Original ArticleA Randomized Trial to Evaluate 2 Hours of Daily Patching for Strabismic and Anisometropic Amblyopia in Children
Section snippets
Patients and Methods
The study, supported through a cooperative agreement with the National Eye Institute of the National Institutes of Health, was conducted by the Pediatric Eye Disease Investigator Group at 46 clinical sites. The protocol and Health Insurance Portability and Accountability Act–compliant informed consent forms were approved by institutional review boards, and the parent or guardian (referred to subsequently as parent) of each study patient gave written informed consent. Study oversight was
Primary Cohort
Between March 2004 and June 2005, 180 patients with amblyopic-eye acuity of 20/40 to 20/400 (mean = 0.56 logMAR, approximately 20/80) and an interocular acuity difference of ≥3 lines (mean = 5.3 lines) were assigned randomly to the patching group (n = 87) or to the control group (n = 93). The number of patients enrolled per site at the 46 sites ranged from 1 to 24 (median = 2.5). The average age of the patients at randomization was 5.4 years. The baseline characteristics of the 2 groups were
Discussion
We evaluated the effectiveness of 2 hours of daily patching combined with 1 hour of near visual activity versus a control group (wearing optical correction if needed) in the treatment of moderate and severe amblyopia in children 3 to 7 years old. All patients who required refractive error correction entered the trial only after having worn optimal spectacles for at least 16 weeks before enrollment or after having demonstrated no improvement in VA from a study visit 5 weeks previously. The
Acknowledgments
Writing Committee: Lead authors: David K. Wallace, MD, Allison R. Edwards, MS, Susan A. Cotter, OD, Roy W. Beck, MD, PhD. Additional writing committee members (alphabetical): Robert W. Arnold, MD, William F. Astle, MD, Carmen N. Barnhardt, OD, Eileen E. Birch, PhD, Sean P. Donahue, MD, PhD, Donald F. Everett, MA, Joost Felius, PhD, Jonathan M. Holmes, BM, BCh, Raymond T. Kraker, MSPH, B. Michele Melia, ScM, Michael X. Repka, MD, Nicholas A. Sala, DO, David I. Silbert, MD, Katherine K. Weise,
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Manuscript no. 2005-1118.
Supported by the National Eye Institute, Bethesda, Maryland (cooperative agreement no.: EY11751).
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See “Acknowledgments” for the writing committee and where to find a list of the members of the Group participating in the trial.