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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Phase - Ocufolin Group | Experimental | Participants in this group will receive the Ocufolin medical food for 6 months. |
|
| Observational Phase Group | No Intervention | Participants in this group will be studied and followed up for 1-2 years. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal microstructure using OCT. | Optical coherence tomography is used to measure the thickness of intraretinal layers. The measurement is in micrometer. | up to 2 years |
| Retinal vasculature by optical coherence tomography angiography (OCTA) | Retinal vascular network density in percentage. | up to 2 years |
| Conjunctival vasculature by functional slit-lamp (FSLB) | Conjunctival vascular network density in percentage. | up to 2 years |
| Corneal epithelial thickness | Measured in micrometers using ultra high resolution OCT | up to 2 years |
| Tear film thickness | Measured in micrometers using ultra high resolution OCT | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal blood flow velocity by retinal function imager (RFI) | Retinal blood flow velocity in mm/s | up to 2 years |
| Conjunctival blood flow velocity by functional slit-lamp (FSLB) | Conjunctival blood flow velocity in mm/s |
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Observational Phase 1 Group
Inclusion Criteria:
Exclusion Criteria:
Interventional Phase 2 Group:
Inclusion criteria
The participant will be eligible for entry in the study if s/he:
Exclusion criteria
The subjects will be ineligible for entry into the study if s/he:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianhua Wang, MD, PhD | Contact | 3054825010 | jwang3@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jianhua Wang, MD, PhD | Bascom Palmer Eye Institute, University of Miami, Miami, FL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bascom Palmer Eye Institute | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D015352 | Dry Eye Syndromes |
| D003930 | Diabetic Retinopathy |
| D011305 | Presbyopia |
| D009216 | Myopia |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C000711993 | Ocufolin |
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|
| up to 2 years |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D012030 | Refractive Errors |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |