Clinical Applications of Advanced Ophthalmic Imaging

NCT ID: NCT03135327

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-01
• Study Completion Date: 2029-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Interventional Phase - Ocufolin Group

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

Group Type: EXPERIMENTAL

Ocufolin

Intervention Type: 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.

Observational Phase Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

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

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:

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Jianhua (Jay) Wang, MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianhua Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Bascom Palmer Eye Institute

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jianhua Wang, MD, PhD

Role: CONTACT

jwang3@med.miami.edu

3054825010

Facility Contacts

Jianhua Wang, MD, PHD

Role: primary

jwang3@med.miami.edu

305-482-5010

Other Identifiers

20070492

Identifier Type: -

Identifier Source: org_study_id