%0 Journal Article
%T A randomised controlled trial investigating the effect of nutritional supplementation on visual function in normal, and age-related macular disease affected eyes: design and methodology [ISRCTN78467674]
%A Hannah Bartlett
%A Frank Eperjesi
%J Nutrition Journal
%D 2003
%I BioMed Central
%R 10.1186/1475-2891-2-12
%X The aim of this randomised controlled trial is to determine the effect of a nutritional supplement containing lutein, vitamins A, C and E, zinc, and copper on measures of visual function in people with and without age-related macular disease. Outcome measures are distance and near visual acuity, contrast sensitivity, colour vision, macular visual field, glare recovery, and fundus photography. Randomisation is achieved via a random number generator, and masking achieved by third party coding of the active and placebo containers. Data collection will take place at nine and 18 months, and statistical analysis will employ Student's t test.A paucity of treatment modalities for age-related macular disease has prompted research into the development of prevention strategies. A positive effect on normals may be indicative of a role of nutritional supplementation in preventing or delaying onset of the condition. An observed benefit in the age-related macular disease group may indicate a potential role of supplementation in prevention of progression, or even a degree reversal of the visual effects caused by this condition.Age-related macular degeneration is the leading cause of registrable blindness in the developed world [1-3], and its prevalence is expected to increase with the anticipated demographic right-shift [4]. In order to standardise terminology a classification system for age-related macular degeneration has been developed [5]. Early and late stages of the condition are termed age-related maculopathy (ARM) and age-related macular degeneration (AMD) respectively. The term age-related macular disease will be used to encompass ARM and AMD.ARM is most often clinically apparent over the age of 50 years. The main symptom is increasing difficulty with fine detail discrimination. AMD is categorised further in to 'non-neovascular AMD' (also known as dry AMD or geographic atrophy), and 'neovascular AMD' (also known as wet, exudative, or disciform) [5]. Neovascular AMD refers
%U http://www.nutritionj.com/content/2/1/12