PURPOSE. To describe the methodological features of a prospective interventional study, examining the effects of anti-oxidant supplementation on progression of lens opacities and ARM. METHODS: VECAT is a four year, prospective double masked, randomised, placebo controlled clinical trial. 1200 participants aged 55-80 yrs have been recruited from the general population in Melbourne, and randomised to Vitamin E (500 i.u daily) or placebo. Study procedures include; 1) assessment of primary end points by serial clinical grading of lens opacities and macular pathology, NIDEK EAS-1000 digital image analysis of lens opacities, and NIDEK 3D/X stereo macular photography, 2) assessment of secondary end points by serial LogMAR visual acuity and VF-14 visual function questionnaire, 3) collection of historical data relating to known risk factors for cataract and 4) collection of data to assess adverse effects attributable to study medication. RESULTS: VECAT has recruited the baseline population of 1200 participants from the general community. Recruitment statistics and baseline clinical characteristics are presented elsewhere. CONCLUSIONS: Any intervention to reduce cataract or ARM would have enormous benefits. Evidence suggesting a role for anti-oxidants comes largely from animal studies and human observational studies. This needs to be tested by prospective large scale studies such as VECAT.
|Original language||English (US)|
|Journal||Investigative Ophthalmology and Visual Science|
|State||Published - Feb 15 1996|