Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
Healthy Volunteers
ID03135327

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

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants in the Ocufolin group take medical food capsules daily with meals, increasing dosage over the first two weeks, continuing for 6 months.

Regular visits during the 6 months for monitoring

Long-term Monitoring

Duration - 1 to 2 years

Participants in the observational group are followed up to 1 to 2 years for retinal and ocular health assessments.

Follow-up visits over 1 to 2 years

Trial Site Locations

Total: 1 location

1

Bascom Palmer Eye Institute

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

J

Jianhua Wang, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Frequently Asked Questions

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