[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466567":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":69,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":10,"eligibilityCriteria":81,"healthyVolunteers":78,"sex":82,"minAge":83,"maxAge":10,"enrollmentInfo":84,"targetDuration":10,"studyType":87,"phases":10,"briefSummary":88,"conditions":89,"keywords":10,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Food and Drug Administration (FDA)","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Outer retinal disease",null,"Subjects with outer retinal disease affecting the photoreceptor-retinal pigment epithelium complex will be classified by clinical exam by an experienced retina specialist. Outer retinal disease subjects will undergo adaptive optics (AO) imaging of several macular locations.",[13],"Device: Adaptive optics imaging",{"label":15,"type":10,"description":16,"interventionNames":17},"Healthy control","Age-matched healthy control subjects will undergo the same AO imaging procedures as subjects with outer retinal diseases.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","Adaptive optics imaging","Adaptive optics scanning laser ophthalmoscopy (AOSLO) and adaptive optics - optical coherence tomography (AO-OCT) retinal imaging",[15,9],[25],{"name":26,"affiliation":5,"role":27},"Daniel X Hammer, Ph.D.","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":10,"email":32},"CONTACT","301-796-9320","daniel.hammer@fda.hhs.gov",{"name":34,"role":30,"phone":35,"phoneExt":10,"email":36},"Zhuolin Liu, Ph.D.","301-796-7914","zhuolin.liu@fda.hhs.gov",[38,57],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"NIH Clinical Center","RECRUITING","Bethesda","Maryland","20810","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-77.10026,38.98067,{"lat":50,"lon":49},[53],{"name":54,"role":30,"phone":55,"phoneExt":10,"email":56},"Catherine Cukras, M.D., Ph.D.","301-435-5061","cukrasc@nei.nih.gov",{"facility":58,"status":40,"city":59,"state":42,"zip":60,"country":44,"countryCode":45,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Food and Drug Administration","Silver Spring","20993",{"type":47,"coordinates":62},[63,64],-77.02609,38.99067,{"lat":64,"lon":63},[67,68],{"name":26,"role":30,"phone":31,"phoneExt":10,"email":32},{"name":34,"role":30,"phone":35,"phoneExt":10,"email":36},{"type":27,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Daniel X. Hammer","Deputy Director, Division of Biomedical Physics",[73],{"name":74,"class":75},"National Eye Institute (NEI)","NIH","100466567","adaptive-optics-imaging-of-outer-retinal-diseases-100466567",false,"NCT05355415","Adaptive Optics Imaging of Outer Retinal Diseases","Inclusion Criteria:\n\n1. Are 21 years of age or older,\n2. Have the ability to cooperate with instructions during adaptive optics imaging (similar to instructions given during a clinical eye exam),\n3. Have the ability to understand and sign an informed consent. (Non-English speaking participants will not be enrolled into the study), and\n4. Have been diagnosed with outer retinal disease or condition (Cohort 2).\n\nExclusion Criteria:\n\n1. Have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity),\n2. Have visual correction outside of the range +4 diopters (D) to -8 D,\n3. Have a history of adverse reaction to mydriatic drops,\n4. Have a predisposition to (i.e., narrow iridocorneal angle) or any history of acute angle closure glaucoma (AACG), or\n5. Are working under the direct supervision of Drs. Hammer, Cukras and Liu, or any of the NIH\u002FNEI AIs.","ALL","21 Years",{"count":85,"type":86},100,"ESTIMATED","OBSERVATIONAL","The objective of the study is to collect adaptive optics (AO) retinal images from human subjects with outer retinal diseases (diseases of the outer retina including photoreceptor, retinal pigment epithelium (RPE), basement membrane or choroidal pathologies) to develop new diagnostic methods, biomarkers, and clinical endpoints.",[90,91,92,93,94,95,96,97,98,99],"Retinal Degeneration","Age-Related Macular Degeneration","Retinitis Pigmentosa","Hydroxychloroquine Retinopathy","Usher Syndromes","Late-Onset Retinal Degeneration","Cone Dystrophy","Cone Rod Dystrophy","Rod Cone Dystrophy","Rod Dystrophy","2026-05-06",{"date":102,"type":103},"2026-05-08","ACTUAL",{"date":105,"type":103},"2021-08-27",{"date":107,"type":86},"2028-09-30",{"name":5,"class":6},2]