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RecruitingNCT03135327Updated Sep 16, 2026

Clinical Applications of Advanced Ophthalmic Imaging

An interventional study of Ocufolin in Multiple Sclerosis, Dry Eye Syndromes and Diabetic Retinopathy, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by University of Miami · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
5,000
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Multiple Sclerosis
  • Dry Eye Syndromes
  • Diabetic Retinopathy
  • Presbyopia
  • Myopia
  • Dementia
03

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5,000 participants (estimated)

Study arms

  • Experimental
    Interventional Phase - Ocufolin Group

    Participants in this group will receive the Ocufolin medical food for 6 months.

    Dietary Supplement: Ocufolin

  • No intervention
    Observational Phase Group

    Participants in this group will be studied and followed up for 1-2 years.

Interventions

  • Dietary supplementOcufolin

    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.

05

What researchers measure

Primary outcomes

  1. Retinal microstructure using OCT.

    Optical coherence tomography is used to measure the thickness of intraretinal layers. The measurement is in micrometer.

    Time frame: up to 2 years

  2. Retinal vasculature by optical coherence tomography angiography (OCTA)

    Retinal vascular network density in percentage.

    Time frame: up to 2 years

  3. Conjunctival vasculature by functional slit-lamp (FSLB)

    Conjunctival vascular network density in percentage.

    Time frame: up to 2 years

  4. Corneal epithelial thickness

    Measured in micrometers using ultra high resolution OCT

    Time frame: up to 2 years

  5. Tear film thickness

    Measured in micrometers using ultra high resolution OCT

    Time frame: up to 2 years

Secondary outcomes

  1. Retinal blood flow velocity by retinal function imager (RFI)

    Retinal blood flow velocity in mm/s

    Time frame: up to 2 years

  2. Conjunctival blood flow velocity by functional slit-lamp (FSLB)

    Conjunctival blood flow velocity in mm/s

    Time frame: up to 2 years

06

Study locations

1 of 1 sites recruiting
  • Bascom Palmer Eye Institute
    Miami, Florida 33136, United States
    • Jianhua Wang, MD, PHD · Contact · jwang3@med.miami.edu · 305-482-5010
    • Jianhua Wang, MD, PhD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03135327
Lead sponsor
University of Miami
Responsible party
Jianhua (Jay) Wang, MD, PhD (Professor, University of Miami) — Principal investigator
First posted
May 1, 2017
Start date
Jan 1, 2007
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Sep 16, 2026

Study contacts

Jianhua Wang, MD, PhD
Contact
jwang3@med.miami.edu
3054825010
Jianhua Wang, MD, PhD
principal investigator · Bascom Palmer Eye Institute, University of Miami, Miami, FL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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