Clinical Applications of Advanced Ophthalmic Imaging

NCT03135327 | Recruiting

• 1 other identifier: 20070492
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis; Dry Eye Syndromes; Diabetic Retinopathy; Presbyopia; Myopia; Dementia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Retinal blood flow velocity by retinal function imager (RFI)

  up to 2 years

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

  up to 2 years

Study Arms (2)

Interventional Phase - Ocufolin Group

EXPERIMENTAL

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

Dietary Supplement: Ocufolin

Observational Phase Group

NO INTERVENTION

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

Interventions

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.

Interventional Phase - Ocufolin Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Dry Eye Syndromes; Diabetic Retinopathy; Presbyopia; Myopia; Dementia

Interventions

Ocufolin

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Refractive Errors; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jianhua Wang, MD, PhD

  Bascom Palmer Eye Institute, University of Miami, Miami, FL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianhua Wang, MD, PhD

CONTACT

3054825010; jwang3@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 1, 2017
• Study Start: January 1, 2007
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)