Dataset Information

TOZAL Study: an open case control study of an oral antioxidant and omega-3 supplement for dry AMD.

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 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.

SUBMITTER: Cangemi FE

PROVIDER: S-EPMC1831760 | biostudies-literature | 2007 Feb

REPOSITORIES: biostudies-literature

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Publications

TOZAL Study: an open case control study of an oral antioxidant and omega-3 supplement for dry AMD.

Cangemi Francis E FE

BMC ophthalmology 20070226

<h4>Background</h4>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.<h4>Methods</h4>37 mixed gender patients wit ...[more]

PMID: 17324285

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Dataset Information

TOZAL Study: an open case control study of an oral antioxidant and omega-3 supplement for dry AMD.

Background

Methods

Results

Conclusion

Publications

TOZAL Study: an open case control study of an oral antioxidant and omega-3 supplement for dry AMD.

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