Atropine Regimens for Amblyopia: Author reply

Abstract

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 weekend-only 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).1Beck R.W. Reporting the results of randomized clinical trials a priority of Archives of Ophthalmology.Arch Ophthalmol. 2004; 122: 1038-1039Crossref PubMed Scopus (1) Google Scholar 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. 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 weekend-only 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).1Beck R.W. Reporting the results of randomized clinical trials a priority of Archives of Ophthalmology.Arch Ophthalmol. 2004; 122: 1038-1039Crossref PubMed Scopus (1) Google Scholar 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. Atropine Regimens for AmblyopiaOphthalmologyVol. 112Issue 8PreviewA recent Pediatric Eye Disease Investigator Group article demonstrates that treatment of amblyopia with weekend atropine provides the same level of improvement as daily atropine.1 It was previously shown that atropine occlusion is equivalent to patching2 and that 6 hours of patching is equivalent to 2 hours of daily patching.3 Full-Text PDF