What this study is
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.
What's being tested
- Ocufolin
Intervention · 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.
Study details
- Sponsor
- University of Miami
- Conditions
- Multiple Sclerosis · Dry Eye Syndromes · Diabetic Retinopathy · Presbyopia · Myopia · Dementia
- Enrolling
- 5,000 people
- Starts
- 2007-01-01
- Est. completion
- 2029-12-31
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 99 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Observational Phase 1 Group
- Self-reported normal healthy subjects;
- Clinical diagnosis of Alzheimer's Disease, mild cognitive impairment, multiple sclerosis, dry eye, myopia, diabetics and stroke;
- Who can keep the eye open for imaging.
- Is at least 18 years old and has full legal capacity to volunteer;
- Has read and signed the IRB Informed Consent Document;
- Is willing and able to follow participant instructions;
- Has clear corneas and crystalline lens;
- Initial visual acuities were 20/80 or better;
- MTHFR C677TT homozygous, or MTHFR C677T/A1298C compound heterozygous with mild to moderate micro-aneurismal vascular retinopathy disease;
- Hemoglobin A1c is 10 or less;
- Normotensive with or without medications;
- Without retinal capillary dropout or macular edema;
- Blood homocysteine > 9.
You can't join if
- Who can not read and sign the ICF;
- Who can not receiving ophthalmic imaging;
- Who cannot tolerate bright light during imaging.
- Has an active ocular disease;
- Has had surgery or an eye injury within 6 months.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBascom Palmer Eye Institute
Miami, Florida, United States
- Jianhua Wang, MD, PHD · Contact305-482-5010jwang3@med.miami.edu
- Jianhua Wang, MD, PhD · Principal investigator
Recruiting
Study team
Sponsor
University of Miami
Study ID 20070492
Principal investigator
Jianhua Wang, MD, PhD
Bascom Palmer Eye Institute, University of Miami, Miami, FL
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.