Clinical Applications of Advanced Ophthalmic Imaging

Not Applicable

Recruiting

• Conditions: Dry Eye Syndromes; Presbyopia; Diabetic Retinopathy; Multiple Sclerosis; Myopia; Dementia
• Interventions: Dietary Supplement: Ocufolin

• Registration Number: NCT03135327
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-01-01
• Study First Submitted: 2017-04-24
• Study First Submitted QC: 2017-04-28
• Study First Posted: 2017-05-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-14
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Phase - Ocufolin Group	Ocufolin	Participants in this group will receive the Ocufolin medical food for 6 months.

Primary Outcome Measures

Name	Time	Method
Retinal vasculature by optical coherence tomography angiography (OCTA)	up to 2 years	Retinal vascular network density in percentage.
Conjunctival vasculature by functional slit-lamp (FSLB)	up to 2 years	Conjunctival vascular network density in percentage.
Retinal microstructure using OCT.	up to 2 years	Optical coherence tomography is used to measure the thickness of intraretinal layers. The measurement is in micrometer.
Tear film thickness	up to 2 years	Measured in micrometers using ultra high resolution OCT
Corneal epithelial thickness	up to 2 years	Measured in micrometers using ultra high resolution OCT

Secondary Outcome Measures

Name	Time	Method
Conjunctival blood flow velocity by functional slit-lamp (FSLB)	up to 2 years	Conjunctival blood flow velocity in mm/s
Retinal blood flow velocity by retinal function imager (RFI)	up to 2 years	Retinal blood flow velocity in mm/s

Trial Locations

Locations (1)

Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States