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Combined Patching-Atropine for Residual Amblyopia (ATS11)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00506675
Recruitment Status : Terminated (Poor enrollment and infeasibility of ever reaching the necessary sample size)
First Posted : July 25, 2007
Results First Posted : March 23, 2011
Last Update Posted : July 13, 2016
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Ray Kraker, Jaeb Center for Health Research

Tracking Information
First Submitted Date  ICMJE July 20, 2007
First Posted Date  ICMJE July 25, 2007
Results First Submitted Date  ICMJE September 14, 2010
Results First Posted Date  ICMJE March 23, 2011
Last Update Posted Date July 13, 2016
Study Start Date  ICMJE October 2007
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2011)
  • Distribution of Amblyopic Eye Visual Acuity at 10 Weeks [ Time Frame: 10 Weeks ]
    Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).
  • Mean (SD) Distribution of Visual Acuity at 10 Weeks [ Time Frame: 10 Weeks ]
    Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).
  • Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks [ Time Frame: baseline to 10 Weeks ]
    Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.
  • Mean (SD) Change in Visual Acuity in the Amblyopic Eye at the 10 Week Primary Outcome Exam [ Time Frame: baseline to 10 Weeks ]
    Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2007)
Amblyopic eye visual acuity [ Time Frame: 10 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Patching-Atropine for Residual Amblyopia
Official Title  ICMJE A Randomized Trial to Evaluate Combined Patching-Atropine for Residual Amblyopia
Brief Summary

This study is designed to evaluate the effectiveness of treatment of residual amblyopia in children ages 3 to < 10 years with visual acuity of 20/32 to 20/63 in the amblyopic eye. The study is a randomized clinical trial comparing intensive treatment (42 hours per week of patching plus daily atropine) with a control group that will have rapid weaning of existing treatment followed by spectacle correction only (if needed). The primary objective is to determine if this intensive treatment will improve visual acuity in patients with residual amblyopia.

The primary outcome assessment is amblyopic eye visual acuity at 10 weeks.

The primary analytic approach for the amblyopic eye acuity will be a treatment group comparison of the proportion of patients with at least two lines of visual acuity improvement.

Detailed Description

Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children. Despite best efforts with conventional treatment, some patients fail to achieve normal visual acuity in the amblyopic eye. In a randomized trial conducted by PEDIG comparing atropine versus patching in 3 to 6 year olds with moderate amblyopia (ATS1), 261 of 402 patients (65%) had amblyopic eye visual acuity of 20/32 or worse after 6 months of treatment with patching or atropine. Beyond 6 months, treatment was at investigator discretion, and two years after randomization, 181 of 363 children (50%) still had amblyopic eye visual acuity of 20/32 or worse. In a randomized trial conducted by PEDIG comparing patching regimens, 129 of 181 patients with moderate amblyopia (71%) and 145 of 157 patients with severe amblyopia (92%) had amblyopic eye visual acuity of 20/32 or worse after 4 months of occlusion therapy. Many patients receive treatment beyond 6 months but still fail to achieve normal visual acuity in the amblyopic eye. It is unknown whether an intensive "final push" of combined treatment with daily patching and atropine will improve visual acuity in these patients. Although some clinicians prescribe simultaneous patching and atropine for selected patients, there are no published reports of its effectiveness. Also, we are not aware of reports of response to treatment of residual amblyopia.

The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. Patients will be randomized to one of two treatment regimens:

  • Intensive treatment: 42 hours per week of patching combined with daily atropine (1%)
  • Control group: Weaning of the current treatment (two hours of daily patching for patients currently using patching and once weekly atropine for patients currently using atropine) for 4 weeks, then no treatment other than spectacles (if needed).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amblyopia
Intervention  ICMJE
  • Device: Patching
    42 hours per week of patching
    Other Name: Coverlet, 3M Opticlude, Ortopad®
  • Drug: Atropine
    daily atropine (1%)
  • Device: Patching
    two hours of daily patching for 4 weeks, then no treatment
    Other Name: Coverlet, 3M Opticlude, Ortopad®
  • Drug: Atropine
    once weekly atropine for 4 weeks, then no treatment
Study Arms  ICMJE
  • Active Comparator: Intensive
    42 hours per week of patching combined with atropine (1%) once daily in the sound eye, with spectacle correction (if needed)
    Interventions:
    • Device: Patching
    • Drug: Atropine
  • Active Comparator: Weaning
    For patients currently patching, reduce patching to two hours daily for four weeks, then no treatment thereafter except spectacle correction (if needed). For patients currently using atropine, reduce atropine to once weekly for 4 weeks, then no treatment thereafter except spectacle correction (if needed)
    Interventions:
    • Device: Patching
    • Drug: Atropine
Publications * Pediatric Eye Disease Investigator Group (PEDIG) Writing Committee, Wallace DK, Kraker RT, Beck RW, Cotter SA, Davis PL, Holmes JM, Repka MX, Suh DW. Randomized trial to evaluate combined patching and atropine for residual amblyopia. Arch Ophthalmol. 2011 Jul;129(7):960-2. doi: 10.1001/archophthalmol.2011.174.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 15, 2010)
55
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2007)
240
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 3 to < 10 years
  • Amblyopia associated with strabismus, anisometropia, or both
  • Visual acuity in the amblyopic eye between 20/32 and 20/63 inclusive
  • Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >= 2 logMAR lines
  • Current/previous treatment with patching and/or atropine subject to the following stipulations:

    • No simultaneous treatment with patching and atropine in the past 6 months
    • No prior use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D
    • Maximum level of any previous treatment:

      • Patching: up to 42 hours per week (averaging 6 hours daily)
      • Atropine: up to once daily
    • Current treatment with 42 hours per week patching or daily atropine
  • No improvement in best-corrected amblyopic eye visual acuity between two consecutive visits at least 6 weeks apart using the same testing method and optimal spectacle correction (if needed), with no improvement defined as follows:

    • No lines of improvement
    • For patients tested using E-ETDRS, letter score that is no more than 4 letters improved
  • Wearing spectacles with optimal correction (if applicable)
  • Investigator ready to wean or stop treatment

Exclusion Criteria:

  • Current vision therapy or orthoptics
  • Ocular cause for reduced visual acuity
  • Prior intraocular or refractive surgery
  • Strabismus surgery planned within 10 weeks
  • Known allergy to atropine or other cycloplegic drugs
  • Known skin reactions to patch or bandage adhesives
  • Down Syndrome present
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00506675
Other Study ID Numbers  ICMJE NEI-135
2U10EY011751 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ray Kraker, Jaeb Center for Health Research
Study Sponsor  ICMJE Jaeb Center for Health Research
Collaborators  ICMJE National Eye Institute (NEI)
Investigators  ICMJE
Study Chair: David K. Wallace, M.D. Duke University Eye Center
PRS Account Jaeb Center for Health Research
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP