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Participants and Methods in AREDS Report No. 8

W. Rex Hawkins, MD
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Copyright 2008 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

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Arch Ophthalmol. 2008;126(1):146-147. doi:10.1001/archophthalmol.2007.13
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Subsequent to publication of Age-Related Eye Disease Study (AREDS) report No. 8,1 an increasing number of articles have linked age-related macular degeneration (AMD) and cataract surgery.2 5 The studies have relevance to AREDS report No. 8 for which cataract surgery was not considered a reason for participant exclusion. The AREDS Coordinating Center acknowledged, in correspondence with me (Roy C. Milton, PhD, written communication, October 19, 2006), that 161 participants were unilaterally pseudophakic and that another 507 required cataract surgery during the study. Such information was not included in the published article.

The recent articles suggest that cataract surgery should be an indication for exclusion in AMD therapy trials such as that described in AREDS report No. 8. I question whether the AREDS investigators now wonder whether the selection process was flawed with respect to the inclusion of eyes that underwent cataract surgery and whether they have considered reevaluation of the data following exclusion of such participants.

They might also consider excluding those participants who developed neovascular AMD during the initial months of the trial. The study described in AREDS report No. 8 was conducted without the benefit of fluorescein angiographic detection of the primary outcome, the progression to neovascular AMD. Some of the enrollees might have had occult neovascular AMD at the time of enrollment, which leads one to ask, how many of the participants developed stereoscopic fundus photography indication (the examination technique used by the authors of AREDS report No. 8) of neovascular AMD within, say, the first 8 months? Should not, for conservative analysis, those participants have also been eliminated from the clinical significance calculations?

AUTHOR INFORMATION

Correspondence: Dr Hawkins, Retina-Vitreous Associates, 1200 Binz, Ste 400, Houston, TX 77004 (office@rvahouston.com).

Financial Disclosure: None reported.

REFERENCES

Age-Related Eye Disease Study Research Group,  A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report No. 8. Arch Ophthalmol 2001;119 (10) 1417- 1436
PubMed
Klein  R, Klein  BE, Wong  TY, Tomany  SC, Cruickshanks  KJ. The association of cataract and cataract surgery with long-term incidence of age-related maculopathy: the Beaver Dam Eye Study. Arch Ophthalmol 2002;120 (11) 1551- 1558
PubMed
Wang  JJ, Klein  R, Smith  W, Klein  BE, Tomany  S, Mitchell  P. Cataract surgery and the 5-year incidence of late-stage age-related maculopathy: pooled findings from the Beaver Dam and Blue Mountains eye studies. Ophthalmology 2003;110 (10) 1960- 1967
PubMed
Krishnaiah  S, Das  T, Nirmalan  PK.  et al.  Risk factors for age-related macular degeneration: findings from the Andhra Pradesh eye disease study in South India. Invest Ophthalmol Vis Sci 2005;46 (12) 4442- 4449
PubMed
Cugati  S, Mitchell  P, Rochtchina  E, Tan  AG, Smith  W, Wang  JJ. Cataract surgery and the 10-year incidence of age-related maculopathy: the Blue Mountains Eye Study. Ophthalmology 2006;113 (11) 2020- 2025
PubMed

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Age-Related Eye Disease Study Research Group,  A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report No. 8. Arch Ophthalmol 2001;119 (10) 1417- 1436
PubMed
Klein  R, Klein  BE, Wong  TY, Tomany  SC, Cruickshanks  KJ. The association of cataract and cataract surgery with long-term incidence of age-related maculopathy: the Beaver Dam Eye Study. Arch Ophthalmol 2002;120 (11) 1551- 1558
PubMed
Wang  JJ, Klein  R, Smith  W, Klein  BE, Tomany  S, Mitchell  P. Cataract surgery and the 5-year incidence of late-stage age-related maculopathy: pooled findings from the Beaver Dam and Blue Mountains eye studies. Ophthalmology 2003;110 (10) 1960- 1967
PubMed
Krishnaiah  S, Das  T, Nirmalan  PK.  et al.  Risk factors for age-related macular degeneration: findings from the Andhra Pradesh eye disease study in South India. Invest Ophthalmol Vis Sci 2005;46 (12) 4442- 4449
PubMed
Cugati  S, Mitchell  P, Rochtchina  E, Tan  AG, Smith  W, Wang  JJ. Cataract surgery and the 10-year incidence of age-related maculopathy: the Blue Mountains Eye Study. Ophthalmology 2006;113 (11) 2020- 2025
PubMed

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