Clinical Applications of Advanced Ophthalmic Imaging

Launched by UNIVERSITY OF MIAMI · Apr 28, 2017

Keywords

ClinConnect Summary

This clinical trial is exploring how advanced eye imaging technologies, like optical coherence tomography (OCT), can help us understand eye conditions related to diseases such as multiple sclerosis, diabetic retinopathy, and dementia. The study has two main parts. The first part observes the eyes of people with various conditions and compares them to healthy individuals. The second part looks at how the eyes change after participants take an over-the-counter medical food called Ocufolin for six months.

To participate, you should be at least 18 years old and able to follow instructions. You might be eligible if you have conditions like mild cognitive impairment or diabetes, and your eyesight is reasonably good. Participants can expect to undergo eye imaging tests and, during the second phase, take Ocufolin while being monitored for any changes in their eye health. This study is currently looking for volunteers, and it’s important to note that participants should not have any active eye diseases or recent eye injuries.

Gender

ALL

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.