Status:
UNKNOWN
Combined Effects of Diabetes Self-Management Education and Nutritional Supplementation on Visual Function and Retinopathy
Lead Sponsor:
ZeaVision, LLC
Conditions:
Diabetes Mellitus
Diabetic Retinopathy
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the combined effects of diabetes self-management education (DSME) and nutritional supplementation on visual function and retinopathy incidence \& progression i...
Detailed Description
This will be an investigator initiated, multi-center, double-blinded prospective study of 150-200 adult subjects with established prediabetes or diabetes. Subjects will be identified and enrolled with...
Eligibility Criteria
Inclusion
- diagnosed prediabetes, type 1 or type 2 diabetes
- no diabetic retinopathy (DR), mild DR or moderate DR without center-involved macular edema
- age \> 18 years
- ability to give informed consent
- best corrected visual acuity \> 20/30 in each eye.
Exclusion
- no formal diagnosis of prediabetes or diabetes
- age \< 18 years
- inability to give informed consent
- best corrected visual acuity \< 20/30 in either eye
- center-involved DME by spectral domain optical coherence tomography \* evidence of severe non-proliferative or proliferative diabetic retinopathy
- evidence of other serious ocular disease (age-related macular degeneration, glaucoma, significant media opacity)
- history of intraocular surgery, including macular or panretinal photocoagulation or prior intra-ocular injection of anti-Vascular endothelial growth factor (anti-VEGF) drugs (except uncomplicated cataract or keratorefractive surgery more than 6 months prior to enrollment)
- pregnant and nursing women
- known sensitivity to any of the supplement ingredients.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04120077
Start Date
January 1 2020
End Date
January 1 2022
Last Update
April 23 2021
Active Locations (1)
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1
Advantage Vision Center
Charlotte, North Carolina, United States, 28203