Using advanced eye imaging to assess conditions and effects of a medical food

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore the clinical applications of advanced ophthalmic imaging technologies, including optical coherence tomography and retinal function imaging, in both healthy individuals and those with various eye conditions. It consists of two phases: an observational phase that examines the eyes under different conditions, and an interventional phase that evaluates the effects of an over-the-counter medical food called Ocufolin over a six-month period. The study will help determine how these imaging techniques can be utilized in clinical settings to improve patient care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Bascom Palmer Eye Institute
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Jianhua Wang, MD, PhD — Bascom Palmer Eye Institute, University of Miami, Miami, FL
• Study coordinator: Jianhua Wang, MD, PhD
• Email: jwang3@med.miami.edu
• Phone: 3054825010

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.