Clinical Trial: Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds

Brief Summary:

The purpose of this study is:

  • To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to <13 year olds.
  • To determine the maximum improvement in vision of the amblyopic eye with each treatment.
  • To determine whether amblyopia is associated with structural abnormalities of optic nerve fiber layer.

Detailed Summary:

Although there is consensus that amblyopia can be treated effectively in young children, many eye care practitioners believe that treatment beyond a certain age is ineffective. Some clinicians have believed that a treatment response is unlikely after the age of 6 or 7 years, while others have considered age 9 or 10 years to be the upper age limit for successful treatment. The American Academy of Ophthalmology Preferred Practice Pattern for amblyopia recommends treatment up to age 10 years. The opinion that amblyopia treatment is ineffective in older children may have arisen because the age of 6 to 7 years is thought to be the end of the "critical period" for visual development in humans. This belief, however, was not based on adequate prospectively-collected data.

To address this issue of the response of amblyopia to treatment in children 7 years and older, the Pediatric Eye Disease Investigator Group (PEDIG) conducted a randomized trial of 507 patients (aged 7 to <18 years) with amblyopic eye visual acuity ranging from 20/40 to 20/400. Patients were provided with optimal optical correction and then randomized to a Treatment Group (2 to 6 hours per day of prescribed patching of the sound eye combined with near visual activities for all patients plus atropine one drop per day in the sound eye for 7 to <13 year olds) or an Optical Correction Group (optical correction alone). Patients whose amblyopic eye acuity improved 10 or more letters (2 lines) by 24 weeks were considered responders. In the 7 to <13 year olds (N=404), 53% of the Treatment Group were responders compared with 25% of the Optical Correction Group (P<0.001). In the 13 to <18 year olds (N=103), the responder rates were 25% and 23% respectively overall (adjusted P=0.22), but 47% and 20% respectively among patients not previously treated with patching and/or atropine for amblyopia (adjus
Sponsor: Jaeb Center for Health Research

Current Primary Outcome:

  • Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks [ Time Frame: 17 weeks ]
    Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
  • Mean Visual Acuity in the Amblyopic Eye at 17 Weeks [ Time Frame: 17 weeks ]
    Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
  • Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks [ Time Frame: Baseline to 17 weeks ]

    Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.

    A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.

  • Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks [ Time Frame: Baseline to 17 weeks ]

    Visual acuity was measured at baseline and 17 we

    Original Primary Outcome: Visual acuity

    Current Secondary Outcome:

    • Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia [ Time Frame: 17 or 19 weeks ]
      The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
    • Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only [ Time Frame: 17 or 19 weeks ]
      The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
    • Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism [ Time Frame: 17 or 19 weeks ]
      The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
    • Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia [ Time Frame: 17 or 19 weeks ]
      Stereoacuity is scored as seconds of arc with values of: <800, 800, 400, 200, 100, 60, 40. The lower the arc second value, the better the score (i.e. 40 arc sec is best stereoacuity; <800 is the worst). A change score was defined as the difference between baseline and outcome in score level (i.e. moving from 800 at baseline to 400 at outcome is one level change, moving from 800 to 200 is two levels, etc.) change in levels was categorized as "within one level" meaning change was -1, 0, or +1.
    • Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only) [ Time Frame: 17 weeks ]
      Questionnaire scores on the Social Stigma subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.
    • Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only) [ Time Frame: 17 weeks ]
      Questionnaire scores on the compliance subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.
    • Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only) [ Time Frame: 17 weeks ]
      Questionnaire scores on the adverse events subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.
    • Distribution of Visual Acuity in the Fellow Eye at 17 Weeks [ Time Frame: 17 weeks ]
      Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
    • Mean Visual Acuity in the Fellow Eye at 17 Weeks [ Time Frame: 17 weeks ]
      Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
    • Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks [ Time Frame: Baseline to 17 weeks ]

      Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 wee

      Original Secondary Outcome:

      Information By: Jaeb Center for Health Research

      Dates:
      Date Received: April 14, 2006
      Date Started: August 2005
      Date Completion:
      Last Updated: May 19, 2016
      Last Verified: May 2016