[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Carl Zeiss Meditec AG\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":135},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,67,89,111],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100600017","extended-depth-of-focus-edf-intraocular-lens-iol-versus-monofocal-intracoular-lens-iol-100600017",false,"NCT07092020","Extended Depth of Focus (EDF) Intraocular Lens (IOL) Versus Monofocal Intracoular Lens (IOL)","A Prospective, Randomized, Controlled, Observer-masked, Multi-center Clinical Trial to Demonstrate the Safety and Effectiveness of the Extended Depth of Focus AT LARA 829MP Posterior Chamber Intraocular Lens for Correction of Aphakia","Inclusion Criteria:\n\n1. Patients of any gender, aged 18 years or older\n2. Patient with clinically significant bilateral age-related cataracts planned for phacoemulsification cataract extraction and eligible for implantation of a posterior chamber intraocular lens as determined by investigator's medical judgement\n3. Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D)\n4. Calculated lens power within the available range\n5. Clear intraocular media other than cataract\n6. Patient is willing and capable of providing informed consent\n7. Patient is willing and capable of complying with visits and procedures as defined by this protocol\n\nExclusion Criteria:\n\n1. Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)\n2. Endothelial cell count of less than 2000\u002Fmm2\n3. Acute, chronic, or uncontrolled systemic disease that could increase the operative risk or confound the outcome including but not limited to poorly controlled diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc.\n4. Ocular condition that may predispose patient to future complications, per investigator's medical judgement, including but not limited to severe dry eye, anterior segment pathology, uncontrolled glaucoma, that would result in a visual acuity of 0.2 logMAR or worse during the study\n5. Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity or oedema as per Investigator's medical judgement; conditions including but not limited to kerato-uveitis, keratopathy, keratectasia\n6. Previous intraocular or corneal\u002Frefractive surgery that might confound the outcome of the investigation or increase the risk to the patient (including corneal transplants, removal of pterygium, and LASIK, LASEK, PRK, RK limbal relaxing incision etc.)\n7. Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)\n8. Patients with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders, optic nerve atrophy etc.) or any other pathologies of the eye that are predicted to result in a visual acuity of 0.2 logMAR or worse during the study\n9. Current systemic or ocular pharmacotherapy that effects patients' vision with significant ocular side effects or any medications that could confound the outcome or increase subject risk\n10. Clinically significant gonioscopic abnormalities\n11. Amblyopia, strabismus, single eye status\n12. Rubella, congenital, traumatic or complicated cataracts\n13. History of or current anterior or posterior segment inflammation, including but not limited to iritis or uveitis\n14. Microphthalmos or macrophthalmos\n15. Pupil abnormalities (e.g. aniridia, abnormal shaped pupils, nonreactive pupils)\n16. Pseudoexfoliation\n17. Keratoconus or irregular astigmatism\n18. Inability to measure keratometry or biometry (including but not limited to cataract density, etc.)\n19. Pathologic miosis\n20. Pregnant, plan to become pregnant, lactating during the course of the investigation, or another condition with associated fluctuation of hormones that could lead to refractive changes\n21. Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial\n22. Patients whose freedom is impaired by administrative or legal order\n23. Concurrent participation in another clinical investigation in the last 30 days.","ALL","18 Years",{"count":19,"type":20},220,"ESTIMATED","INTERVENTIONAL",[23],"NA","Extended depth of focus (EDF) intraocular lens (IOL) versus Monofocal intraocular lens (IOL)",[26],"Cataract Senile",[28,29],"IOL","Cataract","RECRUITING","2026-03-11",{"date":33,"type":34},"2026-03-12","ACTUAL",{"date":36,"type":34},"2025-10-01",{"date":38,"type":20},"2027-10",{"name":40,"class":41},"Carl Zeiss Meditec AG","INDUSTRY",14,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100629178","phase-4-toric-performance-and-constant-evaluation-100629178","NCT07471295","Toric Performance And Constant Evaluation","Prospective Assessment of Constant Optimization and Visual Outcomes Following Monofocal Toric IOL Implantation","PACE","Inclusion Criteria:\n\n* Aged 18 years or older;\n* Patients willing, able, and with sufficient cognitive awareness to comply with examination procedures and schedule for follow-up visits;\n* Patients with clinically significant age-related cataract (cataract grades of 1, 2, 3 on the LOCSIII scale, but otherwise healthy, requiring surgical treatment, and scheduled for unilateral or bilateral phacoemulsification or Femtosecond-Laser-Assisted cataract surgery;\n* Patients with existing regular corneal astigmatism of minimum 0.75 D in at least the first eye to be operated.\n* Signed informed consent form;\n* Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment;\n* Calculated IOL power within the range of the investigational IOL; SE +18.0 D to +28.0 D (0.5 D Steps), and between a Cylinder range of +1.0 D to +2.5 D (0.5 D Steps);\n* Dilated pupil size large enough to visualize TIOL axis markings postoperatively; at least 5.5mm;\n* Clear intraocular media other than cataract.\n\nExclusion Criteria:\n\n* Previous intraocular or corneal surgery in either eye that might confound the outcome of the study or increase the risk to the subject;\n* Keratometric astigmatism (assessed by IOL Master) of minimum 0.75 D in the first eye\n* Traumatic cataract;\n* Pregnancy or lactation;\n* Concurrent participation in another drug or device investigation within the last 30 days;\n* Irregular astigmatism;\n* Instability of keratometry or biometry measurements;\n* Subjects wearing contact lenses as standard vision aid;\n* Abnormal pupil;\n* Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.);\n* History of concurrent intraocular inflammation;\n* Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or clinically significant corneal membrane dystrophies);\n* History of any clinically significant retinal or ocular pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus, epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or limit final postoperative visual prognosis;\n* Pseudoexfoliation syndrome (according to investigator judgement);\n* Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment;\n* All kind of infections (acute ocular disease, external \u002F internal infection, systemic infection);\n* Monophthalmic patient;\n* Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus, Parkinson disease\n* Patient expected to require retinal laser treatment before the end of the last follow-up examination;\n* Patient expected to require refractive laser treatment \u002F refractive laser touch-up before the end of the last follow-up examination;\n* Patients who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than Nd:YAG capsulotomy)\n* In case of both eyes included in this trial: Patients who need to undergo surgery on both eyes on the same day",{"count":52,"type":20},130,[54],"PHASE4","The main purpose of this investigation is to support safety and performance assessment of the investigational device with a focus on optimizing the IOL constants based on refractive outcomes.",[29],"NOT_YET_RECRUITING","2026-03-10",{"date":60,"type":34},"2026-03-13",{"date":62,"type":20},"2026-05-01",{"date":64,"type":20},"2028-02-28",{"name":40,"class":41},6,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100599442","evaluation-of-cataract-surgery-outcomes-in-patients-with-prior-laser-vision-correction-implanted-with-the-ct-lucia-lens-100599442","NCT07084545","Evaluation of Cataract Surgery Outcomes in Patients With Prior Laser Vision Correction Implanted With the CT LUCIA Lens","EPIC: Evaluation of the Postoperative Cataract Surgery Outcomes in Patients With Prior Corneal Laser Vision Correction Implanted With the CT LUCIA Intraocular Lens Protocol GPAS-SAS-023-4","Inclusion Criteria:\n\n1. Be at least 18 years of age or older.\n2. Previous cornea LVC surgery performed at least 1 year before the implantation of the CT LUCIA 621P IOL, such as Laser-Assisted Intrastromal Keratomileusis (LASIK), Laser-Assisted Subepithelial Keratectomy (LASEK), Photorefractive Keratectomy (PRK) or Small Incision Lenticule Extraction (SMILE) for mild to moderate myopia, with or without astigmatism (up to, but not including, -6.0 D sphere in any meridian for myopic ablations.\n3. Presenting for planned bilateral cataract extraction with in-the-bag posterior chamber IOL implantation, via phacoemulsification with or without femtosecond laser assisted cataract surgery (FLACS). Astigmatism management techniques, such as Astigmatic Keratotomy (AK), may be utilized during cataract surgery to target a predicted postoperative cylinder less than 0.75 D.\n4. Clear intraocular media other than cataract (i.e., no hyphema, vitreous hemorrhage).\n5. No visual acuity limiting corneal or retinal pathologies.\n6. Able to and having provided written informed consent and a signed Health Insurance Portability and Accountability Act (HIPAA) form.\n7. Availability, willingness, ability, and sufficient cognitive awareness to comply with study examination procedures and the schedule for study visits and evaluations.\n\nExclusion Criteria:\n\n1. Implantation of an IOL other than the CT LUCIA 621P in one or both eyes.\n2. Eyes with preoperative anterior corneal astigmatism of ΔTK ≥1.00 D as measured by the IOLMaster 700 or with greater than 0.75 D predicted post-operative astigmatism at the spectacle plane.\n3. Visual field loss which has an impact on visual acuity.\n4. Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that would confound visual acuity measurement.\n5. Subjects with surgical complications in whom a CT LUCIA 621P IOL cannot be implanted in either eye.\n6. Eyes with irregular corneal astigmatism, epithelial basement membrane dystrophy, chronic dry eye requiring continual treatment, underwent more than one LVC procedure in one or both eyes, or complications from the previous LVC which required additional surgical intervention.\n7. Subjects with planned ocular surgery during the study (except Nd:YAG capsulotomy is permitted).\n8. History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the opinion of the investigator, confound results.\n9. Current diagnosis of macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, or other chronic ocular conditions that would confound the study results.\n10. A current diagnosis of moderate or severe glaucoma.\n11. Patients with strabismus, forme fruste keratoconus, keratoconus or other corneal pathologies that would confound visual acuity measurement.\n12. Previous radial keratotomy (RK).\n13. Previous corneal keratoplasty (e.g., corneal transplant, Descemet's stripping automated endothelial keratoplasty (DSAEK), lamellar keratoplasty).\n14. Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy).\n15. Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate under mesopic\u002Fscotopic conditions).\n16. Capsular or zonular abnormalities or other conditions that may affect the postoperative centration or tilt of the lens (e.g., pseudoexfoliation syndrome).\n17. Usage of contact lenses during study participation.\n18. Concurrent participation in another device investigation.",{"count":75,"type":20},30,"OBSERVATIONAL","This is a prospective, Phase IV, post-approval observational study evaluating postoperative outcomes in patients with a history of myopic corneal laser vision correction (LVC) undergoing bilateral cataract surgery with implantation of the CT LUCIA 621P intraocular lens (IOL). Up to 30 subjects (60 eyes) will be enrolled across up to three U.S. investigational sites. The study will assess visual and refractive outcomes, including biometry, manifest refraction, and patient-reported visual function over a 3-month follow-up period.",[79],"Postoperative Visual Outcomes Following Cataract Surgery in Patients With Prior Myopic Corneal Laser Vision Correction","2025-07-22",{"date":82,"type":34},"2025-07-24",{"date":84,"type":20},"2025-07",{"date":86,"type":20},"2026-09",{"name":40,"class":41},2,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100589928","evaluation-of-refractive-outcomes-in-patients-undergoing-presbyond-using-the-mel90-excimer-laser-100589928","NCT06960785","Evaluation of Refractive Outcomes in Patients Undergoing PRESBYOND Using the MEL90 Excimer Laser","Inclusion Criteria:\n\n1. Subjects between 45 and 65 years old\n2. Scheduled to undergo bilateral LASIK treatment with PRESBYOND\n3. Preoperative corrected distance visual acuity of 20\u002F20 Snellen or better in each eye\n4. Normal corneal topography in each eye\n5. Discontinue use of contact lenses at least 1 month for hard contacts and 1 week for soft lenses prior to the preoperative examination\n6. Residual stromal thickness ≥250 microns in each eye\n7. Availability, willingness, to comply with examination follow up visits\n8. Signed informed consent and data protection documents\n9. Patients successfully passed the tolerance test\n\nExclusion Criteria:\n\n1. Mixed astigmatism in any eye\n2. Irregular corneal astigmatism in any eye\n3. Clinically significant ocular surface disease in any eye\n4. History of ocular surgery, ocular pathology, or other significant ocular findings that, in the Investigator's opinion, may increase the patient's risk for corneal refractive surgery or affect potential visual outcomes in each eye\n5. Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc,) in each eye\n6. Amblyopia, strabismus, nystagmus, forme fruste keratoconus in any eye\n7. Clinically significant pupil abnormalities in any eye\n8. Use of systemic or ocular medications that may affect visual outcomes\n9. Systemic pathology that may affect the results of the study\n10. Pregnancy or being treated for conditions associated with hormonal fluctuation\n11. Participation in another clinical trial in the last 30 days","45 Years","65 Years",{"count":98,"type":20},75,"The goal of this clinical trial is to collect information on vision outcomes in people aged 45 to 65 who have difficulty seeing clearly at near distances due to aging (a condition called presbyopia). All participants will receive the same treatment: laser eye surgery with the PRESBYOND method using the MEL 90 excimer laser.\n\nThe main questions this study aims to answer are:\n\n* How well do patients see at distance, intermediate, and near after treatment?\n* How satisfied are patients with their vision after surgery?\n\nParticipants will:\n\n* Attend seven visits over six months (before surgery and after surgery at 1 day, 1 week, 1 month, 3 months, and 6 months)\n* Undergo laser eye surgery with PRESBYOND\n* Complete vision tests and questionnaires about their experience\n\nThere is no comparison group in this study.",[101],"Presbyopia","2025-04-29",{"date":104,"type":34},"2025-05-07",{"date":106,"type":20},"2025-05",{"date":108,"type":20},"2026-02",{"name":40,"class":41},3,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":16,"minAge":120,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100549049","phase-4-evaluation-of-a-monofocal-intraocular-lens-100549049","NCT06428955","Evaluation of a Monofocal Intraocular Lens","Prospective Multicenter Evaluation of the Visual Performance of a Non-constant Aberration Correcting Aspheric Monofocal Intraocular Lens (Precise Study)","PRECISE","Inclusion Criteria:\n\n1. Be at least 50 years of age or older, male or female, of any race or ethnicity.\n2. Presenting for uncomplicated bilateral cataract surgery for age-related cataract.\n3. Planned bilateral cataract extraction with posterior chamber IOL implantation, via phacoemulsification with or without femtosecond laser assisted cataract surgery (FLACS).\n4. Bilateral implantation of a CT LUCIA 621P IOL with a dioptric power between +10.00 D and +30.00 D and a target postoperative refraction of emmetropia (0.00 ±0.50 D).\n5. Clear intraocular media other than cataract (i.e. no hyphema, vitreous hemorrhage)\n6. No visual acuity limiting pathologies other than cataract. Best corrected postoperative visual acuity potential of 20\u002F25 or better in both eyes as estimated by potential acuity meter or surgeon estimation.\n7. Provide written informed consent and a signed HIPPA form.\n8. Availability, willingness, ability, and sufficient cognitive awareness to comply with study examination procedures and the schedule for study visits and evaluations.\n\nExclusion Criteria:\n\n1. Corneal Astigmatism of \\>1.0 D.\n2. Planned monocular cataract extraction.\n3. Visual field loss which has an impact on visual acuity.\n4. Subjects with intraoperative surgical complications in whom a CT LUCIA 621P IOL cannot be implanted.\n5. History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the surgeon's opinion, confound results (e.g., corneal pathology, keratoconus, strabismus, uncontrolled glaucoma)\n6. History of Glaucoma, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc.\n7. Previous intraocular or corneal surgery, including all forms of refractive surgery that might confound the outcome of the investigation or increase the risk to the subject\n8. Previous anterior or posterior chamber surgery other than peripheral retinal barrier laser, SLT\u002FALT (e.g., vitrectomy, laser iridotomy)\n9. Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic\u002Fscotopic conditions).\n10. Capsular or zonular abnormalities or other conditions that increase the risk of zonular rupture during cataract extraction procedure and\u002For may affect the postoperative centration or tilt of the lens\n11. Use of a systemic or ocular medication that might affect vision and confound the outcome or increase the risk to the subject in the opinion of the investigator such as tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome)\n12. Cycloplegic pupil diameter \\\u003C6.0 mm or the presence of ocular implants that limit pupil diameter (malyugin rings; iris prosthesis).\n13. Usage of contact lenses during study participation\n14. Pregnant, lactating during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes\n15. Presence or history or any other condition or finding that, in the investigator's opinion, makes the subject unsuitable as a candidate for study participation, may increase the operative risk or may confound the outcome of the study.",true,"50 Years",{"count":122,"type":20},44,[54],"The aim of this study is to investigate the 3-month visual performance of the CT LUCIA 621P IOL, a hydrophobic aspheric monofocal IOL with a non-constant aspheric optic profile in adult patients 50 years of age or older who are undergoing cataract surgery.",[29],"2024-06-19",{"date":128,"type":34},"2024-06-24",{"date":130,"type":34},"2024-06-06",{"date":132,"type":20},"2024-12",{"name":40,"class":41},4,""]