No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 99
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
5,000 (estimated)
Sponsor
University of Miami · Other
Who this trial is looking for
This trial is looking for individuals with eye conditions such as diabetic retinopathy or multiple sclerosis to test advanced eye imaging and the effects of an over-the-counter medical food called Ocufolin over 6 months. Participants will undergo eye imaging and follow instructions related to the study.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I have clear corneas and crystalline lens
My initial vision is 20/80 or better
I have mild to moderate micro-aneurismal vascular retinopathy
My hemoglobin A1c is 10 or less
I have been diagnosed with an eye condition
I can follow participant instructions
You may not be able to join if
I have an active ocular disease
I have had surgery or an eye injury within the last 6 months
I cannot read and sign the consent form
I cannot tolerate bright light during imaging
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 a…
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.
Trial Locations
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Status
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 n…
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.
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