Clinical Applications of Advanced Ophthalmic Imaging

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT03135327
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Jan 1, 2007
Status verified
Aug 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
5,000 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Interventional Phase - Ocufolin Group
    Participants in this group will receive the Ocufolin medical food for 6 months.
  • No Intervention: Observational Phase Group
    Participants in this group will be studied and followed up for 1-2 years.

Primary Outcome Measure

Retinal microstructure using OCT. [ Time Frame: up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Bascom Palmer Eye InstituteMiamiFlorida33136
Jianhua Wang, MD, PHD
[email protected]
305-482-5010
Jianhua Wang, MD, PhD (PRINCIPAL_INVESTIGATOR)

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