[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03135327":3,"trial-entities:NCT03135327":100,"trial-summary:NCT03135327":110},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":24,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":55,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":70,"locations":73,"central_contacts":92,"overall_officials":95,"references":98,"see_also_links":99},"NCT03135327","20070492","Clinical Applications of Advanced Ophthalmic Imaging","RECRUITING","2029-12-31","2025-08","2025-08-12","2007-01-01","University of Miami","OTHER",false,"The purpose of this study is to determine the clinical application of advanced ophthalmic imaging devices such as optical coherence tomography (OCT), retinal function imager (RFI), slit-lamp biomicroscopy (SLB), PERG in diseased eyes and normal controls.\n\nThere are two phases in this study. The first phase is an observational phase which studies the eye in various conditions. The second phase is an interventional phase which studies the changes in the eyes after taking an over-the-counter medical food (Ocufolin) for 6 months.",null,[18,19,20,21,22,23],"Multiple Sclerosis","Dry Eye Syndromes","Diabetic Retinopathy","Presbyopia","Myopia","Dementia",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[28],"NA",{"count":30,"type":31},5000,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DIETARY_SUPPLEMENT","Ocufolin","Ocufolin medical food capsules will be taken once a day by mouth each morning with a meal for the first week, two capsules orally each morning with a meal for the second week and three capsules orally each morning with a meal for the rest of the 6 months study duration.",[38],"Interventional Phase - Ocufolin Group",[40,44,47,50,53],{"measure":41,"description":42,"timeFrame":43},"Retinal microstructure using OCT.","Optical coherence tomography is used to measure the thickness of intraretinal layers. The measurement is in micrometer.","up to 2 years",{"measure":45,"description":46,"timeFrame":43},"Retinal vasculature by optical coherence tomography angiography (OCTA)","Retinal vascular network density in percentage.",{"measure":48,"description":49,"timeFrame":43},"Conjunctival vasculature by functional slit-lamp (FSLB)","Conjunctival vascular network density in percentage.",{"measure":51,"description":52,"timeFrame":43},"Corneal epithelial thickness","Measured in micrometers using ultra high resolution OCT",{"measure":54,"description":52,"timeFrame":43},"Tear film thickness",[56,59],{"measure":57,"description":58,"timeFrame":43},"Retinal blood flow velocity by retinal function imager (RFI)","Retinal blood flow velocity in mm\u002Fs",{"measure":60,"description":61,"timeFrame":43},"Conjunctival blood flow velocity by functional slit-lamp (FSLB)","Conjunctival blood flow velocity in mm\u002Fs","ALL","18 Years","99 Years",true,{"inclusion":67,"exclusion":68,"raw_text":69},[],[],"Observational Phase 1 Group\n\nInclusion Criteria:\n\n1. Self-reported normal healthy subjects;\n2. Clinical diagnosis of Alzheimer's Disease, mild cognitive impairment, multiple sclerosis, dry eye, myopia, diabetics and stroke;\n3. Who can keep the eye open for imaging.\n\nExclusion Criteria:\n\n1. who can not read and sign the ICF;\n2. who can not receiving ophthalmic imaging;\n3. who cannot tolerate bright light during imaging.\n\nInterventional Phase 2 Group:\n\nInclusion criteria\n\nThe participant will be eligible for entry in the study if s\u002Fhe:\n\n1. Is at least 18 years old and has full legal capacity to volunteer;\n2. Has read and signed the IRB Informed Consent Document;\n3. Is willing and able to follow participant instructions;\n4. Has clear corneas and crystalline lens;\n5. Initial visual acuities were 20\u002F80 or better;\n6. MTHFR C677TT homozygous, or MTHFR C677T\u002FA1298C compound heterozygous with mild to moderate micro-aneurismal vascular retinopathy disease;\n7. Hemoglobin A1c is 10 or less;\n8. Normotensive with or without medications;\n9. Without retinal capillary dropout or macular edema;\n10. Blood homocysteine \\> 9.\n\nExclusion criteria\n\nThe subjects will be ineligible for entry into the study if s\u002Fhe:\n\n1. Has an active ocular disease;\n2. Has had surgery or an eye injury within 6 months.",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":75,"status":7,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":89},"Bascom Palmer Eye Institute","Miami","Florida","33136","United States",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Jianhua Wang, MD, PHD","CONTACT","305-482-5010","jwang3@med.miami.edu",{"name":87,"role":88},"Jianhua Wang, MD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":90,"lon":91},25.77427,-80.19366,[93],{"name":87,"role":83,"phone":94,"email":85},"3054825010",[96],{"name":87,"affiliation":97,"role":88},"Bascom Palmer Eye Institute, University of Miami, Miami, FL",[],[],{"nct_id":4,"conditions":101,"biomarkers":106},[102,20,103,104,18,22,21,105],"Alzheimer's Disease","Dry Eye Syndrome","Mild cognitive disorder","Stroke",[107,108,109],"Hemoglobin A, Glycosylated","Homocysteine","MTHFR Gene",{"nct_id":4,"found":65,"summary":111,"prompt_version":121},{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This study has two phases: an observational phase and an interventional phase. It plans to enroll up to 5000 participants.","completed","Advanced Ophthalmic Imaging and Ocufolin Study","This study is looking at how advanced eye imaging tools, like optical coherence tomography (OCT), can be used to understand different eye conditions. It has two parts. The first part observes eyes in people with conditions like multiple sclerosis, dry eye, or myopia, as well as healthy individuals. The second part will study how eyes change after taking a dietary supplement called Ocufolin for six months. Researchers will measure changes in your retina (the light-sensitive tissue at the back of your eye) and blood vessels in your eye for up to two years. This study is open to adults aged 18 to 99 with various eye conditions or healthy vision. The current status of the study is unclear.","Your retinal microstructure and vasculature will be measured for up to two years.",118,"If you participate in the interventional phase, you would take Ocufolin capsules by mouth once a day for the first week, then two capsules daily for the second week, and three capsules daily for the remaining six months. You would also undergo eye imaging tests.","Not stated in the trial record.",[35],"v2"]