Increasing Patching for Amblyopia in Children 3 to < 8 Years Old (ATS15)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00945100
First received: July 21, 2009
Last updated: September 6, 2013
Last verified: September 2013
Results First Received: September 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Amblyopia
Intervention: Device: Eye Patch

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between September 2009 and December 2012, 45 sites randomized 169 participants to either increase patching time to an average of 6 hours per day (n=86) or continue 2 hours daily patching (n=83).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to being considered for the randomized trial, participants who had not already completed at least 12 weeks of 2 hours of daily patching were enrolled into a run-in phase and treated with 2 hours of daily patching (and spectacles if needed) with follow-up every 6 weeks until no improvement.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Participant Flow for 2 periods

Period 1:   10-week Primary Outcome
    Control     Intensified Treatment  
STARTED     83     86  
COMPLETED     82     83  
NOT COMPLETED     1     3  

Period 2:   Post-10 Week Primary Outcome
    Control     Intensified Treatment  
STARTED     55     63  
COMPLETED     51     56  
NOT COMPLETED     4     7  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Distribution of 10-week Amblyopic Eye Visual Acuity   [ Time Frame: 10 weeks after randomization ]

2.  Primary:   Mean 10-week Amblyopic Eye Visual Acuity   [ Time Frame: 10 weeks after randomization ]

3.  Primary:   Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization   [ Time Frame: Randomization to 10 weeks ]

4.  Primary:   Mean Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization   [ Time Frame: Randomization to 10 weeks ]

5.  Secondary:   Compliance With Prescribed Patching by Treatment Group at 10 Weeks   [ Time Frame: 10 weeks after randomization ]

6.  Secondary:   Average Compliance With Prescribed Patching by Treatment Group   [ Time Frame: 10 weeks after randomization or later ]

7.  Secondary:   Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization   [ Time Frame: 10 weeks after randomization ]

8.  Secondary:   Treatment Group Comparison of 10-week Interocular Difference   [ Time Frame: 10 weeks after randomization ]

9.  Secondary:   Distribution of Baseline Characteristics at the 10-week Outcome   [ Time Frame: 10 weeks after randomization ]

10.  Secondary:   Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome   [ Time Frame: 10 weeks after randomization ]

11.  Secondary:   Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics   [ Time Frame: 10 weeks after randomization ]

12.  Secondary:   Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity   [ Time Frame: 10 weeks after randomization or later ]

13.  Secondary:   Mean Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity   [ Time Frame: 10 weeks after randomization or later ]

14.  Secondary:   Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye   [ Time Frame: Randomization to 10 weeks or later ]

15.  Secondary:   Mean Change in Amblyopic Eye Visual Acuity Since Randomization at Visit of Best Post-randomization Visual Acuity   [ Time Frame: 10 weeks after randomization or later ]

16.  Secondary:   Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Post-randomization Visit   [ Time Frame: 10 weeks after randomization or later ]

17.  Secondary:   Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome   [ Time Frame: 10 weeks after randomization ]

18.  Secondary:   Mean Best Fellow Eye Visual Acuity at 10-week Outcome   [ Time Frame: 10 weeks after randomization ]

19.  Secondary:   Distribution of Best Fellow Eye Visual Acuity at Final Visit   [ Time Frame: 10 weeks after randomization or later ]

20.  Secondary:   Mean Best Fellow Eye Visual Acuity at Final Visit   [ Time Frame: 10 weeks after randomization or later ]

21.  Secondary:   Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks   [ Time Frame: 10 weeks after randomization ]

22.  Secondary:   Mean Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks   [ Time Frame: 10 weeks after randomization ]

23.  Secondary:   Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit   [ Time Frame: 10 weeks after randomization or later ]

24.  Secondary:   Mean Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit   [ Time Frame: 10 weeks after randomization or later ]

25.  Secondary:   Distribution of Randot Preschool Stereoacuity Scores at Randomization   [ Time Frame: Randomization ]

26.  Secondary:   Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks   [ Time Frame: 10 weeks after randomization ]

27.  Secondary:   Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization   [ Time Frame: 10 weeks after randomization ]

28.  Secondary:   Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia   [ Time Frame: Randomization ]

29.  Secondary:   Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia   [ Time Frame: 10 weeks after randomization ]

30.  Secondary:   Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia   [ Time Frame: 10 weeks after randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
A potential study limitation is that compliance with patching was based on discussions with the parent and by reviewing study calendars maintained by the parent, which not an objective measure of compliance.


  More Information