Clinical Applications of Advanced Ophthalmic Imaging

Who is this study for? Patients with Multiple Sclerosis, Dry Eye Syndromes, Diabetic Retinopathy, Presbyopia, Myopia, Dementia
What treatments are being studied? Ocufolin
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:

• 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.

‣ 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.

Locations
United States
Florida
Bascom Palmer Eye Institute
RECRUITING
Miami
Contact Information
Primary
Jianhua Wang, MD, PhD
jwang3@med.miami.edu
3054825010
Time Frame
Start Date: 2007-01-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 5000
Treatments
Experimental: Interventional Phase - Ocufolin Group
Participants in this group will receive the Ocufolin medical food for 6 months.
No_intervention: Observational Phase Group
Participants in this group will be studied and followed up for 1-2 years.
Sponsors
Leads: University of Miami

This content was sourced from clinicaltrials.gov