Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2006 Jun;113(6):904-12.
doi: 10.1016/j.ophtha.2006.01.069.

A randomized trial to evaluate 2 hours of daily patching for strabismic and anisometropic amblyopia in children

David K Wallace  1 ; Pediatric Eye Disease Investigator Group; Allison R Edwards, Susan A Cotter, Roy W Beck, Robert W Arnold, William F Astle, Carmen N Barnhardt, Eileen E Birch, Sean P Donahue, Donald F Everett, Joost Felius, Jonathan M Holmes, Raymond T Kraker, Michele Melia, Michael X Repka, Nicholas A Sala, David I Silbert, Katherine K Weise
Affiliations
Randomized Controlled Trial

A randomized trial to evaluate 2 hours of daily patching for strabismic and anisometropic amblyopia in children

David K Wallace et al. Ophthalmology. 2006 Jun.

Abstract

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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flowchart showing study completion for patching and control groups – primary cohort. Both patching and control groups wore spectacles if required, and the patching group was prescribed 2 hours of patching per day plus one hour of near activities. Patients continued with these treatments until there was no improvement or the IOD<=0. In the patching group, 83 patients completed the outcome examination within the time window (4 - 6 weeks), 0 were early (3 to <4 weeks), and 2 were late (>6 to 10 weeks). In the control group, 79 patients completed the outcome examination within the time window (4 - 6 weeks), 2 were early (3 to <4 weeks), and 7 were late (>6 to 10 weeks). IOD – Interocular acuity difference
Figure 2
Figure 2
Cumulative distribution of best measured amblyopic eye visual acuity scores obtained at any study visit according to group assignment at randomization – primary cohort. A. Patients with moderate amblyopia at baseline (20/40-20/100). B. Patients with severe amblyopia at baseline (20/125-20/400).
Figure 2
Figure 2
Cumulative distribution of best measured amblyopic eye visual acuity scores obtained at any study visit according to group assignment at randomization – primary cohort. A. Patients with moderate amblyopia at baseline (20/40-20/100). B. Patients with severe amblyopia at baseline (20/125-20/400).
See this image and copyright information in PMC

Comment in

References

    1. Ederer F, Krueger DE. Report on the National Eye Institute's Visual Acuity Impairment Survey Pilot Study. Office of Biometry and Epidemiology, National Eye Institute, National Institutes of Health, Public Health Service, Department of Health and Human Services; Washington, DC: 1984. pp. 81–4.
    1. Attebo K, Mitchell P, Cumming R, et al. Prevalence and causes of amblyopia in an adult population. Ophthalmology. 1998;105:154–9. - PubMed
    1. Pediatric Eye Disease Investigator Group A randomized trial of patching regimens for treatment of moderate amblyopia in children. Arch Ophthalmol. 2003;121:603–11. - PubMed
    1. Pediatric Eye Disease Investigator Group A randomized trial of prescribed patching regimens for treatment of severe amblyopia in children. Ophthalmology. 2003;110:2075–87. - PubMed
    1. American Academy of Ophthalmology . Preferred practice pattern: amblyopia. American Academy of Ophthalmology; San Francisco: 2002. pp. 1–25.

Publication types

MeSH terms