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The Diabetes Visual Function Supplement Study (DiVFuSS)
  1. A Paul Chous1,
  2. Stuart P Richer2,
  3. Jeffry D Gerson3,
  4. Renu A Kowluru4
  1. 1Private Practice, Tacoma, Washington, USA
  2. 2Captain James A Lovell Federal Heath Care Center, North Chicago, Illinois, USA
  3. 3Private Practice, Olathe, Kansas, USA
  4. 4Kresge Eye Institute, Wayne State University, Detroit, Michigan, USA
  1. Correspondence to Dr A Paul Chous, FAAO, 6720 Regents Blvd., Tacoma, WA 98466, USA; dr.chous{at}diabeticeyes.com

Abstract

Background Diabetes is known to affect visual function before onset of retinopathy (diabetic retinopathy (DR)). Protection of visual function may signal disruption of mechanisms underlying DR.

Methods This was a 6-month randomised, controlled clinical trial of patients with type 1 and type 2 diabetes with no retinopathy or mild to moderate non-proliferative retinopathy assigned to twice daily consumption of placebo or a novel, multi-component formula containing xanthophyll pigments, antioxidants and selected botanical extracts. Measurement of contrast sensitivity, macular pigment optical density, colour discrimination, 5-2 macular threshold perimetry, Diabetic Peripheral Neuropathy Symptoms, foveal and retinal nerve fibre layer thickness, glycohaemoglobin (HbA1c), serum lipids, 25-OH-vitamin D, tumour necrosis factor α (TNF-a) and high-sensitivity C reactive protein (hsCRP) were taken at baseline and 6 months. Outcomes were assessed by differences between and within groups at baseline and at study conclusion using meand ± SDs and t tests (p<0.05) for continuous variables.

Results There were no significant intergroup differences at baseline. At 6 months, subjects on active supplement compared with placebo had significantly better visual function on all measures (p values ranging from 0.008 to <0.0001), significant improvements in most serum lipids (p values ranging from 0.01 to 0.0004), hsCRP (p=0.01) and diabetic peripheral neuropathy (Fisher's exact test, p=0.0024) No significant changes in retinal thickness, HbA1c, total cholesterol or TNF-α were found between the groups.

Conclusions This study provides strong evidence of clinically meaningful improvements in visual function, hsCRP and peripheral neuropathy in patients with diabetes, both with and without retinopathy, and without affecting glycaemic control.

Trial registration number www.ClinicalTrials.gov Identifier: NCT01646047

  • Clinical Trial
  • Macula
  • Field of vision
  • Colour vision
  • Retina

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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