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C. K. Brinkmann, S. P. Rothenbuehler, U. E. K. Wolf-Schnurrbusch, S. Wolf; Enhancement of Macular Pigment by Oral Lutein Supplementation Study (EMPOLS): First Results. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1708.
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Oral Supplementation with Lutein seems an easy means to enhance macular pigment density at the fovea. The patient with risk or early signs of age-related macular degeneration (ARMD) hopes to prevent the development of the disease. So far neither the mechanisms of bioavailability, metabolism and build-up of Lutein at the fovea, nor the actual impact on macular protection, visual function and contrast sensitivity has been fully clarified. The EMPOLS Study aims at a comprehensive understanding of Lutein as a possible ARMD protector.
Supplementation group (SG): 40 subjects (22f, 18m; age: 76±8 yrs) with early signs of ARMD in the study eye (Stages 1a to 3 according to Rotterdam classification) were included. They were supplemented with non-ester 10mg of Lutein for six months. Macular Pigment density (MPD) was measured within a 1° diameter foveal circle by 2-wavelength-autofluorescence-densitometry using the modified HRA (Heidelberg Engineering, Dossenheim, Germany) at Baseline visit (BL), Month 1 (M1), Month 3 (M3) und Month 6 (M6). A matched control group (CG) not taking supplements consisted of 20 subjects (12f, 8m; age: 74±9 yrs). Alongside, serum Lutein levels, best corrected visual acuity (BCVA), Pelli-Robson contrast sensitivity (PR-CS) were evaluated.
Mean±SD MPD in the SG was 0.58±0.2 DU (density units) at BL, 0.64±0.2 DU at M1, 0.63±0.2 at M3, 0.67±0.21 DU at M6. MPD in the CG was 0.51±0.2 DU at BL and 0.58±0.2 DU at M6. Only the MPD increase in the SG was statistically significant (p<0.05). Serum Carotenoid levels did not show direct correlation to foveal MPD in both groups. BCVA remained stable in both groups from BL till M6 (SG: 79±10 letters at BL, 80±9 letters at M6; CG: 78±8 letters at BL, 79±9 letters at M6). PR-CS showed a statistically significant increase (p<0.05) in the SG only (SG: CS-LogMar 128 at BL, 168 at M6; CG: CS-LogMar 147 at BL, 143 at M6).
Oral Lutein supplementation leads to a gradual, significant rise in MPD from BL up to M6 in the supplemented group (SG). At the same time, BCVA remains stable in both groups, supplemented and control group. EMPOLS shows a statistically significant rise in PR-CS only in the SG from BL till M6. Response to oral supplementation cannot be predicted directly from serum carotenoid levels. Further investigation, such as minute survey on supplementation cessation is currently in process and will round-up the understanding of Lutein supplementation.
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