Recruiting

Ophthalmic Imaging

Sponsor:

University of Miami

Code:

NCT03135327

Conditions

Multiple Sclerosis

Dry Eye Syndromes

Diabetic Retinopathy

Presbyopia

Myopia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Ocufolin

Study Details

Brief summary:

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.

Conditions

Multiple Sclerosis

Dry Eye Syndromes

Diabetic Retinopathy

Presbyopia

Myopia

Study ID

NCT03135327

Start date

Jan 1, 2007

Status verified date

Aug, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

5000 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Interventional Phase - Ocufolin Group

Participants in this group will receive the Ocufolin medical food for 6 months.

no intervention: Observational Phase Group

Participants in this group will be studied and followed up for 1-2 years.

Interventions

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.

Primary outcome measure

  • Retinal microstructure using OCT. [ Time Frame: up to 2 years ]
  • Retinal vasculature by optical coherence tomography angiography (OCTA) [ Time Frame: up to 2 years ]
  • Conjunctival vasculature by functional slit-lamp (FSLB) [ Time Frame: up to 2 years ]
  • Corneal epithelial thickness [ Time Frame: up to 2 years ]
  • Tear film thickness [ Time Frame: up to 2 years ]

Central Contacts and Locations

Central contacts

Jianhua Wang, MD, PhD

3054825010jwang3@med.miami.edu

Locations

Bascom Palmer Eye Institute

Recruiting

Miami, Florida, United States, 33136

Contacts

Principal Investigator:

Jianhua Wang, MD, PhD

More Information

Sponsor

University of Miami

Last update posted

Aug 12, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2025-08-12.