NCT03135327Recruiting
Clinical Applications of Advanced Ophthalmic Imaging
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 5000 (estimated)
- First submitted
- 24 Apr 2017
- Start date
- 1 Jan 2007
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- University of Miami
- Diseases
- Multiple sclerosis, Diabetic eye disease
- NCT number
- NCT03135327
What you commit to
- Study type: Interventional
- Planned participants: 5000
- From 1 Jan 2007 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- who can not receiving ophthalmic imaging;
- Has had surgery or an eye injury within 6 months.
Other illness
- Has an active ocular disease;
Other
- who can not read and sign the ICF;
- who cannot tolerate bright light during imaging.
- Interventional Phase 2 Group:
- The subjects will be ineligible for entry into the study if s/he:
Who the study is looking for
- 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.
- The participant will be eligible for entry in the study if s/he:
- 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.
Criteria the registry did not label
- Observational Phase 1 Group
Age in the registry: 18 years to 99 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bascom Palmer Eye Institute Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.