RECRUITING Not applicable ClinicalTrials.gov

Clinical Applications of Advanced Ophthalmic Imaging

Sponsor: University of Miami • ClinicalTrials.gov ID: NCT03135327

Registry updated: 2026-09-16

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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. There 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.

Interventions

Ocufolin (Dietary supplement)
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.

Eligibility criteria

Observational Phase 1 Group Inclusion Criteria: 1. Self-reported normal healthy subjects; 2. Clinical diagnosis of Alzheimer's Disease, mild cognitive impairment, multiple sclerosis, dry eye, myopia, diabetics and stroke; 3. Who can keep the eye open for imaging. Exclusion Criteria: 1. who can not read and sign the ICF; 2. who can not receiving ophthalmic imaging; 3. who cannot tolerate bright light during imaging. Interventional Phase 2 Group: Inclusion criteria The participant will be eligible for entry in the study if s/he: 1. Is at least 18 years old and has full legal capacity to volunteer; 2. Has read and signed the IRB Informed Consent Document; 3. Is willing and able to follow participant instructions; 4. Has clear corneas and crystalline lens; 5. Initial visual acuities were 20/80 or better; 6. MTHFR C677TT homozygous, or MTHFR C677T/A1298C compound heterozygous with mild to moderate micro-aneurismal vascular retinopathy disease; 7. Hemoglobin A1c is 10 or less; 8. Normotensive with or without medications; 9. Without retinal capillary dropout or macular edema; 10. Blood homocysteine \> 9. Exclusion criteria The subjects will be ineligible for entry into the study if s/he: 1. Has an active ocular disease; 2. Has had surgery or an eye injury within 6 months.

Conditions

Multiple Sclerosis Dry Eye Syndromes Diabetic Retinopathy Presbyopia Myopia Dementia

Locations

Bascom Palmer Eye Institute — Miami, Florida, United States

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment