The effect of a lutein based nutritional supplement on non-exudative age-related macular degeneration (AMD): a double-masked randomised controlled trial

Aston University (UK)0 个研究点目标入组 159 人开始时间: 2003年9月11日最近更新: 2018年2月12日

适应症

试验速览

•1. Have to provide written informed consent
•2. Have to be available for three visits to Aston University
•3. Have to present with no ocular pathology in one eye, or no ocular pathology other than dry AMD in one eye. A cataract grading system consisting of grades one, two and three for each of cortical, nuclear, and posterior subcapsular cataracts has been developed. Participants presenting with lens opacities precluding fundus photography are excluded. Throughout the trial period, progression of any type of cataract to the successive grade will require the participant to withdraw.; 1. Have to provide written informed consent
•2. Have to be available for three visits to Aston University
•3. Have to present with no ocular pathology in one eye, or no ocular pathology other than dry AMD in one eye. A cataract grading system consisting of grades one, two and three for each of cortical, nuclear, and posterior subcapsular cataracts has been developed. Participants presenting with lens opacities precluding fundus photography are excluded. Throughout the trial period, progression of any type of cataract to the successive grade will require the participant to withdraw.

•Exclusion criteria include type I and II diabetes because vitamin E has been shown to affect glucose tolerance and diabetic retinopathy may confound the results. Those taking Warfarin medication are excluded as zinc may decrease its absorption and activity, as are those who use nutritional supplements that potentially raise vitamin and mineral intake above safe limits. The most recent guidelines for upper limits of nutritional supplementation are set out in the UK Food Standards Agency report. Neovascular AMD and other ocular disease that could potentially interfere with the results are excluded.; Exclusion criteria include type I and II diabetes because vitamin E has been shown to affect glucose tolerance and diabetic retinopathy may confound the results. Those taking Warfarin medication are excluded as zinc may decrease its absorption and activity, as are those who use nutritional supplements that potentially raise vitamin and mineral intake above safe limits. The most recent guidelines for upper limits of nutritional supplementation are set out in the UK Food Standards Agency report. Neovascular AMD and other ocular disease that could potentially interfere with the results are excluded.

发起方

Aston University (UK)