Actively Recruiting
Clinical Applications of Advanced Ophthalmic Imaging Using OCT, RFI, SLB, and Ocufolin Medical Food
Led by University of Miami · Updated on 2025-08-12
5000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical use of advanced eye imaging tools such as optical coherence tomography OCT, retinal function imager RFI, slit-lamp biomicroscopy SLB, and pattern electroretinogram PERG in both diseased eyes and healthy controls. The study includes people with various eye-related conditions including multiple sclerosis, dry eye syndromes, diabetic retinopathy, presbyopia, myopia, and dementia. The study aims to better understand eye conditions through detailed imaging and functional assessments. The study has two phases. The first phase is observational, where participants undergo imaging and eye examinations without treatment. The second phase is interventional, where participants take an over-the-counter medical food called Ocufolin daily for six months with a gradually increasing dose. Participants in the interventional phase take one capsule each morning for one week, two capsules each morning for the second week, and three capsules each morning for the remaining four and a half months. Participants will be followed and assessed for up to two years. Eye structure and function will be measured using OCT, optical coherence tomography angiography OCTA, functional slit-lamp biomicroscopy FSLB, and retinal function imager RFI. Measurements include retinal microstructure, retinal and conjunctival blood flow, corneal thickness, and tear film thickness. The study includes regular imaging and visual acuity testing, with the goal of understanding changes in eye health and vascular function over time.
CONDITIONS
Brief Title
Clinical Applications of Advanced Ophthalmic Imaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 99 years
- Self-reported normal healthy subjects or clinical diagnosis of Alzheimer's disease, mild cognitive impairment, multiple sclerosis, dry eye, myopia, diabetes, or stroke
- Ability to keep the eye open for imaging
- For interventional phase: legal capacity to volunteer and signed informed consent
- For interventional phase: clear corneas and crystalline lens
- For interventional phase: initial visual acuity of 20/80 or better
- For interventional phase: specific MTHFR genotypes with mild to moderate vascular retinopathy
- For interventional phase: Hemoglobin A1c of 10 or less
- For interventional phase: normotensive with or without medications
- For interventional phase: no retinal capillary dropout or macular edema
- For interventional phase: blood homocysteine greater than 9
You will not qualify if you...
- Inability to read and sign informed consent form
- Inability to receive ophthalmic imaging
- Inability to tolerate bright light during imaging
- Presence of active ocular disease
- Eye surgery or injury within 6 months prior to enrollment
Research Team
J
Jianhua Wang, MD, PhD
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