Combined Effects of Diabetes Self-Management Education and Nutritional Supplementation on Visual Function and Retinopathy
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Diabetes Mellitus, Diabetic Retinopathy
In brief
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 in patients with type 1 diabetes, type 2 diabetes and pre-diabetes.
Key facts
- Study ID
- NCT04120077
- Run by
- ZeaVision, LLC
- People needed
- 150
- Starts
- 2020-01-01
- Expected to finish
- 2022-01-01
- Last updated by the study team
- 2021-04-23
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Advantage Vision Center — Charlotte, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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