Heavy Traffic Ahead: Car Culture Accelerates

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 retinal imaging (angiograms and photographs) at 6 months in subjects with atrophic (dry) age-related macular 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 5 independent 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 was matched for inclusion and exclusion criteria. A paired t-test was used to test a null hypothesis and a 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: 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. Background Age-related Macular Degeneration (AMD) is a progressive disorder associated with central vision loss and is the leading cause of visual impairment and blindness in people over the age of 60. More than 15 million Americans over the age of 60 have AMD with an additional 50 million Americans at risk for developing the disorder [1]. Dry, atrophic, or non-exudative, AMD is the most common form and is characterized by progressive devitalization of retinal pigment epithelium (RPE) and the formation of fatty deposits under the RPE known as soft drusen [1]. Although the underlying cause of AMD is unknown, risk factors have been defined and include age greater than 50, Caucasian race, nutrition, smoking, atherosclerotic vascuPublished: 26 February 2007 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. 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.