Clinical trial NCT03135327: Clinical Applications of Advanced Ophthalmic Imaging
Official title: Clinical Applications of Advanced Ophthalmic Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Dry Eye Syndromes
Diabetic Retinopathy
Presbyopia
Myopia
Dementia
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Primary outcomes:
measure: Retinal microstructure using OCT.
timeFrame: up to 2 years
measure: Retinal vasculature by optical coherence tomography angiography (OCTA)
timeFrame: up to 2 years
measure: Conjunctival vasculature by functional slit-lamp (FSLB)
timeFrame: up to 2 years
measure: Corneal epithelial thickness
timeFrame: up to 2 years
measure: Tear film thickness
timeFrame: up to 2 years
Secondary outcomes:
measure: Retinal blood flow velocity by retinal function imager (RFI)
timeFrame: up to 2 years
measure: Conjunctival blood flow velocity by functional slit-lamp (FSLB)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
Study officials:
affiliation: Bascom Palmer Eye Institute, University of Miami, Miami, FL
name: Jianhua Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: