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Comment & Response
December 2014

Comments on Infant Aphakia Treatment Study 4.5-Year Results—Reply

Scott R. Lambert, MD1; Michael J. Lynn, MS2; E. Eugenie Hartmann, PhD3; et al for the Infant Aphakia Treatment Study Group
Author Affiliations
  • 1Department of Ophthalmology, Emory Eye Center, Emory University, Atlanta, Georgia
  • 2Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia
  • 3Department of Visual Sciences, University of Alabama at Birmingham, Birmingham
JAMA Ophthalmol. 2014;132(12):1492-1493. doi:10.1001/jamaophthalmol.2014.3542

In Reply We appreciate the interest of Sueke and Chandna in the outcomes of the IATS.

The intention-to-treat strategy is used in randomized clinical trials to ensure that treatment groups remain similar.1 This strategy requires that patients are analyzed with the groups to which they were originally randomized even if they received a different treatment. One patient in our study was randomized to the IOL group but did not undergo IOL implantation, and 3 patients in the contact lens group received secondary IOLs. All of these patients were analyzed with the group to which they were originally randomized. Missing data can also be an issue. We were fortunate that this was not a major problem for the clinical outcomes assessed at follow-up examinations since only 1 patient was lost to follow-up, and for the primary outcome of optotype visual acuity at age 4.5 years, only 1 additional patient did not have data as a result of developmental delay. In contrast, patching adherence (which was not a clinical outcome) was assessed using recall telephone interviews every 3 months and a patching calendar completed by the child’s primary caregiver for 1 week each year. Because not all caregivers completed these calendars and some recall telephone interviews were missed, there were more missing data for patching adherence (missing data: year 1, 10%; years 2-5, <25%) than for the clinical outcomes.