Clinical trial NCT01646047: Diabetes Visual Function Supplement Study
Official title: Effects of a Novel Dietary Supplement on Visual Function in Patients With Diabetes With and Without Early Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus - Type 1
Diabetes Mellitus - Type 2
Non-proliferative Diabetic Retinopathy
Keywords: diabetes
diabetic retinopathy
nutritional supplements
visual function
macular pigment
macular threshold sensitivity
contrast sensitivity
color vision
optical coherence tomography
Lead sponsor: ZeaVision, LLC
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in visual function
timeFrame: At baseline and again at six months
Secondary outcomes:
measure: Changes in serum markers
timeFrame: At baseline and again at six months
measure: Changes in retinal structure
timeFrame: At baseline and again at 6 months
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Chous Eye Care Associates
state: Washington
Study officials:
affiliation: Chous Eye Care Associates
name: Alan P. Chous, O.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robertson NU, Schoonees A, Brand A, Visser J. Pine bark (Pinus spp.) extract for treating chronic disorders. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD008294. doi: 10.1002/14651858.CD008294.pub5.
citation: Chous AP, Richer SP, Gerson JD, Kowluru RA. The Diabetes Visual Function Supplement Study (DiVFuSS). Br J Ophthalmol. 2016 Feb;100(2):227-34. doi: 10.1136/bjophthalmol-2014-306534. Epub 2015 Jun 18.