Pediatric Eye Disease Investigator Group (PEDIG)

Protocol: ATS02C - An Observational Study on Recurrence of Amblyopia After Discontinuation of Treatment
Status: Closed
Start Date: 05/12/2001
End Date: 11/30/2003
Clinical Trial ID: N/A
Public Dataset:  


An Observational Study on Recurrence of Amblyopia After Discontinuation of Treatment

Protocol

Background:
Although amblyopia can be successfully treated with patching or atropine, there have been few prospective studies of amblyopia recurrence once treatment is stopped.

Methods:
We enrolled 156 children with successfully treated anisometropic or strabismic amblyopia (145 completed follow up), less than 8 years of age, who received continuous amblyopia treatment for the previous 3 months (prescribed at least 2 hours of daily patching or prescribed at least one drop of atropine per week) and who had improved at least 3 logMAR levels during the period of continuous treatment. Patients were followed off treatment for 52 weeks to assess recurrence of amblyopia, defined as a 2 or more logMAR level reduction of visual acuity from enrollment, confirmed by a second exam. Recurrence was also considered to have occurred if treatment was restarted due to a non-replicated 2 or more logMAR level reduction of visual acuity.

Results:
Recurrence occurred in 35 (24%) of 145 cases (95% confidence interval 17% to 32%) and was similar in patients who stopped patching (25%) and in patients who stopped atropine (21%). In patients treated with moderately intense patching (6 to 8 hours per day), recurrence was more common (11 of 26, 42%) when treatment was not reduced prior to cessation than when treatment was reduced to 2 hours per day prior to cessation (3 of 22, 14%, odds ratio 4.4, 95% confidence interval 1.0 to 18.7).

Conclusions:
Approximately one fourth of successfully-treated amblyopic children experience a recurrence within the first year off treatment. For patients treated with 6 or more hours of daily patching, our data suggest that the risk of recurrence is greater when patching is stopped abruptly rather than when it is reduced to 2 hours per day prior to cessation. A randomized clinical trial of no weaning versus weaning in successfully-treated amblyopia is warranted to confirm these observational findings.

Published:

  1. Pediatric Eye Disease Investigator Group. Risk of amblyopia recurrence after cessation of treatment. J AAPOS 2004;8:420-8.
  2. Holmes JM, Melia M, Bradfield YS, et al. Factors associated with recurrence of amblyopia on cessation of patching. Ophthalmology 2007;114:1427-32.

 



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