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B. Mustapha, P. Faure, D. Malvy, J. Magnette, N. Bles, F. Koenig-Supiot; Clinical and Biological Parameters to Evaluate Sélénium's Activity in ARMD . Invest. Ophthalmol. Vis. Sci. 2003;44(13):1797.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose:Methods: A pilot, monocenter, double masked, placebo controlled, randomized clinical trial. 0 ,960 mg /per os( selenium) versus placebo. 96 eyes in 48 patients with ARMD (drusen without any neovascular complications). 24 month follow up , with a control every 3 months the first year and 6 months the second year. Control with measurement of visual acuity (ETDRS chart), contrast sensitivity ( Pelli Robson), color vision (Farnsworth 15), macular field (Rodenstock/Péristat), drusen area (SLO/Zeiss), biology (selenium, thiols,glutathion peroxydase,malonaldehyde ; A,C,E vitamins ; carbonyls, carotene). Results: Increasing selenium's blood level in treated group (1,5 micro mol/l) At 3 months follow up : higher level of visual acuity (ETDRS score) in the treated group (p=0.0254), and also contrast sensitivy's level (p=0.0434) than the placebo group. This is a clinical aspect of selenium known stimulant effect. At 24 months follow up : contrast sensitivity's level is higher in treated group (p=0.0457), evolution of macular field (p=0.02) is also better than in placebo group. There was not difference in the others parameters, the mean decrease of visual acuity was 8 letters in both groups. Drusen area measurement using SLO is on going. Conclusions: This pilot study demonstrate the stimulant effect of selenium à 3 months follow up in term of better visual acuity ,contrast sensitivity and a increase of glutathion peroxydase activity. A significant difference was noted in contrast sensitivy and macular field levels at 24 months follow up, in the treated group. There was also strong correlation between the clinical parameters and the glutathion peroxydase's activity ( Delta score=0.0937). This first results needs to be completed in a multicenter study with a higher number of patients and à better understanding between clinical and biological effects.
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