[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531334":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":11,"responsibleParty":25,"collaborators":11,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":31,"acronym":11,"eligibilityCriteria":32,"healthyVolunteers":33,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":11,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":11,"overallStatus":46,"whyStopped":11,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":11},{"fullName":5,"class":6},"VIS, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Vision Improvement","EXPERIMENTAL",null,[13],"Procedure: Vision Improvement",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"PROCEDURE","Laser Vision Improvement for Patients with Age-Related Macular Degeneration",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Michael Berry, PhD","CONTACT","8318691384","mberry177@gmail.com",{"type":26,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100531334","vision-improvement-for-patients-with-age-related-macular-degeneration-100531334",false,"NCT06198452","Vision Improvement for Patients With Age-Related Macular Degeneration","Inclusion Criteria:\n\nSubjects who meet all of the following criteria are candidates for this study:\n\n1. Male or Female\n2. Any race\n3. Patient is at least 50 years old.\n4. Patient has diagnosed end stage dry or wet age-related macular degeneration in one or both eyes, as verified by a complete ocular examination.\n5. Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.\n6. Patient has manifest refraction, spherical equivalent (MRSE) between -1.50 D to 1.50 D in eye(s) to be treated.\n7. Patient has moderate to severe vision impairment due to age-related macular degeneration with best spectacle-corrected distance visual acuity (CDVA) of 20\u002F80 or worse (decimal less than or equal to 0.25; logMAR ≥ 0.60).in the better eye.\n8. Patient has CDVA of 20\u002F400 or better (decimal greater than or equal to 0.05; logMAR ≤ 1.30) in the worse eye.\n9. Patient is not a contact lens (CL) wearer.\n10. Patient is willing and able to comply with all examinations.\n11. Patient must be competent to sign an informed consent form before study entry.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria are to be excluded from this study:\n\n1. Corneal disease or corneal disorder in either eye.\n2. Pathological retinal morphology in either eye that completely affects the entire 10° (3 mm diameter) of the retina centered on the foveola.\n3. Gonzalez-Markowitz chart Potential Visual Acuity (PVA) in the eye to be treated that is not improved by at least four lines compared to CDVA;\n4. Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma;\n5. Previous corneal surgery in the eye to be treated; and\n6. Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or that may confound the outcome of the study.",true,"ALL","50 Years","100 Years",{"count":38,"type":39},200,"ESTIMATED","INTERVENTIONAL",[42],"NA","This study is being conducted to assess the safety and efficacy of the VIS, LLC (VIS) Opti-K Low Vision Aid Device and treatment to provide vision improvement to patients with age-related macular degeneration.",[45],"Macular Degeneration","NOT_YET_RECRUITING","2024-08-30",{"date":49,"type":50},"2024-09-05","ACTUAL",{"date":52,"type":39},"2025-01-01",{"date":54,"type":39},"2027-06-30",{"name":5,"class":6}]