Clinical Applications of Advanced Ophthalmic Imaging
Primary Purpose
Multiple Sclerosis, Dry Eye Syndromes, Diabetic Retinopathy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ocufolin
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Sclerosis
Eligibility Criteria
Observational Phase 1 Group
Inclusion Criteria:
- Self-reported normal healthy subjects;
- Clinical diagnosis of Alzheimer's Disease, mild cognitive impairment, multiple sclerosis, dry eye, myopia, diabetics and stroke;
- Who can keep the eye open for imaging.
Exclusion Criteria:
- who can not read and sign the ICF;
- who can not receiving ophthalmic imaging;
- 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:
- Is at least 18 years old and has full legal capacity to volunteer;
- Has read and signed the IRB Informed Consent Document;
- Is willing and able to follow participant instructions;
- Has clear corneas and crystalline lens;
- Initial visual acuities were 20/80 or better;
- MTHFR C677TT homozygous, or MTHFR C677T/A1298C compound heterozygous with mild to moderate micro-aneurismal vascular retinopathy disease;
- Hemoglobin A1c is 10 or less;
- Normotensive with or without medications;
- Without retinal capillary dropout or macular edema;
- Blood homocysteine > 9.
Exclusion criteria
The subjects will be ineligible for entry into the study if s/he:
- Has an active ocular disease;
- Has had surgery or an eye injury within 6 months.
Sites / Locations
- Bascom Palmer Eye InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional Phase - Ocufolin Group
Observational Phase Group
Arm Description
Participants in this group will receive the Ocufolin medical food for 6 months.
Participants in this group will be studied and followed up for 1-2 years.
Outcomes
Primary Outcome Measures
Retinal microstructure using OCT.
Optical coherence tomography is used to measure the thickness of intraretinal layers. The measurement is in micrometer.
Retinal vasculature by optical coherence tomography angiography (OCTA)
Retinal vascular network density in percentage.
Conjunctival vasculature by functional slit-lamp (FSLB)
Conjunctival vascular network density in percentage.
Corneal epithelial thickness
Measured in micrometers using ultra high resolution OCT
Tear film thickness
Measured in micrometers using ultra high resolution OCT
Secondary Outcome Measures
Retinal blood flow velocity by retinal function imager (RFI)
Retinal blood flow velocity in mm/s
Conjunctival blood flow velocity by functional slit-lamp (FSLB)
Conjunctival blood flow velocity in mm/s
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03135327
Brief Title
Clinical Applications of Advanced Ophthalmic Imaging
Official Title
Clinical Applications of Advanced Ophthalmic Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2007 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Dry Eye Syndromes, Diabetic Retinopathy, Presbyopia, Myopia, Dementia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional Phase - Ocufolin Group
Arm Type
Experimental
Arm Description
Participants in this group will receive the Ocufolin medical food for 6 months.
Arm Title
Observational Phase Group
Arm Type
No Intervention
Arm Description
Participants in this group will be studied and followed up for 1-2 years.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ocufolin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retinal microstructure using OCT.
Description
Optical coherence tomography is used to measure the thickness of intraretinal layers. The measurement is in micrometer.
Time Frame
up to 2 years
Title
Retinal vasculature by optical coherence tomography angiography (OCTA)
Description
Retinal vascular network density in percentage.
Time Frame
up to 2 years
Title
Conjunctival vasculature by functional slit-lamp (FSLB)
Description
Conjunctival vascular network density in percentage.
Time Frame
up to 2 years
Title
Corneal epithelial thickness
Description
Measured in micrometers using ultra high resolution OCT
Time Frame
up to 2 years
Title
Tear film thickness
Description
Measured in micrometers using ultra high resolution OCT
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Retinal blood flow velocity by retinal function imager (RFI)
Description
Retinal blood flow velocity in mm/s
Time Frame
up to 2 years
Title
Conjunctival blood flow velocity by functional slit-lamp (FSLB)
Description
Conjunctival blood flow velocity in mm/s
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Observational Phase 1 Group
Inclusion Criteria:
Self-reported normal healthy subjects;
Clinical diagnosis of Alzheimer's Disease, mild cognitive impairment, multiple sclerosis, dry eye, myopia, diabetics and stroke;
Who can keep the eye open for imaging.
Exclusion Criteria:
who can not read and sign the ICF;
who can not receiving ophthalmic imaging;
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:
Is at least 18 years old and has full legal capacity to volunteer;
Has read and signed the IRB Informed Consent Document;
Is willing and able to follow participant instructions;
Has clear corneas and crystalline lens;
Initial visual acuities were 20/80 or better;
MTHFR C677TT homozygous, or MTHFR C677T/A1298C compound heterozygous with mild to moderate micro-aneurismal vascular retinopathy disease;
Hemoglobin A1c is 10 or less;
Normotensive with or without medications;
Without retinal capillary dropout or macular edema;
Blood homocysteine > 9.
Exclusion criteria
The subjects will be ineligible for entry into the study if s/he:
Has an active ocular disease;
Has had surgery or an eye injury within 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhua Wang, MD, PhD
Phone
3054825010
Email
jwang3@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhua Wang, MD, PhD
Organizational Affiliation
Bascom Palmer Eye Institute, University of Miami, Miami, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Wang, MD, PHD
Phone
305-482-5010
Email
jwang3@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Jianhua Wang, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Applications of Advanced Ophthalmic Imaging
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