Clinical Applications of Advanced Ophthalmic Imaging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ocufolin.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Dry Eye Syndromes, Diabetic Retinopathy, Presbyopia. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 supplement Ocufolin
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.
Primary outcome measures
- Retinal microstructure using OCT. [Time frame: up to 2 years]
- Retinal vasculature by optical coherence tomography angiography (OCTA) [Time frame: up to 2 years]
- Conjunctival vasculature by functional slit-lamp (FSLB) [Time frame: up to 2 years]
- Corneal epithelial thickness [Time frame: up to 2 years]
- Tear film thickness [Time frame: up to 2 years]
Secondary outcome measures (2)
- Retinal blood flow velocity by retinal function imager (RFI) [Time frame: up to 2 years]
- Conjunctival blood flow velocity by functional slit-lamp (FSLB) [Time frame: up to 2 years]
Eligibility criteria
Observational Phase 1 Group
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;
- Initial visual acuities were 20/80 or better;
- MTHFR C677TT homozygous, or MTHFR C677T/A1298C compound heterozygous with mild to moderate micro-aneurismal vascular retinopathy disease;
- Hemoglobin A1c is 10 or less;
- Normotensive with or without medications;
- Without retinal capillary dropout or macular edema;
- Blood homocysteine > 9.
Exclusion criteria
The subjects will be ineligible for entry into the study if s/he:
- Has an active ocular disease;
- Has had surgery or an eye injury within 6 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Bascom Palmer Eye Institute — Miami
Identifiers
NCT: NCT03135327 · 20070492