Clinical Applications of Advanced Ophthalmic Imaging
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
who can not read and sign the ICF;
who can not receiving ophthalmic imaging;
who cannot tolerate bright light during imaging.
Is at least 18 years old and has full legal capacity to volunteer;
Trial design
Design model
Parallel
Treatments tested in this trial
Ocufolin
Dietary supplementOcufolin 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.
Treatment groups
5,000 Participants
are divided into 2 treatment groupsGroup A: Interventional Phase - Ocufolin GroupExperimental treatment 1 intervention
Group B: Observational Phase GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Retinal 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 years2
Retinal vasculature by optical coherence tomography angiography (OCTA)
Retinal vascular network density in percentage.
Time frame
up to 2 years3
Conjunctival vasculature by functional slit-lamp (FSLB)
Conjunctival vascular network density in percentage.
Time frame
up to 2 years4
Corneal epithelial thickness
Measured in micrometers using ultra high resolution OCT
Time frame
up to 2 yearsSecondary outcomes
1
Retinal blood flow velocity by retinal function imager (RFI)
Retinal blood flow velocity in mm/s
Time frame
up to 2 years2
Conjunctival blood flow velocity by functional slit-lamp (FSLB)
Conjunctival blood flow velocity in mm/s
Time frame
up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov