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

What Was Tested

Researchers studied Antioxidants in this randomized controlled trial publication.

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.

Who Took Part

The study group was 6 subjects.

By PubMed's age tags, the people studied were middle-aged adults, older adults and people over 80, both men and women.

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.

How the Study Was Run

In design terms this was a randomized, double-blind and placebo-controlled study.

Random assignment meant chance, not the researchers, decided who got Antioxidants and who got the comparison, which limits bias.

As a double-blind Antioxidants study, the assignments were hidden from both participants and investigators until the end.

Some subjects received a placebo instead of Antioxidants, giving a reference point.

What Was Measured

PubMed files the paper under topics including Antioxidants, Case-Control Studies, Contrast Sensitivity, Dietary Supplements, Fatty Acids, Omega-3, Fluorescein Angiography and Fundus Oculi.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Antioxidants in 6 subjects.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2007 (BMC ophthalmology), a journal based in England.

More context: all human trials.