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

Clinical Applications of Advanced Ophthalmic Imaging

This study is testing how advanced eye imaging can help us understand eye conditions and see if a special medical food called Ocufolin can improve eye health over six months for both healthy people and those with eye issues.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 5000 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: University of Miami (other)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT03135327 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals with conditions such as multiple sclerosis, dry eye syndromes, diabetic retinopathy, presbyopia, myopia, or healthy individuals willing to participate.

Not a fit: Patients who cannot tolerate bright light during imaging or those with severe visual impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding and management of eye diseases, potentially leading to better treatment options for patients.

How similar studies have performed: Other studies utilizing advanced imaging techniques have shown promise in improving diagnosis and treatment of eye conditions, suggesting a potential for success in this approach.

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.

Where this trial is running

Miami, Florida

• 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

Conditions: Multiple Sclerosis, Dry Eye Syndromes, Diabetic Retinopathy, Presbyopia, Myopia, Dementia