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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
5,000
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.
Bascom Palmer Eye Institute
Miami, Florida, United States
RECRUITINGRetinal 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
Retinal vasculature by optical coherence tomography angiography (OCTA)
Retinal vascular network density in percentage.
Time frame: up to 2 years
Conjunctival vasculature by functional slit-lamp (FSLB)
Conjunctival vascular network density in percentage.
Time frame: up to 2 years
Corneal epithelial thickness
Measured in micrometers using ultra high resolution OCT
Time frame: up to 2 years
Tear film thickness
Measured in micrometers using ultra high resolution OCT
Time frame: up to 2 years
Retinal blood flow velocity by retinal function imager (RFI)
Retinal blood flow velocity in mm/s
Time frame: up to 2 years
Conjunctival blood flow velocity by functional slit-lamp (FSLB)
Conjunctival blood flow velocity in mm/s
Time frame: up to 2 years
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