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Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds (ATS9)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ray Kraker, Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00315328
First received: April 14, 2006
Last updated: May 16, 2012
Last verified: May 2012
Results First Received: September 9, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Amblyopia
Interventions: Drug: Atropine
Device: Patching
Procedure: Near activities

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between August 2005 and July 2007, 233 subjects were randomized at 39 certified sites (193 with moderate amblyopia 20/40 to 20/100 in a primary cohort, and an additional 40 with severe amblyopia 20/125 to 20/400 that were followed as a secondary cohort).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects must have been wearing optimal spectacle correction for a minimum of 16 weeks or until stability of visual acuity was documented (no improvement in amblyopic eye visual acuity at 2 consecutive visits at least 4 weeks apart) before enrollment and randomization.

Reporting Groups
  Description
Patching-Moderate Amblyopia Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
Atropine-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
Patching-Severe Amblyopia Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
Atropine-Severe Amblyopia Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).

Participant Flow:   Overall Study
    Patching-Moderate Amblyopia     Atropine-Moderate Amblyopia     Patching-Severe Amblyopia     Atropine-Severe Amblyopia  
STARTED     98 [1]   95 [1]   18 [2]   22 [2]
5 Week Visit     91     89     17     19  
COMPLETED     84 [3]   88 [3]   13 [3]   20 [3]
NOT COMPLETED     14     7     5     2  
[1] Includes subjects with moderate amblyopia only (20/40 to 20/100 at baseline)
[2] Includes subjects with severe amblyopia only (20/125 to 20/400 at baseline)
[3] Completed defined as completing 17 week primary outcome exam



  Baseline Characteristics
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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
Patching-Moderate Amblyopia Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
Atropine-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
Patching-Severe Amblyopia Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
Atropine-Severe Amblyopia Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
Total Total of all reporting groups

Baseline Measures
    Patching-Moderate Amblyopia     Atropine-Moderate Amblyopia     Patching-Severe Amblyopia     Atropine-Severe Amblyopia     Total  
Number of Participants  
[units: participants]
  98     95     18     22     233  
Age [1]
[units: years]
Mean ± Standard Deviation
  8.9  ± 1.5     9.1  ± 1.6     9.5  ± 1.5     9.2  ± 1.8     9.0  ± 1.6  
Age, Customized [1]
[units: participants]
         
7 to <8 years     35     28     6     9     78  
8 to <9 years     24     26     0     4     54  
9 to <10 years     17     16     5     3     41  
10 to <11 years     8     10     4     2     24  
11 to <12 years     8     7     2     1     18  
12 to <13 years     6     8     1     3     18  
Gender  
[units: participants]
         
Female     48     54     4     12     118  
Male     50     41     14     10     115  
Race/Ethnicity, Customized  
[units: participants]
         
White     68     56     16     18     158  
African-American     8     11     2     1     22  
Hispanic or Latino     20     23     0     3     46  
Asian     0     1     0     0     1  
More than one race     1     2     0     0     3  
Not reported     1     2     0     0     3  
Cause of Amblyopia  
[units: participants]
         
Strabismus     28     33     4     4     69  
Anisometropia     46     31     6     9     92  
Strabismus and anisometropia     24     31     8     9     72  
Distance Visual Acuity in Amblyopic Eye [2]
[units: participants]
         
20/400 (18 to 22 letters) (worse)     0     0     0     1     1  
20/320 (23 to 27 letters)     0     0     0     1     1  
20/250 (28 to 32 letters)     0     0     2     4     6  
20/200 (33 to 37 letters)     0     0     8     3     11  
20/160 (38 to 42 letters)     0     0     5     4     9  
20/125 (43 to 47 letters)     0     0     3     9     12  
20/100 (48 to 52 letters)     6     13     0     0     19  
20/80 (53 to 57 letters)     15     13     0     0     28  
20/63 (58 to 62 letters)     24     22     0     0     46  
20/50 (63 to 67 letters)     33     28     0     0     61  
20/40 (68 to 72 letters) (best)     20     19     0     0     39  
Distance Visual Acuity in Fellow Eye [2]
[units: participants]
         
20/32 (73 to 77 letters) (worse)     0     0     0     0     0  
20/25 (78 to 82 letters)     17     20     1     6     44  
20/20 (83 to 87 letters)     43     47     8     5     103  
20/16 (88 to 92 letters)     36     26     9     11     82  
20/12 (93 to 97 letters) (best)     2     2     0     0     4  
Prior Treatment for Amblyopia at Enrollment  
[units: participants]
         
None     71     68     13     18     170  
Patching     16     16     2     3     37  
Atropine     2     0     1     0     3  
Patching and atropine     9     11     2     1     23  
Refractive Error in Amblyopic Eye (spherical equivalent) [3]
[units: participants]
         
< 0 Diopters (D)     2     2     0     0     4  
0 to < +1.00D     8     10     1     1     20  
+1.00 to < +2.00D     13     6     2     2     23  
+2.00 to < +3.00D     10     8     1     3     22  
+3.00 to < +4.00D     23     16     2     4     45  
>= +4.00D     42     53     12     12     119  
Refractive Error in Fellow Eye (spherical equivalent) [3]
[units: participants]
         
< 0 Diopters (D)     1     2     0     0     3  
0 to < +1.00D     32     29     4     9     74  
+1.00 to < +2.00D     33     17     8     5     63  
+2.00 to < +3.00D     13     9     1     2     25  
+3.00 to < +4.00D     7     6     2     2     17  
>= +4.00D     12     32     3     4     51  
Distance Visual Acuity in Amblyopic Eye [2]
[units: ETDRS letter score]
Mean ± Standard Deviation
  62.4  ± 5.7     61.7  ± 6.6     37.5  ± 5.0     37.5  ± 7.5     57.9  ± 11.1  
Distance Visual Acuity in Fellow Eye [2]
[units: ETDRS letter score]
Mean ± Standard Deviation
  86.0  ± 3.6     85.7  ± 3.4     87.0  ± 3.5     85.5  ± 4.0     85.9  ± 3.6  
Intereye Acuity Difference [4]
[units: ETDRS letter score]
Mean ± Standard Deviation
  23.5  ± 6.8     24.0  ± 7.0     49.5  ± 5.5     47.5  ± 9.5     28.0  ± 11.7  
Refractive Error in Amblyopic Eye (spherical equivalent [3]
[units: diopter]
Mean ± Standard Deviation
  3.57  ± 2.07     4.10  ± 2.19     4.97  ± 2.50     4.18  ± 1.99     3.95  ± 2.16  
Refractive Error in Fellow Eye (spherical equivalent) [3]
[units: diopter]
Mean ± Standard Deviation
  1.84  ± 1.74     2.56  ± 2.22     2.12  ± 1.76     1.98  ± 2.11     2.17  ± 2.00  
[1] Age at enrollment
[2] 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.
[3] Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. Spherical equivalent is defined as the sphere plus 1/2 the cylinder.
[4] 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. Intereye difference defined as the difference between ETDRS letter scores (amblyopic eye minus sound eye).



  Outcome Measures
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1.  Primary:   Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks   [ Time Frame: 17 weeks ]

2.  Primary:   Mean Visual Acuity in the Amblyopic Eye at 17 Weeks   [ Time Frame: 17 weeks ]

3.  Primary:   Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks   [ Time Frame: Baseline to 17 weeks ]

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

5.  Secondary:   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 ]

6.  Secondary:   Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only   [ Time Frame: 17 or 19 weeks ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only)   [ Time Frame: 17 weeks ]

10.  Secondary:   Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only)   [ Time Frame: 17 weeks ]

11.  Secondary:   Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only)   [ Time Frame: 17 weeks ]

12.  Secondary:   Distribution of Visual Acuity in the Fellow Eye at 17 Weeks   [ Time Frame: 17 weeks ]

13.  Secondary:   Mean Visual Acuity in the Fellow Eye at 17 Weeks   [ Time Frame: 17 weeks ]

14.  Secondary:   Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks   [ Time Frame: Baseline to 17 weeks ]

15.  Secondary:   Mean Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks   [ Time Frame: Baseline to 17 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Raymond Kraker
Organization: Jaeb Center for Health Research
phone: 813-975-8690
e-mail: pedig@jaeb.org


Publications of Results:
Other Publications:
Publications automatically indexed to this study:

Responsible Party: Ray Kraker, Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00315328     History of Changes
Other Study ID Numbers: NEI-119, 2U10EY011751
Study First Received: April 14, 2006
Results First Received: September 9, 2009
Last Updated: May 16, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration