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NCT Number: NCT03135327

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Observational Phase 1 Group

Inclusion criteria

  • Self-reported normal healthy subjects;
  • Clinical diagnosis of Alzheimer's Disease, mild cognitive impairment, multiple sclerosis, dry eye, myopia, diabetics and stroke;
  • Who can keep the eye open for imaging.

Exclusion criteria

  • who can not read and sign the ICF;
  • who can not receiving ophthalmic imaging;
  • 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:

  • Is at least 18 years old and has full legal capacity to volunteer;
  • Has read and signed the IRB Informed Consent Document;
  • Is willing and able to follow participant instructions;
  • Has clear corneas and crystalline lens;
  • Initial visual acuities were 20/80 or better;
  • MTHFR C677TT homozygous, or MTHFR C677T/A1298C compound heterozygous with mild to moderate micro-aneurismal vascular retinopathy disease;
  • Hemoglobin A1c is 10 or less;
  • Normotensive with or without medications;
  • Without retinal capillary dropout or macular edema;
  • Blood homocysteine > 9.

Exclusion criteria

The subjects will be ineligible for entry into the study if s/he:

  • Has an active ocular disease;
  • Has had surgery or an eye injury within 6 months.

Treatment and study plan

Ocufolin

Dietary Supplement

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.

Primary outcomes

  1. Retinal microstructure using OCT.

    Time frame: up to 2 years

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

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

    Time frame: up to 2 years

    Retinal vascular network density in percentage.

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

    Time frame: up to 2 years

    Conjunctival vascular network density in percentage.

  4. Corneal epithelial thickness

    Time frame: up to 2 years

    Measured in micrometers using ultra high resolution OCT

  5. Tear film thickness

    Time frame: up to 2 years

    Measured in micrometers using ultra high resolution OCT

Secondary outcomes

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

    Time frame: up to 2 years

    Retinal blood flow velocity in mm/s

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

    Time frame: up to 2 years

    Conjunctival blood flow velocity in mm/s

Study contacts

Contact information is provided by the study sponsor or research team.

Jianhua Wang, MD, PhD

CONTACT

[email protected]

3054825010

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2007
Primary completion
2029
Study completion
2029
First posted
May 1, 2017
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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