Thursday, March 6. 2008
TOZAL Study: An open case control study of an oral antioxidant and omega-3 supplement for dry AMD Published: 26 February 2007 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. BMC Ophthalmology 2007, 7:3 doi:10.1186/1471-2415-7-3
Received: 6 November 2006
Accepted: 26 February 2007
This article is available from: http://www.biomedcentral.com/1471-2415/7/3
© 2007 Cangemi; licensee BioMed Central Ltd.Abstract Background: The primary objective of this prospective study was to measure the change from baseline in visual function – Best-Corrected Visual Acuity (BCVA) via the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, contrast sensitivity, central 10 degree visual fields and retinalimaging (angiograms and photographs) at 6 months in subjects with atrophic (dry) age-relatedmacular degeneration treated with a targeted nutritional supplement.Methods: 37 mixed gender patients with a mean age of 76.3 +/- 7.8 years were enrolled at 5independent study sites and received standard of care with a novel formulation of a nutritional supplement. Results were compared to a placebo cohort constructed from the literature that wasmatched for inclusion and exclusion criteria. A paired t-test was used to test a null hypothesis anda two-sided alpha level of 0.05 was used to determine statistical significance.Results: 76.7% of subjects receiving the nutritional supplement demonstrated stabilization or improvement of BCVA at 6 months. Subjects gained an average of 0.0541 logMAR or one-half of a line of visual acuity (VA) over the 6-month period. There was a statistically significant improvement in VA from baseline with P = .045. The results provide strong evidence that the treatment being studied produces an improvement in VA.Conclusion: ---------------------------------------------------------------------------- Order AmeriSciences TOZAL for Macular Degeneration and Vision Support. http://www.wellnessforlifecenter.org/vision.shtml Treatment with this unique nutritional supplement increased VA above the expected baseline decrease in the majority of patients in this population with dry macular degeneration. The results of the TOZAL study agree with the LAST and CARMIS studies and are predictive for positive visual acuity outcomes in the AREDS II trial. However, patients will likely require supplementation for longer than 6 months to effect changes in additional visual parameters.Francis E Cangemi*
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