An Evaluation of Treatment of Amblyopia in Children 7 To <18 Years Old
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional
Phase: Phase 3

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 description: 
      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 of 13) in addition to spectacles (Active Treatment
      Group). It will enroll a minimum of 90 patients in each of the age groups of 7 to <9, 9 to
      <11, 11 to <13, and 13 to <18 years old. Patients have follow up visits every 6 weeks (up to
      a maximum of 24 weeks) until they are classified as either responders or nonresponders based
      on amblyopic eye visual acuity. At the end of the randomized trial:

        -  Patients who did not respond to treatment end follow up.

        -  Patients who responded to treatment continue in their respective treatment groups until
           visual acuity stops improving.

      Once there is no further improvement in visual acuity:

        -  Patients in the Control Group end follow up

        -  Patients in the Active Treatment Group discontinue active treatment and have follow up
           visits at 13 weeks, 26 weeks, and 52 weeks timed from treatment discontinuation.
    

Intervention name(s): Eye patch; spectacles; atropine
Intervention type(s): Device; Device; Drug
Intervention MeSH terms: Atropine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amblyopia; Patching; Spectacles