Dementia, Diabetic Retinopathy, Dry Eye Syndromes, Multiple Sclerosis, Myopia, Presbyopia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTOcufolin
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.
Sponsors
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
Observational Phase 1 Group 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.
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: Inclusion criteria 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retinal microstructure using OCT. | up to 2 years | Optical coherence tomography is used to measure the thickness of intraretinal layers. The measurement is in micrometer. |
| Retinal vasculature by optical coherence tomography angiography (OCTA) | up to 2 years | Retinal vascular network density in percentage. |
| Conjunctival vasculature by functional slit-lamp (FSLB) | up to 2 years | Conjunctival vascular network density in percentage. |
| Corneal epithelial thickness | up to 2 years | Measured in micrometers using ultra high resolution OCT |
| Tear film thickness | up to 2 years | Measured in micrometers using ultra high resolution OCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retinal blood flow velocity by retinal function imager (RFI) | up to 2 years | Retinal blood flow velocity in mm/s |
| Conjunctival blood flow velocity by functional slit-lamp (FSLB) | up to 2 years | Conjunctival blood flow velocity in mm/s |
Countries
United States
Contacts
CONTACTJianhua Wang, MD, PhD
PRINCIPAL_INVESTIGATORJianhua Wang, MD, PhD
Bascom Palmer Eye Institute, University of Miami, Miami, FL
Outcome results
None listed