Diabetes Visual Function Supplement Study
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Diabetes |
| Therapuetic Areas: | Endocrinology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | May 2012 |
| End Date: | June 2013 |
| Contact: | Alan P. Chous, O.D. |
| Email: | dr.chous@diabeticeyes.com |
| Phone: | 425-736-6251 |
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
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.
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.
Inclusion Criteria:
- diabetes mellitus diagnosed at least 5 years
- age greater than or equal to 18 years
- English speaker
Exclusion Criteria:
- proliferative diabetic retinopathy or severe non-proliferative retinopathy
- clinically significant macular edema
- corrected visual acuity less than 20/30 in either eye
- diagnosis of other serious eye disease (glaucoma, age-related maculopathy)
- less than 18 years old
- non-English speaker
- no known allergy or sensitivity to any supplement ingredients
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