Clinical Applications of Advanced Ophthalmic Imaging

Multiple Sclerosis Clinical Trial

Official title:

Clinical Applications of Advanced Ophthalmic Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03135327
• Other study ID #: 20070492
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2007
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: University of Miami
• Contact: Jianhua Wang, MD, PhD
• Phone: 3054825010
• Email: jwang3[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Diabetic Retinopathy
• Dry Eye Syndromes
• Multiple Sclerosis
• Myopia
• Presbyopia

Intervention

Dietary Supplement:
• Ocufolin
Ocufolin medical food capsules will be taken once a day by mouth each morning with a meal for the first week, two capsules orally each morning with a meal for the second week and three capsules orally each morning with a meal for the rest of the 6 months study duration.

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal microstructure using OCT.	Optical coherence tomography is used to measure the thickness of intraretinal layers. The measurement is in micrometer.	up to 2 years
Primary	Retinal vasculature by optical coherence tomography angiography (OCTA)	Retinal vascular network density in percentage.	up to 2 years
Primary	Conjunctival vasculature by functional slit-lamp (FSLB)	Conjunctival vascular network density in percentage.	up to 2 years
Primary	Corneal epithelial thickness	Measured in micrometers using ultra high resolution OCT	up to 2 years
Primary	Tear film thickness	Measured in micrometers using ultra high resolution OCT	up to 2 years
Secondary	Retinal blood flow velocity by retinal function imager (RFI)	Retinal blood flow velocity in mm/s	up to 2 years
Secondary	Conjunctival blood flow velocity by functional slit-lamp (FSLB)	Conjunctival blood flow velocity in mm/s	up to 2 years