathy","Macular Degeneration","Traumatic Optic Neuropathy","Optic Atrophy",[27,214,479,474,475,476,477],"stem cell treatment","2025-04-15",{"date":482,"type":36},"2025-04-17",{"date":484,"type":36},"2022-02-01",{"date":486,"type":23},"2026-01",{"name":488,"class":142},"The Foundation for Orthopaedics and Regenerative Medicine",{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":18,"minAge":176,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":54,"phases":498,"briefSummary":499,"conditions":500,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":279},"100524715","phase-2-extension-study-of-two-doses-of-linsitinib-in-subjects-with-active-moderate-to-severe-thyroid-eye-disease-ted-100524715","NCT06112340","Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)","A Multicenter, Extension Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)","Inclusion Criteria:\n\n* Subject who completed the 24-week double-mask period of VGN-TED-301 and are proptosis non-responders (\\\u003C 2 mm reduction in proptosis in the study eye) at Week 24 of VGN-TED-301 study or proptosis responders at Week 24 who relapse during the Follow-Up period of VGN-TED-301\n* Subject has not received any treatment for TED since Week 24 of VGN-TED-301\n* Subjects must be euthyroid with the participant's baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine \\[FT4\\] and free triiodothyronine levels \\[FT3\\] \\\u003C50% above or below the normal limits) at Baseline. Every effort should be made to correct mild hypo- or hyperthyroidism promptly and maintain the euthyroid state for the duration of the clinical trial\n* Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Baseline and is not planning for any such treatment during the course of the study\n\nExclusion Criteria:\n\n* The exclusion criteria of protocol VGN-TED-301 also apply to this extension study.",{"count":497,"type":23},75,[237,56],"The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.",[501,502,503,27,504,505,506,507,508,509,510,511],"Thyroid Eye Disease","Graves Orbitopathy","Endocrine System Diseases","Thyroid Associated Ophthalmopathy","Graves Ophthalmopathy","Thyroid Diseases","Orbital Diseases","Proptosis","IGF1R","Exophthalmos","Hashimoto","2025-02-24",{"date":514,"type":36},"2025-02-25",{"date":516,"type":36},"2023-10-11",{"date":518,"type":23},"2026-06",{"name":520,"class":86},"Sling Therapeutics, Inc.",{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":527,"targetDuration":529,"studyType":24,"phases":4,"briefSummary":530,"conditions":531,"keywords":532,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":42},"100578557","patterns-of-eye-diseases-among-patients-attending-the-eye-investigation-unit-of-sohag-university-hospital-100578557","NCT06812845","Patterns of Eye Diseases Among Patients Attending The Eye Investigation Unit of Sohag University Hospital","Inclusion Criteria:\n\n\\- All patients referred to the eye investigation unit from the outpatient clinic of Sohag university hospital, private clinics or health insurance.\n\nExclusion Criteria:\n\n* Patients unable to measure visual acuity.\n* Patients unable to measure intraocular pressure.\n* Mentally retarded patients.\n* Undiagnosed patients.",{"count":528,"type":23},7000,"1 Year","The goal of the work: is to assess the patterns of eye diseases in patients attending the eye investigation unit of Sohag University Hospital.organize the community education. The main question it aims to answer is\n\n* DOES eye disease blindness prevalence rate increase in women more than men?\n* What is the rate of glaucoma and other ocular diseases that causes irreversible blindness among the attending patients? Patients attending to the eye investigation unit of Sohag University Hospital in the period from January 2025 to December 2025 are being observed in this work to determine the eye diseases prevalence.",[27],[533],"patterns of eye disease","2025-02-08",{"date":536,"type":36},"2025-02-12",{"date":538,"type":36},"2025-01-01",{"date":540,"type":23},"2026-06-30",{"name":542,"class":142},"Sohag University",{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":18,"minAge":208,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":54,"phases":551,"briefSummary":552,"conditions":553,"keywords":556,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":565,"locationsCount":42},"100562279","phase-3-effects-of-topical-insulin-on-corneal-epithelium-healing-after-corneal-crosslinking-in-patients-with-keratoconus-100562279","NCT06601101","Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus","Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Patients with a diagnosis of keratoconus, indicated for corneal crosslinking\n\nExclusion Criteria:\n\n* Diabetes Mellitus\n* Severe dry eye\n* Limbal Stem Cell Deficiency\n* Glaucoma\n* Insulin or methylcellulose allergy",{"count":169,"type":23},[56],"The cornea plays a fundamental role in vision, being a complex tissue essential for ocular health. In ophthalmological practice, there are situations such as corneal crosslinking, where damage to the corneal epithelium occurs. Crosslinking is a surgical procedure aimed at strengthening collagen bonds in the corneal stroma to prevent the progression of keratoconus, through the application of topical riboflavin followed by ultraviolet (UV-A) radiation. To enhance the effectiveness of riboflavin and UV-A radiation, the corneal epithelium needs to be removed, which can cause postoperative pain and discomfort, as well as increase the risk of complications such as infections, scarring, corneal opacities, perforations, and recurrent epithelial erosions. Several growth factors play a role in epithelial healing, and the discovery of insulin in the tear film and the presence of insulin and Insulin-Like Growth Factor (IGF-1) receptors in the cornea has raised the hypothesis that insulin may modulate the cornea's wound healing response. Since then, topical insulin has been used for various ocular pathologies, including dry eye disease, persistent epithelial defects, and neurotrophic ulcers. Based on this knowledge, studies have been developed, and promising results regarding the use of insulin in corneal healing have been reported, providing a scientific foundation for the realization of this project. The objective of this study is to evaluate the effect of insulin eye drops at a concentration of 50 IU\u002Fml on epithelial healing in non-diabetic patients undergoing epithelial debridement for corneal crosslinking. To this end, a randomized, double-masked clinical trial will be conducted with two groups, one being the control group, in which researchers will compare the epithelial healing rate in mm²\u002Fh between the insulin group and the placebo group, as the primary outcome. Patients diagnosed with keratoconus and with an indication for the crosslinking procedure, will be invited to participate. As a result of the study, it is expected to assess and quantify the impact of topical insulin on epithelial defect closure in patients undergoing crosslinking, compared to placebo. Topical insulin may contribute to early epithelial defect closure, control of inflammation, and prevention of complications that could significantly impact visual quality.",[554,185,27,555],"Keratoconus","Wound Heal",[557,558],"Topical Insulin","Crosslinking","2025-01-10",{"date":561,"type":36},"2025-01-14",{"date":563,"type":36},"2024-08-01",{"date":458,"type":23},{"name":566,"class":142},"University of Campinas, Brazil",{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":575,"conditions":576,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":42},"100575690","precision-diagnosis-and-therapy-for-rare-diseases-by-interpreting-non-coding-genomes-100575690","NCT06775561","Precision Diagnosis and Therapy for Rare Diseases by Interpreting Non-coding Genomes","Precision Diagnosis and Therapy for Rare Diseases by Interpreting Non-coding Genomes (PARADIGM)","Inclusion Criteria:\n\n* patients\u002Frelatives of patients with clinical diagnosis of NMD\u002FED;\n* patients\u002Frelatives of patients with inconclusive ES and aCGH data (no pathogenic\u002Flikely pathogenic variant) or finding of only a single hit (a pathogenic or likely pathogenic variant) in an autosomal recessive gene by ES (or aCGH) or no pathogenic or likely pathogenic variant but detection of a large region of genomic homozygosity surrounding a candidate gene;\n* patients\u002Frelatives of patients with a finding of cryptic VUS (splicing\u002Fregulatory\u002Fnoncoding CNVs) in ED\u002FNMD genes or pathogenic cryptic variants in a selected number of representative cases.\n* Signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n\\- Trios or nuclear families where both unaffected parents do not consent to participate will be excluded (similarly, a minimum number of 3 affected family members will be needed in multigenerational pedigrees).",{"count":390,"type":23},"PARADIGM study, funded by the PNRR research grant, will focus on Eye Diseases (ED) and Neuro-Muscular Diseases (NMD) as groups of genetically heterogeneous diseases which are extensively studied by the Partners partecipating in the project; indeed ED and NMD are well clinically and molecularly characterized and approachable by drug-testing options already assessed and implemented by PARADIGM partners. ED and NMD represent good and compatible disease models as:\n\n* both are genetically heterogeneous disorders where missing heritability is likely to be hidden in non-coding variants;\n* many of the individual genes accountable for the ED and NMD cause autosomal recessive forms, increasing the chance of finding regulatory\u002Fsplicing variants",[577,27,578],"Neuromuscular Diseases","Genetic Disease","2025-01-09",{"date":581,"type":36},"2025-01-15",{"date":583,"type":36},"2023-05-20",{"date":585,"type":23},"2025-05-20",{"name":587,"class":142},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":592,"acronym":593,"eligibilityCriteria":594,"healthyVolunteers":17,"sex":18,"minAge":176,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":596,"conditions":597,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":42},"100565527","development-of-a-deep-learning-system-for-identification-of-neuro-ophthalmological-conditions-on-color-fundus-photographs-in-emergency-department-100565527","NCT06643338","Development of a Deep Learning System for Identification of Neuro-Ophthalmological Conditions on Color Fundus Photographs in Emergency Department","DEEP-VISION","Inclusion Criteria:\n\n* Patient aged 18 and over\n* Presenting to the emergency department of the Fondation Adolphe de Rothschild hospital\n* Express consent to participate in the study\n* Member or beneficiary of a social security scheme\n\nExclusion Criteria:\n\n* Patient under legal protection\n* Pregnant or breast-feeding women",{"count":97,"type":23},"In recent years, artificial intelligence (AI) has been widely integrated into the medical field, contributing in particular to improved patient diagnosis. The BONSAI study, Brain and Optic Nerve Study with AI, in which our team is participating, has successfully demonstrated the ability of AI to identify individual neuro-ophthalmological or neurological pathologies affecting the optic nerves and\u002For brain, from a simple fundus image.\n\nWhile this is a promising advance, it remains limited in current clinical practice. Our major challenge is to be able to identify a wider range of optic nerve and\u002For brain pathologies simultaneously in the same analysis, so as to improve patient management, especially for those referred to emergency departments. Indeed, in the absence of a precise diagnosis, complications can be irreversible and life-threatening.\n\nAmong the most alarming clinical signs in the emergency department is papilledema of stasis, which, accompanied by acute headaches, may indicate the presence of intracranial hypertension, inflammatory or ischemic pathology. The latter may be a manifestation of Horton's disease. Our team has developed an AI algorithm to diagnose retinal and optic nerve abnormalities based on retinophotographs taken under ideal conditions during scheduled consultations, and not on images of patients presenting to the emergency department. In hospitals without ophthalmology emergency departments, it is essential that emergency physicians (emergency physicians, general practitioners, neurologists) are able to assess the fundus in the absence of an ophthalmology specialist. This assessment, although part of the general examination, often presents challenges for non-ophthalmologists. The aim of our study is to improve the performance of our AI algorithm so that it can discriminate between different retinal and optic nerve pathologies in the emergency department. We therefore plan to build a database of fundus images by prospectively including patients presenting to the ophthalmology and neurology emergency departments of the Fondation Adolphe de Rothschild Hospital. The performance of the algorithm developed will be evaluated according to standard criteria of sensitivity, specificity, area under the curve (AUC) and accuracy.",[27],"2024-10-14",{"date":600,"type":36},"2024-10-16",{"date":602,"type":36},"2024-09-09",{"date":604,"type":23},"2027-10",{"name":606,"class":607},"Fondation Ophtalmologique Adolphe de Rothschild","NETWORK",{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":4,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":18,"minAge":151,"maxAge":20,"enrollmentInfo":615,"targetDuration":4,"studyType":54,"phases":617,"briefSummary":618,"conditions":619,"keywords":621,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":425},"100546384","phase-1-safety--efficacy-of-eyecyte-rpe-in-patients-with-geographic-atrophy-secondary-to-dry-age-related-macular-degeneration-100546384","NCT06394232","Safety & Efficacy of Eyecyte-RPE™ in Patients With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration.","A Phase 1\u002F2a Multi-Center, Dose-Escalation Study to Evaluate the Safety & Efficacy of Eyecyte-RPE™ When Administered as a Single-dose Subretinal Injection in Subjects With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration","Inclusion Criteria:\n\n1. Men and women ≥ 50 years of age at Screening.\n2. Diagnosis of Geographic Atrophy secondary to d-AMD\n3. Have Best Corrected Visual Acuity (BCVA) equal to or less than 20\u002F200 Snellen (ETDRS letter score ≤ 35) in the study eye at screening.\n\n   1. Phase 1 ≤ 20\u002F200 and\n   2. Phase 2a ≥ 20\u002F64 (ETDRS letter score 60) in the study eye at Screening.\n4. Vision in the unoperated eye must be better or equal to vision in the study eye.\n5. Willing, committed, and able to return for ALL clinic visits and complete all study related procedures.\n6. Be medically suitable to undergo anesthesia, vitrectomy and subretinal injection in the opinion of the Investigator.\n7. Be medically suitable for immunosuppression therapy in accordance with the requirements of this protocol in the opinion of the Investigator.\n8. Able to read (or if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) and understand, and willing to sign the informed consent form (ICF)\n9. Willing to provide signed Informed Consent prior to any procedures being performed at Visit 1, Screening.\n10. Negative for HIV, HbsAg, HCV, TB\n11. The GA lesion must meet the following criteria as determined by the central reading center's assessment of Fundus Autofluorescence (FAF) imaging at screening:\n\n    1. Total GA area must be ≥ 1.25 and ≤ 17.5 mm2 (0.5 and 7 disk areas \\[DA\\] respectively)\n    2. The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.\n    3. At least one of the lesions has to be sub-foveal.\n\nExclusion Criteria:\n\n1. Have evidence of neovascular AMD in either eye by clinical examination, fluorescein angiography or optical coherence tomography.\n2. Have GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like Chloroquine maculopathy in either eye.\n3. Have any evidence of active or inactive choroidal neovascularization (CNV) due to other causes such as ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, uveitis, punctate inner choroidopathy, or multifocal choroiditis in the study eye.\n4. Axial myopia greater than -6 diopters or axial length more than 26 mm.\n5. Have a decrease in BCVA in the study eye due to causes other than GA (e.g., pigment abnormalities, dense sub foveal hard exudates, previous vitreoretinal surgery, retinal dystrophies, non-retinal conditions, visually significant cataract, macular ischemia, etc.).\n6. Have the presence of retinal pigment epithelial tears or rips involving the macula in the study eye at screening.\n7. Have a history or evidence of vitreous hemorrhage in the study eye.\n8. Have a history or clinical evidence of severe diabetic retinopathy, diabetic macular edema, retinal vein occlusion or any other vascular disease affecting the retina in the study eye.\n9. Have had a prior pars plana vitrectomy in the study eye.\n10. Have a history of retinal detachment or treatment or surgery for retinal detachment in the study eye.\n11. Have history of a macular hole in the study eye.\n12. Have had any other ocular surgery (except cataract) within 2 months or Yttrium Aluminum Garnet (YAG) laser capsulotomy in the study eye in the past 4 weeks.\n13. Have had a prior trabeculectomy or other filtration surgery in the study eye.\n14. History of any form of glaucoma in the study eye.\n15. Patients with ocular pathology, particularly that of retina (other than AMD).\n16. Have active intraocular inflammation or a history or evidence of uveitis in either eye.\n17. Have active ocular or periocular infection in either eye, or a history of any ocular or periocular infection within the 2 weeks prior to Visit 1, Screening in either eye.\n18. Have a history of scleromalacia in either eye.\n19. Have had previous therapeutic radiation in the study eye.\n20. Have a history of corneal transplant or corneal dystrophy.\n21. Have any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.\n22. Have a history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.\n23. Have participated as a subject in any clinical study within 6 months prior to Day 0, Baseline.\n24. Have a known serious allergy to fluorescein sodium for injection in angiography, Povidone Iodine or any of the other medications required for anesthesia or the subretinal injection procedure.\n25. Be a female who is pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study at Screening and Baseline.\n26. Currently receiving aspirin, aspirin containing products and\u002For any other coagulation modifying drugs which cannot be discontinued 7 days prior to surgery.\n27. Have any systemic condition that would qualify the subject as being immunocompromised (e.g., severely uncontrolled diabetes, cancer).\n28. Patients with Optic Atrophy",{"count":616,"type":23},54,[471,237],"The goal of this clinical study is to evaluate the safety and efficacy of novel stem cell formulation in patients having Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (d-AMD).\n\nThe main questions it aims to answer are:\n\n* Safety and tolerability of the novel stem cell formulation\n* Potential efficacy of the novel stem cell formulation\n\nParticipants will receive a single subretinal injection in their study eye and followed up for safety.\n\nThis is an India only study and the product is developed indigenously.",[67,475,620,338,27],"Age-Related Macular Degeneration",[622,338,368,623,624,625],"Age Related Macular Degeneration","Subretinal injection","Stem cells","Retinal Pigment Epithelial Cells","2024-09-23",{"date":628,"type":36},"2024-09-24",{"date":630,"type":36},"2024-06-04",{"date":632,"type":23},"2030-12",{"name":634,"class":86},"Eyestem Research Pvt. Ltd.",{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":17,"sex":18,"minAge":642,"maxAge":4,"enrollmentInfo":643,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":645,"conditions":646,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":649,"lastUpdatePostDateStruct":650,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":655,"locationsCount":42},"100521505","holistic-mixed-approaches-to-capture-the-real-life-of-children-with-rare-eye-diseases-100521505","NCT06070467","Holistic Mixed Approaches to Capture the Real Life of Children With Rare Eye Diseases","SeeMyLife","Inclusion Criteria:\n\n* Children (age 8-12) and teenagers (age 13-18) with various levels of visual impairment defined according to World Health Organization (WHO) International Classification of Diseases (ICD) 10 - WHO ICD 10 \\[best-corrected visual acuity ≤ 0.3 decimal or ≤ 6\u002F18\\], and their parents\u002Fcaregivers.\n\nExclusion Criteria:\n\n* Children, teenagers, and caregivers:\n\n  1. who lack the ability to respond in a reliable way to the questions on how they feel about their visual impairment (patients with mild intellectual or cognitive deficiency may be able to reply accurately as opposed to cases with severe intellectual disability)\n  2. with functional or non-ophthalmic reasons of visual impairment\n  3. unable to provide consent\u002Fassent;\n  4. who do not speak\u002Fread the language","8 Years",{"count":644,"type":23},154,"Rare Eye Diseases (RED) are the leading cause of severe visual impairment\u002F blindness (SVI\u002FB) in children in Europe. This sensory disability with its accompanying psychological distress hugely impacts their lives and their families. Understanding this impact, at a patient centred level, is key in care, in shared decision making, in developing therapies, and in improving social integration and participation about the standard rules of the United Nations (UN) and the European Union (EU) (prevention, non-discrimination, equal opportunities, accessibility, etc.). However, current tools to evaluate vision related (VR) quality of life (QoL) VR-QoL disregard age and cultural differences. There is a lack knowledge on how the disease matters at child's level. Instruments capable of yielding high-quality data, psychometrically robust and comply with regulatory requirements remain to be developed.\n\nTo fill this gap, SeeMyLife will use multilevel concurrent mixed method research combining quantitative studies and qualitative studies. The quantitative approach is based on (i) cross culturally translated validated VR-QoL questionnaires for children and teenagers (Functional Vision Questionnaire for Children and Young People - FVQ-CYP and Vision-related Quality of Life Questionnaire for Children and Young People - VQoL-CYP) and (ii) on caregiver's questionnaires addressing participation and environment (Participation and Environment Measure - Children and Youth - PEM-CY). To fully capture the picture of the child\u002Fteenager personal life the investigators will reinforce their investigations by in depth qualitative socio-anthropologic study with semi directive field interviews and fieldwork (to observe closely the living conditions of the children) to address how their impairment affects their wellbeing, social integration, and how they feel about medical and social interventions. Data analysis will use an integrated mixed method strategy to validate the quantitative tools and deliver a holistic QoL transnational tool.\n\nThe SeeMyLife project will provide (i) robust patient self-reported tools that will be then used in care and research (especially with the rise in novel therapies) as a standard as well as (ii) highly awaited knowledge about the SVI\u002FB patient's position within his own life course, within his family and in relation to health and social care actors.",[27,647,60,648],"Severe Loss of Vision","Quality of Life","2024-08-27",{"date":651,"type":36},"2024-08-29",{"date":653,"type":36},"2024-07-17",{"date":247,"type":23},{"name":656,"class":142},"University Hospital, Strasbourg, France"]