Clinical Applications of Advanced Ophthalmic Imaging
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- University of Miami
- Enrollment
- 5000
- Locations
- 1
- Primary Endpoint
- Retinal vasculature by optical coherence tomography angiography (OCTA)
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Jianhua (Jay) Wang, MD, PhD
Professor
University of Miami
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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:
- •Inclusion criteria
- •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;
Outcomes
Primary Outcomes
Retinal vasculature by optical coherence tomography angiography (OCTA)
Time Frame: up to 2 years
Retinal vascular network density in percentage.
Conjunctival vasculature by functional slit-lamp (FSLB)
Time Frame: up to 2 years
Conjunctival vascular network density in percentage.
Retinal microstructure using OCT.
Time Frame: up to 2 years
Optical coherence tomography is used to measure the thickness of intraretinal layers. The measurement is in micrometer.
Tear film thickness
Time Frame: up to 2 years
Measured in micrometers using ultra high resolution OCT
Corneal epithelial thickness
Time Frame: up to 2 years
Measured in micrometers using ultra high resolution OCT
Secondary Outcomes
- Conjunctival blood flow velocity by functional slit-lamp (FSLB)(up to 2 years)
- Retinal blood flow velocity by retinal function imager (RFI)(up to 2 years)