Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study has been completed.
Sponsor:
Collaborator:
National Eye Institute (NEI)
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
History of Changes
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
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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

Baseline Measures
    Control     Intensified Treatment     Total  
Number of Participants  
[units: participants]
 		  83     86     169  
Age  
[units: participants]
 		     
<=18 years     83     86     169  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  5.9  ± 1.3     5.9  ± 1.2     5.9  ± 1.3  
Age, Customized [1]
[units: participants]
 		     
3 to <4 years     5     8     13  
4 to <5 years     15     15     30  
5 to <6 years     27     19     46  
6 to <7 years     17     25     42  
7 to 8 years     19     19     38  
Gender  
[units: participants]
 		     
Female     43     43     86  
Male     40     43     83  
Race/Ethnicity, Customized  
[units: participants]
 		     
White     57     66     123  
Black/African American     8     2     10  
Hispanic     14     14     28  
Asian     2     3     5  
More than one race     2     1     3  
Region of Enrollment  
[units: participants]
 		     
United States     80     82     162  
United Kingdom     3     3     6  
Canada     0     1     1  
Enrollment Disposition [2]
[units: participants]
 		     
No current treatment     48     49     97  
On treatment     18     18     36  
Ready for randomization     17     19     36  
Duration of patching prior to randomization (weeks)  
[units: participants]
 		     
12 to <16 weeks     14     21     35  
16 to <25 weeks     39     31     70  
25 weeks or more     30     34     64  
Duration of patching prior to randomization (weeks)  
[units: Weeks]
Mean ± Standard Deviation 		  24.5  ± 10.7     24.4  ± 11.9     24.4  ± 11.3  
Amblyopia Cause [3]
[units: participants]
 		     
Strabismus     16     16     32  
Anisometropia     41     34     75  
Strabismus and Anisometropia     26     36     62  
Best distance visual acuity in the amblyopic eye at randomization [4]
[units: participants]
 		     
20/160     2     3     5  
20/125     3     1     4  
20/100     2     7     9  
20/80     6     6     12  
20/63     17     21     38  
20/50     26     24     50  
20/40     21     18     39  
20/32     6     6     12  
Best distance visual acuity in the amblyopic eye at randomization [4]
[units: logMAR]
Mean ± Standard Deviation 		  0.43  ± 0.15     0.45  ± 0.16     0.44  ± 0.16  
Best distance visual acuity in the fellow eye at randomization [5]
[units: participants]
 		     
20/32     5     5     10  
20/25     17     21     38  
20/20     27     26     53  
20/16     34     34     68  
Best distance visual acuity in the fellow eye at randomization [5]
[units: logMAR]
Mean ± Standard Deviation 		  -0.01  ± 0.09     0.00  ± 0.09     -0.01  ± 0.09  
Best interocular eye visual acuity difference at randomization [6]
[units: logMAR lines]
Mean ± Standard Deviation 		  4.4  ± 1.6     4.5  ± 1.7     4.5  ± 1.7  
Refractive error in amblyopic eye at enrollment  
[units: participants]
 		     
0 to <+1.00D     9     3     12  
+1.00 D to <+2.00 D     5     3     8  
+2.00 D to <+3.00 D     2     4     6  
+3.00 D to <+4.00 D     13     6     19  
+4.00 D or more     54     70     124  
Refractive error in amblyopic eye at enrollment  
[units: Diopters]
Mean ± Standard Deviation 		  4.58  ± 2.26     5.27  ± 1.94     4.93  ± 2.12  
Refractive error in fellow eye at enrollment  
[units: participants]
 		     
<0 D     1     1     2  
0 to <+1.00D     22     14     36  
+1.00 D to <+2.00 D     30     19     49  
+2.00 D to <+3.00 D     10     14     24  
+3.00 D to <+4.00 D     4     12     16  
+4.00 D or more     16     26     42  
Refractive error in fellow eye at enrollment  
[units: Diopters]
Mean ± Standard Deviation 		  2.10  ± 1.86     2.89  ± 2.06     2.50  ± 2.00  
[1]

Baseline age reflects age at randomization.

The age eligibility requirement at enrollment was 3 to <8 years old, however, there were 7 participants who were enrolled into the run-in phase that were 8 years old by the time they were randomized.
[2] Participants were classified into 3 groups (no current treatment, on treatment, ready for randomization) according to their treatment disposition at enrollment.
[3]

Amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both:

Criteria for strabismus: At least one of the following:

  1. Heterotropia at distance and/or near fixation on examination (with or without spectacles)
  2. History of strabismus surgery
  3. Documented history which is no longer present (which in the judgement of the investigator could have caused amblyopia)

Criteria for anisometropia: At least one of the following:

  1. At least 0.50 D difference between eyes in spherical equivalent
  2. At least 1.50 D different between eyes in astigmatism in any meridian
[4]

Visual acuity was measured without cycloplegia using the participant's optimal spectacle correction (if applicable) by a study-certified tester using the ATS-HOTV protocol on the Electronic Visual Acuity Tester.

Best amblyopic eye visual acuity was computed as the better of the initial test and retest visual acuities at randomization.
[5]

Visual acuity was measured without cycloplegia using the participant's optimal spectacle correction (if applicable) by a study-certified tester using the ATS-HOTV protocol on the Electronic Visual Acuity Tester.

Best fellow eye visual acuity was computed as the better of the initial test and retest visual acuities at randomization.
[6] Best interocular eye visual acuity difference was computed as difference between the best amblyopic eye visual acuity and the best fellow eye visual acuity at randomization.



  Outcome Measures
  Show All Outcome Measures

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

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

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

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

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

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

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 ]
  Show Outcome Measure 7

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

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

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

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

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

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

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

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 ]
  Show Outcome Measure 15

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 ]
  Show Outcome Measure 16

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

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

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

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

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

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

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

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

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

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

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

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

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

Measure Type Secondary
Measure Title Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia
Measure Description No text entered.
Time Frame 10 weeks after randomization  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 10-week exam.

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

Measured Values
    Control     Intensified Treatment  
Number of Participants Analyzed  
[units: participants]
 		  40     32  
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia  
[units: participants]
 		   
Failed pretest     3     2  
> 800 seconds of arc     11     17  
800 seconds of arc     7     4  
400 seconds of arc     6     4  
200 seconds of arc     4     3  
100 seconds of arc     7     0  
60 seconds of arc     0     1  
40 seconds of arc     2     1  
Not done     0     0  

No statistical analysis provided for Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia



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 ]
  Show Outcome Measure 30


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show 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
  Show More Information