Non-proliferative Diabetic Retinopathy Clinical Trial
Official title:
Effects of a Novel Dietary Supplement on Visual Function in Patients With Diabetes With and Without Early Diabetic Retinopathy
This study will evaluate the effects of a novel multi-component dietary supplement on the
visual function and retinal structure of patients with diabetes with both no diabetic
retinopathy and mild to moderate diabetic retinopathy. This is a placebo-controlled trial
and neither subjects nor examiners will know if any given subject is taking active
supplement or placebo.
The hypothesis is that the supplement will improve visual function and retinal structure in
subjects on active supplement
Adult patients with either type 1 or type 2 diabetes will be enrolled with baseline measurement of visual acuity, contrast sensitivity, color vision, threshold macular perimetry, macular pigment optical density, optical coherence tomography, glycosylated hemoglobin, blood lipids and serum vitamin D status. A multi-component dietary supplement containing ingredients currently available over the counter in the US will be taken for six months and repeat measurements of the above parameters obtained. ;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
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