Elsevier

Ophthalmology

Volume 113, Issue 6, June 2006, Pages 904-912
Ophthalmology

Original Article
A Randomized Trial to Evaluate 2 Hours of Daily Patching for Strabismic and Anisometropic Amblyopia in Children

https://doi.org/10.1016/j.ophtha.2006.01.069Get rights and content

Objective

To compare 2 hours of daily patching (combined with 1 hour of concurrent near visual activities) with a control group of spectacle wear alone (if needed) for treatment of moderate to severe amblyopia in children 3 to 7 years old.

Design

Prospective randomized multicenter clinical trial (46 sites).

Participants

One hundred eighty children 3 to 7 years old with best-corrected amblyopic-eye visual acuity (VA) of 20/40 to 20/400 associated with strabismus, anisometropia, or both who had worn optimal refractive correction (if needed) for at least 16 weeks or for 2 consecutive visits without improvement.

Intervention

Randomization either to 2 hours of daily patching with 1 hour of near visual activities or to spectacles alone (if needed). Patients were continued on the randomized treatment (or no treatment) until no further improvement was noted.

Main Outcome Measure

Best-corrected VA in the amblyopic eye after 5 weeks.

Results

Improvement in VA of the amblyopic eye from baseline to 5 weeks averaged 1.1 lines in the patching group and 0.5 lines in the control group (P = 0.006), and improvement from baseline to best measured VA at any visit averaged 2.2 lines in the patching group and 1.3 lines in the control group (P<0.001).

Conclusion

After a period of treatment with spectacles, 2 hours of daily patching combined with 1 hour of near visual activities modestly improves moderate to severe amblyopia in children 3 to 7 years old.

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,

References (21)

  • K. Attebo et al.

    Prevalence and causes of amblyopia in an adult population

    Ophthalmology

    (1998)
  • P.S. Moke et al.

    Computerized method of visual acuity testingadaptation of the Amblyopia Treatment Study visual acuity testing protocol

    Am J Ophthamol

    (2001)
  • F. Ederer et al.
  • A randomized trial of patching regimens for treatment of moderate amblyopia in children

    Arch Ophthalmol

    (2003)
  • A randomized trial of prescribed patching regimens for treatment of severe amblyopia in children

    Ophthalmology

    (2003)
  • American Academy of Ophthalmology Pediatric Ophthalmology Panel.. Preferred practice pattern. Amblyopia. San Francisco:...
  • American Optometric Association Consensus Panel on Care of the Patient with Amblyopia. Optometric clinical practice...
  • A randomized trial of atropine vs. patching for treatment of moderate amblyopia in children

    Arch Ophthalmol

    (2002)
  • S.K. Snowdon et al.

    Preschool vision screening

    Health Technol Assess

    (1997)
  • P. Lempert

    The effectiveness of patching for amblyopia should be tested with untreated control subjects [letter]

    Arch Ophthalmol

    (2004)
There are more references available in the full text version of this article.

Cited by (174)

  • Amblyopia and the whole child

    2023, Progress in Retinal and Eye Research
View all citing articles on Scopus

Manuscript no. 2005-1118.

Supported by the National Eye Institute, Bethesda, Maryland (cooperative agreement no.: EY11751).

See “Acknowledgments” for the writing committee and where to find a list of the members of the Group participating in the trial.

View full text