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Clinical Applications of Advanced Ophthalmic Imaging

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how advanced eye imaging tools can be used in people with healthy eyes or certain health conditions. The first phase observes the eyes without treatment. The second phase studies eye changes after taking Ocufolin, an over-the-counter medical food, for 6 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Phase 1: People who report being healthy, or who have Alzheimer's disease, mild memory or thinking problems, multiple sclerosis, dry eye, nearsightedness, diabetes, or stroke.
  • Phase 1: Must be able to keep the eye open for imaging.
  • Phase 2: Must be at least 18, legally able to volunteer, have read and signed the consent form, and be willing and able to follow study instructions.
  • Phase 2: Must have clear corneas and lenses (parts of the eye that let light in), and starting vision of 20/80 or better.
  • Phase 2: Must have specific MTHFR gene changes—C677TT in both copies, or C677T/A1298C—and mild to moderate disease with tiny bulges in blood vessels in the retina, the light-sensing layer at the back of the eye.
  • Phase 2: Must have an A1c level (a blood sugar measure) of 10 or less and normal blood pressure, with or without medicine.
  • Phase 2: Must have no loss of tiny working blood vessels in the retina and no swelling in its central area.
  • Phase 2: Must have a blood homocysteine level above 9. Homocysteine is a substance measured in the blood.

Who can't join

  • Phase 1: Cannot read and sign the study consent form.
  • Phase 1: Cannot have eye imaging.
  • Phase 1: Cannot handle bright light during imaging.
  • Phase 2: Have an active eye disease.
  • Phase 2: Have had surgery or an eye injury within the past 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

FL