Clinical Applications of Advanced Ophthalmic Imaging
Recruiting · NCT03135327 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Miami
View the official record on ClinicalTrials.gov →Interventions studied
Ocufolin
What this trial is about
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.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Bascom Palmer Eye Institute - Miami, Florida, United States