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Atropine Regimens for Amblyopia: Author reply
Letters to the Editor Amblyopia studies should not be exempted from these basic requirements. It would be helpful for future studies of amblyopia treatment to comply with accepted standards of clinical research. PHILIP LEMPERT, MD Ithaca, New York References 1. Pediatric Eye Disease Investigator Group. A randomized trial of atropine regimens for treatment of moderate amblyopia in children. Ophthalmology 2004;111:2076 – 85. 2. Pediatric Eye Disease Investigator Group. A randomized trial of atropine vs. patching for treatment of moderate amblyopia in children. Arch Ophthalmol 2002;120:268 –78. 3. Repka MX, Beck RW, Holmes JM, et al, Pediatric Eye Disease Investigator Group. A randomized trial of patching regimens for treatment of moderate amblyopia in children. Arch Ophthalmol 2003;121:603–11. 4. Miller FG, Emanuel EJ, Rosenstein DL, Straus SE. Ethical issues concerning research in complementary and alternative medicine. JAMA 2004;291:599 – 604. 5. Beck RW. Reporting the results of randomized clinical trials: a priority of Archives of Ophthalmology. Arch Ophthalmol 2004;122:1038 –9.
Reference 1. Beck RW. Reporting the results of randomized clinical trials: a priority of Archives of Ophthalmology. Arch Ophthalmol 2004;122:1038 –9.
Sub-Tenon’s Triamcinolone Dear Editor: It was with great interest that I noted that Paganelli et al described in a recent report comparable efficacies in a single intraoperative posterior sub–Tenon’s capsule steroid injection and topical steroids in the treatment of post– cataract surgery inflammation.1 Although not noted in their article, I first described a similar technique more than 10 years ago as a means of preventing or controlling postoperative inflammation after vitreoretinal or anterior segment surgery.2 As Paganelli et al point out, this technique is technically simple, with virtually no risk of complications. Anecortave acetate, an investigational treatment of age-related macular degeneration, uses a very similar drug delivery technique, also with an excellent safety profile.3 Hopefully, the authors will continue their important studies of this intraoperative drug delivery technique. BRIAN C. JOONDEPH, MD Denver, Colorado
Author reply Dear Editor: We disagree with Dr Lempert’s comment with regard to our methodology. The randomized trials conducted by the Pediatric Eye Disease Investigator Group follow well-accepted clinical trial methodology. In a randomized clinical trial, a control group may be assigned standard care rather than a placebo. In this specific amblyopia treatment trial, the daily atropine group was the control group, which was compared with the weekendonly atropine group. Before initiation of a Pediatric Eye Disease Investigator Group study, every protocol is reviewed and approved by an independent National Eye Institute–appointed panel of experts that includes statisticians and clinical trialists. In addition, Dr Lempert inaccurately cites the Archives of Ophthalmology editorial written by one of us (RWB).1 The importance of randomization in clinical trials is emphasized, but the editorial does not address the issue of placebo controls and when they are needed. MICHAEL X. REPKA, MD SUSAN A. COTTER, OD ROY W. BECK, MD, PHD RAYMOND T. KRAKER, MSPH EILEEN E. BIRCH, PHD DONALD F. EVERETT, MA RICHARD W. HERTLE, MD JONATHAN M. HOLMES, BM, BCH GRAHAM E. QUINN, MD, MSCE NICHOLAS A. SALA, DO MITCHELL M. SCHEIMAN, OD DAVID R. STAGER, SR, MD DAVID K. WALLACE, MD On behalf of the Pediatric Eye Disease Investigator Group
References 1. Paganelli F, Cardillo JA, Melo LA Jr, et al, Brazilian Ocular Pharmacology and Pharmaceutical Technology Research Group. A single intraoperative sub–Tenon’s capsule triamcinolone acetonide injection for the treatment of post– cataract surgery inflammation. Ophthalmology 2004;111:2102– 8. 2. Joondeph BC. A new technique for the administration of intraoperative periocular corticosteroids. Am J Ophthalmol 1991;111:647– 8. 3. D’Amico DJ, Goldberg MF, Hudson H, et al. Anecortave acetate as monotherapy for treatment of subfoveal neovascularization in age-related macular degeneration: twelve-month clinical outcomes. Ophthalmology 2003;110:2372– 83.
Author reply Dear Editor: With all due respect for the work of Dr Joondeph described in his article on a new technique for the administration of intraoperative periocular corticosteroid, we describe a somewhat different approach. Briefly, in our study the bulbar conjunctiva was grasped about 10 mm away from the limbus using a forceps at the site of intended entry into the inferotemporal quadrant. At this point, entry was made into the episcleral space using the trocar of a 23-gauge IV cannula made of polytetrafluorethylene. The trocar and cannula were advanced together for about 3 mm within the episcleral space under direct visualization. Subsequently, the trocar was withdrawn entirely, and the cannula alone was guided further posteriorly for about 10 mm. Dr Joondeph describes in his article a scissors incision through conjunctiva and Tenon’s capsule to bare sclera, followed by insertion of a blunt 19-gauge cannula. In fact, we believe that both posterior juxtascleral procedures can be safely used for administering medication onto the outer surface of
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Reference 1. Beck RW. Reporting the results of randomized clinical trials: a priority of Archives of Ophthalmology. Arch Ophthalmol 2004;122:1038 –9.
Sub-Tenon’s Triamcinolone Dear Editor: It was with great interest that I noted that Paganelli et al described in a recent report comparable efficacies in a single intraoperative posterior sub–Tenon’s capsule steroid injection and topical steroids in the treatment of post– cataract surgery inflammation.1 Although not noted in their article, I first described a similar technique more than 10 years ago as a means of preventing or controlling postoperative inflammation after vitreoretinal or anterior segment surgery.2 As Paganelli et al point out, this technique is technically simple, with virtually no risk of complications. Anecortave acetate, an investigational treatment of age-related macular degeneration, uses a very similar drug delivery technique, also with an excellent safety profile.3 Hopefully, the authors will continue their important studies of this intraoperative drug delivery technique. BRIAN C. JOONDEPH, MD Denver, Colorado
Author reply Dear Editor: We disagree with Dr Lempert’s comment with regard to our methodology. The randomized trials conducted by the Pediatric Eye Disease Investigator Group follow well-accepted clinical trial methodology. In a randomized clinical trial, a control group may be assigned standard care rather than a placebo. In this specific amblyopia treatment trial, the daily atropine group was the control group, which was compared with the weekendonly atropine group. Before initiation of a Pediatric Eye Disease Investigator Group study, every protocol is reviewed and approved by an independent National Eye Institute–appointed panel of experts that includes statisticians and clinical trialists. In addition, Dr Lempert inaccurately cites the Archives of Ophthalmology editorial written by one of us (RWB).1 The importance of randomization in clinical trials is emphasized, but the editorial does not address the issue of placebo controls and when they are needed. MICHAEL X. REPKA, MD SUSAN A. COTTER, OD ROY W. BECK, MD, PHD RAYMOND T. KRAKER, MSPH EILEEN E. BIRCH, PHD DONALD F. EVERETT, MA RICHARD W. HERTLE, MD JONATHAN M. HOLMES, BM, BCH GRAHAM E. QUINN, MD, MSCE NICHOLAS A. SALA, DO MITCHELL M. SCHEIMAN, OD DAVID R. STAGER, SR, MD DAVID K. WALLACE, MD On behalf of the Pediatric Eye Disease Investigator Group
References 1. Paganelli F, Cardillo JA, Melo LA Jr, et al, Brazilian Ocular Pharmacology and Pharmaceutical Technology Research Group. A single intraoperative sub–Tenon’s capsule triamcinolone acetonide injection for the treatment of post– cataract surgery inflammation. Ophthalmology 2004;111:2102– 8. 2. Joondeph BC. A new technique for the administration of intraoperative periocular corticosteroids. Am J Ophthalmol 1991;111:647– 8. 3. D’Amico DJ, Goldberg MF, Hudson H, et al. Anecortave acetate as monotherapy for treatment of subfoveal neovascularization in age-related macular degeneration: twelve-month clinical outcomes. Ophthalmology 2003;110:2372– 83.
Author reply Dear Editor: With all due respect for the work of Dr Joondeph described in his article on a new technique for the administration of intraoperative periocular corticosteroid, we describe a somewhat different approach. Briefly, in our study the bulbar conjunctiva was grasped about 10 mm away from the limbus using a forceps at the site of intended entry into the inferotemporal quadrant. At this point, entry was made into the episcleral space using the trocar of a 23-gauge IV cannula made of polytetrafluorethylene. The trocar and cannula were advanced together for about 3 mm within the episcleral space under direct visualization. Subsequently, the trocar was withdrawn entirely, and the cannula alone was guided further posteriorly for about 10 mm. Dr Joondeph describes in his article a scissors incision through conjunctiva and Tenon’s capsule to bare sclera, followed by insertion of a blunt 19-gauge cannula. In fact, we believe that both posterior juxtascleral procedures can be safely used for administering medication onto the outer surface of
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