Clinical Applications of Advanced Ophthalmic Imaging

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Diabetic Retinopathy; Dementia; Dry Eye Syndromes; Presbyopia; Myopia
• Intervention / Treatment: Dietary supplement: Ocufolin

• Study Type: Interventional
• Enrollment (Estimated): 5000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianhua Wang, MD, PhD; Phone Number: 3054825010; Email: jwang3@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • Bascom Palmer Eye Institute
      • Contact: Jianhua Wang, MD, PHD; Phone Number: 305-482-5010; Email: jwang3@med.miami.edu
      • Principal Investigator: Jianhua Wang, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Phase - Ocufolin Group; Participants in this group will receive the Ocufolin medical food for 6 months.	Dietary supplement: Ocufolin; Ocufolin medical food capsules will be taken once a day by mouth each morning with a meal for the first week, two capsules orally each morning with a meal for the second week and three capsules orally each morning with a meal for the rest of the 6 months study duration.
No Intervention: Observational Phase Group; Participants in this group will be studied and followed up for 1-2 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal microstructure using OCT.	Optical coherence tomography is used to measure the thickness of intraretinal layers. The measurement is in micrometer.	up to 2 years
Retinal vasculature by optical coherence tomography angiography (OCTA)	Retinal vascular network density in percentage.	up to 2 years
Conjunctival vasculature by functional slit-lamp (FSLB)	Conjunctival vascular network density in percentage.	up to 2 years
Corneal epithelial thickness	Measured in micrometers using ultra high resolution OCT	up to 2 years
Tear film thickness	Measured in micrometers using ultra high resolution OCT	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal blood flow velocity by retinal function imager (RFI)	Retinal blood flow velocity in mm/s	up to 2 years
Conjunctival blood flow velocity by functional slit-lamp (FSLB)	Conjunctival blood flow velocity in mm/s	up to 2 years

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Jianhua Wang, MD, PhD, Bascom Palmer Eye Institute, University of Miami, Miami, FL

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2007
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Autoimmune Diseases; Immune System Diseases; Diabetes Mellitus; Eye Diseases; Diabetic Angiopathies; Diabetes Complications; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Refractive Errors; Lacrimal Apparatus Diseases; Retinal Diseases; Diabetic Retinopathy; Multiple Sclerosis; Dry Eye Syndromes; Presbyopia
• Other Study ID Numbers: 20070492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No