Clinical Trial: An Evaluation of Treatment of Amblyopia in Children 7 To <18 Years Old
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Evaluation of Treatment of Amblyopia in 7 To <18 Year Olds
Brief Summary:
The goals of this study are:
- To determine the response rate of treatment of amblyopia in 7 to <18 year olds.
- To determine the frequency of recurrence of amblyopia in 7 to <18 year olds after discontinuation of amblyopia treatment.
Detailed Summary:
Most eye care practitioners believe that there is an age beyond which attempting to treat amblyopia is futile. It is generally held that the response to treatment is best when it is instituted at an early age and is poor when attempted after eight years of age. There has not been a prospective clinical trial conducted with appropriate rigor that has evaluated the effect of treatment of amblyopia in children aged 7 years or older. Although available data on the efficacy of amblyopia treatment of older children are limited, there is reason to believe from clinical observations and published case series that treatment could have benefit. In a pilot study of patients 10 to <18 years old with amblyopia, we found that 37 percent of 52 patients showed improvement in the amblyopic eye acuity of 2 or more lines after treatment with part-time patching. However, without a concurrent randomized control group, the results are not conclusive. Although the literature and our pilot study provide support that amblyopia can be improved with treatment, neither the response rate to treatment nor the recidivism rate after cessation of treatment can be well defined. Despite the evidence that amblyopia therapy can be effective in older children, many clinicians do not attempt treatment under the assumption that it will be unsuccessful. Therefore, a clinical trial is needed to provide the requisite data to establish clinical practice guidelines for the treatment of amblyopia in older children. In addition to its importance for patient management, the trial's results will meet the demand for cost effectiveness by health maintenance organizations, large employers, and insurers.
The study is a randomized trial comparing patients treated with spectacles only (Control Group) to patients undergoing active treatment (patching, near activities while patching, and atropine for children under the age o
Sponsor: Jaeb Center for Health Research
Current Primary Outcome: Visual acuity improvement
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Jaeb Center for Health Research
Dates:
Date Received: October 21, 2004
Date Started: October 2002
Date Completion:
Last Updated: March 23, 2010
Last Verified: May 2007
