A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E and beta carotene for age-related cataract and vision loss - AREDS Report No. 9

Kassoff, A Kassoff, J Buehler, J Eglow, M Kaufman, F Mehu, M Kieval, S Mairs, M Graig, B Quattrocchi, A Jones, D Locatelli, J Ruby, A Capone, A Garretson, B Hassan, T Trese, MT Williams, GA Regan, V Manatrey, P Streasick, P Szydlowski, L McIver, F Bridges, C Stanely, C Cumming, K Lewis, B Zajechowski, M Margherio, RR Cox, MS Werner, JC Falk, R Siedlak, P Neubert, C Klein, ML Stout, JT O'Malley, A Lauer, AK Robertson, JE Wilson, DJ Beardsley, C Anderson, H Wallace, P Smith, G Howard, S Dreyer, RF Ma, C Chenoweth, RG Zilis, JD Johnson, M Rice, P Daniel, H Crider, H Parker, S Sherman, K Martin, DF Aaberg, TM Sternberg, P Curtis, LT Ju, B Gilman, J Myles, B Strittman, S Gentry, C Yi, H Capone, A Lambert, M Meredith, T Aaberg, TM Saperstein, D Lim, JI Stribling, B Armiger, D Swords, R Orth, DH Flood, TP Civantos, J deBustros, S Packo, KH Merrill, PT Cohen, JA Figliulo, C Morrison, C Bryant, DA Doherty, D McVicker, M Drefcinski, T Seddon, JM Pinnolis, MK Davis, N Burton, I Taitsel, T Walsh, D Snow, KK Jones-Devonish, DA Crouse, VD Rosenberg, J Chew, EY Csaky, K Ferris, FL Shimel, KH Woods, MA Kuehl, EM Ciatto, PF Palmer, M Babilonia-Ayukawa, G Foster, GE Goodman, L Kim, YJ Kivitz, IJ Koutsandreas, D LaReau, A Mercer, RF Nashwinter, R McCarthy, SA Ayres, LM Lopez, P Randalls, A Friberg, TR Eller, AW Gorin, MB Nixon, S Mack, B Curtin, DY Ostroska, PP Fijewski, E Alexander, J Paine, MK Corbin, PS Warnicki, J Bressler, SB Bressler, NM Cassel, G Finkelstein, D Goldberg, M Haller, JA Ratner, L Schachat, AP Sherman, SH Sunness, JS Schenning, S Sackett, C Cain, D Emmert, D Herring, M McDonald, J Falk, R Wheeler, S Mcmillan, M George, T Elman, MJ Ballinger, R Betancourt, A Glasser, D Herr, M Hirsh, D Kilingsworth, D Kohlhepp, P Lammlein, J Raden, RZ Seff, R Shuman, M Starr, J Carrigan, A Sotirakos, P Cain, T Mathews, T Ringrose, C Chandra, SR Gottlieb, JL Ip, MS Klein, R Nork, TM Stevens, TS Blodi, BA Altaweel, M Klein, BEK Olson, M Soderling, B Blatz, M Perry-Raymond, JR Burke, K Knutson, G Peterson, J Krolnik, D Harrison, R Somers, G Myers, FL Wallow, I Olsen, TW Bresnik, G De Venecia, G Perkins, T Walker, W Miller, JL Neider, M Wabers, HD Weber, G Myers, HEL Davis, MD Klein, BEK Klein, R Hubbard, L Neider, M Wabers, HD Magli, YL Ansay, S Armstrong, J Lang, K Badal, D Geithman, PL Miner, KD Dohm, KL Esser, B Hurtenbach, C Craanen, S Webster, M Elledge, J Reed, S Benz, W Reimers, J Fisher, MR Gangnon, R King, W Gai, CY Baliker, J Carr, A Osterby, K Kastorff, L Robinson, N Onofrey, J Glander, KE Brickbauer, J Miller, D Sowell, A Gunter, E Bowman, B Lindblad, AS Milton, RC Clemons, TE Ederer, F Gensler, G Henning, A Entler, G McBee, W Roberts, K Stine, E Berlin, SH Tomlin, K Pallas, S Scholl, PR Mengers, SA Anand, R Ferris, FL Sperduto, RD Kurinij, N Chew, EY
A. Kassoff et al., A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E and beta carotene for age-related cataract and vision loss - AREDS Report No. 9, ARCH OPHTH, 119(10), 2001, pp. 1439-1452
Citations number
Categorie Soggetti
Optalmology,"da verificare
Journal title
ISSN journal
0003-9950 → ACNP
Year of publication
1439 - 1452
SICI code
Background: Experimental and observational data suggest that micronutrients with antioxidant capabilities may retard the development of age-related ca taract. Objective: To evaluate the effect of a high-dose antioxidant formulation on the development and progression of age-related lens opacities and visual a cuity loss. Design: The 11-center Age-Related Eye Disease Study (AREDS) was a double-ma sked clinical trial. Participants were randomly assigned to receive daily o ral tablets containing either antioxidants (vitamin C, 500 mg; vitamin E, 4 00 IU; and beta carotene, 15 mg) or no antioxidants. Participants with more than a few small drusen were also randomly assigned to receive tablets wit h or without zinc (80 mg of zinc as zinc oxide) and copper (2 mg of copper as cupric oxide) as part of the age-related macular degeneration trial. Bas eline and annual (starting at year 2) lens photographs were graded at a rea ding center for the severity of lens opacities using the AREDS cataract gra ding scale. Main Outcome Measures: Primary outcomes were (1) an increase from baseline in nuclear, cortical, or posterior subcapsular opacity grades or cataract s urgery, and (2) at least moderate visual acuity loss from baseline (greater than or equal to 15 letters). Primary analyses used repeated-measures logi stic regression with a statistical significance level of P = .01. Serum lev el measurements, medical histories, and mortality rates were used for safet y monitoring. Results: Of 4757 participants enrolled, 4629 who were aged from 55 to 80 ye ars had at least 1 natural lens present and were followed up for an average of 6.3 years. No statistically significant effect of the antioxidant formu lation was seen on the development or progression of age-related lens opaci ties (odds ratio = 0.97, P = .55). There was also no statistically signific ant effect of treatment in reducing the risk of progression for any of the 3 lens opacity types or for cataract surgery. For the 1117 participants wit h no age-related macular degeneration at baseline, no statistically signifi cant difference was noted between treatment groups for at least moderate vi sual acuity loss. No statistically significant serious adverse effect was a ssociated with treatment. Conclusion: Use of a high-dose formulation of vitamin C, vitamin E, and bet a carotene in a relatively well-nourished older adult cohort had no apparen t effect on the 7-year risk of development or progression of age-related le ns opacities or visual acuity loss.