Multicenter ophthalmic and nutritional age-related macular degeneration study--part 1: design, subjects and procedures. Age-related Macular Degeneration Study Group

Abstract

Background: A prospective 18 month, double-blind case-controlled study was designed to determine whether a specific over-the-counter multivitamin/mineral/antioxidant nutrient capsule taken twice daily prevents the progression of, or improves the outcome of non-exudative ARMD. Two randomly assigned experimental ARMD groups are compared to each other, to age matched ARMD-free case controls and to 1994 NHANES III nutritional data.

Methods: Thirty-two dry ARMD patients assigned to group one (placebo) and 39 dry ARMD patients were assigned to group two (Ocuguard, a broad spectrum antioxidant capsule). A third age and sex matched ARMD-free case control group of 13 patients who met the same entrance criteria were also selected. All participants underwent thorough visual and nutritional evaluation prior to initiation of the study. Both ophthalmic tests and dietetic assessments were also performed at 6, 12 and 18 months following a 2-week initiation period.

Results: In comparison to NHANES-III age stratified population data and the Recommended Daily Allowance (but not case controls), the ARMD population manifested decreased intake of nutrients vital to cardiovascular health: vitamin E, magnesium, zinc, vitamin B6 and folic acid. The two randomly assigned experimental groups were well matched, with little difference in baseline demographic, ocular, hematologic and pre-intervention symptoms. There were differences in nutritional intake between the two groups, due primarily to significantly higher percent ideal body weight in group two.