NCT03135327 Clinical Applications of Advanced Ophthalmic Imaging
| NCT ID | NCT03135327 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Miami |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2007-01-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5,000 participants in total. It began in 2007-01-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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. Exclusion criteria The subjects will be ineligible for entry into the study if s/he: 1. Has an active ocular disease; 2. Has had surgery or an eye injury within 6 months.
Contact & Investigator
Jianhua Wang, MD, PhD
PRINCIPAL INVESTIGATOR
Bascom Palmer Eye Institute, University of Miami, Miami, FL
Frequently Asked Questions
Who can join the NCT03135327 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03135327 currently recruiting?
Yes, NCT03135327 is actively recruiting participants. Contact the research team at jwang3@med.miami.edu for enrollment information.
Where is the NCT03135327 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT03135327 clinical trial?
NCT03135327 is sponsored by University of Miami. The principal investigator is Jianhua Wang, MD, PhD at Bascom Palmer Eye Institute, University of Miami, Miami, FL. The trial plans to enroll 5,000 participants.
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