To the Editor: The review of age-related macular degenerationby Jager et al. (June 12 issue)1 does not refer to an editorialaccompanying the report of the Age-Related Eye Disease Study(AREDS) in the Archives of Ophthalmology in 2001 and two subsequentletters,2,3,4 all of which criticized the study analysis forsetting aside a negative result in which dietary supplementationwith high doses of vitamins and minerals was ineffective andinstead reporting on a subgroup in which the result was positive.The investigators argued that the excluded patients had toofew end points to be eligible for treatment. However, the groupof patients who received the supplement had greater diseaseprogression and provided valuable data regarding early intervention.
Discarding prespecified negative analyses and reporting on positivesubgroup analyses has been repeatedly discouraged.5 The omissionof the above information perpetuates the myth that the supplementused in the AREDS was effective, at the price of a treatmentthat has no benefit and carries undetermined risks.
Daniel Seigel, Sc.D. 1135 Pleasant Pt. Rd. Cushing, ME 04563 dseigel{at}midcoast.com
References
Jager RD, Mieler WF, Miller JW. Age-related macular degeneration. N Engl J Med 2008;358:2606-2617. [Free Full Text]
Jampol LM. Antioxidants, zinc, and age-related macular degeneration: results and recommendations. Arch Ophthalmol 2001;119:1533-1534. [Free Full Text]
Seigel D. AREDS investigators distort findings. Arch Ophthalmol 2002;120:100-101. [Free Full Text]
Ambati J, Ambati BK. Age-Related Eye Disease Study caveats. Arch Ophthalmol 2002;120:997-997. [Free Full Text]
Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine -- reporting of subgroup analyses in clinical trials. N Engl J Med 2007;357:2189-2194. [Free Full Text]
To the Editor: The review of age-related macular degenerationcontains one problem: the inaccurate use of the term "legalblindness." The authors imply that decreased vision in one eyemay make that eye legally blind. This is incorrect: one eyecannot be legally blind, but a person may be legally blind.In the United States, "Statutory blindness is defined in thelaw as central visual acuity of 20/200 or less in the bettereye with the use of [a] correcting lens."1 Additional qualificationsapply in the case of restricted visual fields.1,2 The properdefinition is of financial and sociological importance to patients.
Robert J. Herm, M.D. Robert E. Lee Ln. Bluffton, SC 29909 b2herm{at}hargray.com
References
Social Security Administration, 20 C.F.R. 404.1581 (1983).
The authors reply: With regard to Seigel's comments, we believethat the authors of the report of the AREDS1 responded adequatelyto any concerns raised in correspondence after publication oftheir article. The authors of that report recognized the potentialperils of subgroup analyses of nonprespecified groups and werenot issuing a blanket recommendation for megadose supplements.2,3Our review also acknowledges that the supplementation used inthe AREDS may not be appropriate for all patients. Instead,we believe that the decision to initiate this supplementationshould be based on a coordinated effort among the vitreoretinalspecialist, the primary care physician, and the patient.
We disagree with the assertion that this supplementation hasno benefit. In our opinion, it has clearly been shown to decreasethe rate of visual loss in selected patients with age-relatedmacular degeneration. Recommendations from the report of theAREDS are part of the evidence-based preferred practice patternsof the American Academy of Ophthalmology for the managementof age-related macular degeneration, and they were rated ashaving the highest strength of evidence (based on study design)as well as being most important for the care process.4
Herm raises an important point. Indeed, one can easily inferfrom the article that an eye can become legally blind: "Althoughneovascular age-related macular degeneration represents only10 to 15% of the overall prevalence of age-related macular degeneration,it is responsible for more than 80% of cases of severe visualloss or legal blindness (i.e., visual acuity of 20/200 or worse)resulting from age-related macular degeneration." The words"or legal blindness" should have been omitted from the article.Herm is correct, and his point is well taken.
Rama D. Jager, M.D. University of Chicago Chicago, IL 60637 rjager{at}uretina.com
William F. Mieler, M.D. University of Illinois Chicago, IL 60612
Joan W. Miller, M.D. Harvard University Boston, MA 02115
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;119:1417-1436. [Free Full Text]
Seigel D. AREDS investigators distort findings. Arch Ophthalmol 2002;120:100-101. [Free Full Text]
Ambati J, Ambati BK. Age-Related Eye Disease Study caveats. Arch Ophthalmol 2002;120:997-997. [Free Full Text]
Correction
to
Jager et al., 
404.1581 (1983).
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