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Trial Comparing Patching With Active Vision Therapy to Patching With Control Vision Therapy as Treatment for Amblyopia (ATS12)

This study has been terminated.
(This study was stopped due to insufficient recruitment.)
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Ray Kraker, Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00587171
First received: December 10, 2007
Last updated: May 16, 2012
Last verified: May 2012
History of Changes
Results First Received: April 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Amblyopia
Interventions: Device: Patching
Procedure: Near activities
Procedure: Active vision therapy
Procedure: Control vision therapy

  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
Nineteen subjects were recruited by 7 community based or institutional based sites between April 2008 and March 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At enrollment, subjects were required to have been treated with at least 16 weeks of single vision spectacles (if needed) or until visual acuity was documented to be stable. The child must have had access to a computer on a daily basis.

Reporting Groups
  Description
Active 2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
Control 2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy

Participant Flow:   Overall Study
    Active     Control  
STARTED     9     10  
COMPLETED     8     9  
NOT COMPLETED     1     1  
Lost to Follow-up                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Active 2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
Control 2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
Total Total of all reporting groups

Baseline Measures
    Active     Control     Total  
Number of Participants  
[units: participants]
 		  9     10     19  
Age [1]
[units: years]
Mean ± Standard Deviation 		  10.1  ± 2.1     10.0  ± 1.8     10.0  ± 1.9  
Age, Customized [1]
[units: participants]
 		     
7 years old     1     2     3  
8 years old     2     1     3  
9 years old     2     2     4  
10 years old     1     0     1  
11 years old     0     4     4  
12 years old     3     1     4  
Gender  
[units: participants]
 		     
Female     6     5     11  
Male     3     5     8  
Race/Ethnicity, Customized  
[units: participants]
 		     
White     3     5     8  
Black/African American     0     1     1  
Hispanic     6     4     10  
Region of Enrollment  
[units: participants]
 		     
United States     9     10     19  
Cause of Amblyopia  
[units: participants]
 		     
Anisometropia     4     5     9  
Strabismus     0     2     2  
Strabismus and anisometropia     5     3     8  
Distance visual acuity in amblyopic eye [2]
[units: participants]
 		     
20/100 (48 to 52 letters) (worse)     2     2     4  
20/80 (53 to 57 letters)     0     1     1  
20/63 (58 to 62 letters)     1     1     2  
20/50 (63 to 67 letters)     4     2     6  
20/40 (68 to 72 letters) (best)     2     4     6  
Mean (SD) Distance Visual Acuity in Amblyopic Eye [2]
[units: letters]
Mean ± Standard Deviation 		  62.3  ± 6.8     61.9  ± 7.9     62.1  ± 7.2  
Distance visual acuity in fellow eye [2]
[units: participants]
 		     
20/40 (68 to 72 letters) (worse)     0     0     0  
20/32 (73 to 77 letters)     0     0     0  
20/25 (78 to 82 letters)     2     2     4  
20/20 (83 to 87 letters)     4     5     9  
20/16 (88 to 92 letters) (best)     3     3     6  
Mean (SD) Distance Visual Acuity in Fellow Eye [2]
[units: letters]
Mean ± Standard Deviation 		  85.3  ± 3.6     86.2  ± 4.0     85.8  ± 3.8  
Mean (SD) Intereye Acuity Difference [3]
[units: letters]
Mean ± Standard Deviation 		  23.0  ± 6.5     24.3  ± 8.8     23.7  ± 7.6  
Randot Preschool stereoacuity [4]
[units: participants]
 		     
40 arcsec     0     0     0  
60 arcsec     0     0     0  
100 arcsec     2     4     6  
200 arcsec     3     2     5  
400 arcsec     1     2     3  
800 arcsec     3     2     5  
>800 arcsec     0     0     0  
Failed pretest     0     0     0  
[1] Age at enrollment in years
[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] The difference between eyes in letters was calculated with positive values indicating sound eye better.
[4] 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.



  Outcome Measures
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1.  Primary:   Distribution of Distance Visual Acuity in Amblyopic Eye at 17-week Outcome   [ Time Frame: 17 weeks ]
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2.  Primary:   Mean (SD): Distance Visual Acuity in Amblyopic Eye at 17-week Outcome   [ Time Frame: 17 weeks ]
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3.  Primary:   Distribution of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks   [ Time Frame: Baseline to 17 weeks ]
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4.  Primary:   Mean (SD) of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks   [ Time Frame: Baseline to 17 weeks ]
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5.  Secondary:   Distribution of Fellow Eye Visual Acuity at 17 Weeks   [ Time Frame: 17 weeks ]
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6.  Secondary:   Mean (SD) of Fellow Eye Visual Acuity at 17 Weeks   [ Time Frame: 17 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Distribution of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks   [ Time Frame: Baseline to 17 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Mean (SD) of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks   [ Time Frame: Baseline to 17 weeks ]
  Hide Outcome Measure 8

Measure Type Secondary
Measure Title Mean (SD) of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks
Measure Description Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and 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 was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.
Time Frame Baseline to 17 weeks  
Safety Issue No  

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
Active 2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
Control 2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy

Measured Values
    Active     Control  
Number of Participants Analyzed  
[units: participants]
 		  8     9  
Mean (SD) of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks  
[units: letters]
Mean ± Standard Deviation 		  0.4  ± 2.8     2.9  ± 2.7  

No statistical analysis provided for Mean (SD) of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks



9.  Secondary:   Mean (SD) of Intereye Visual Acuity at 17 Weeks   [ Time Frame: 17 weeks ]
  Show Outcome Measure 9

10.  Secondary:   Mean (SD) of Change in Intereye Visual Acuity From Baseline to 17 Weeks   [ Time Frame: Baseline to 17 weeks ]
  Show Outcome Measure 10

11.  Secondary:   Distribution of Randot Preschool Stereoacuity at 17 Weeks   [ Time Frame: 17 weeks ]
  Show Outcome Measure 11

12.  Secondary:   Distribution of Change in Randot Preschool Steroacuity From Baseline to 17 Weeks   [ Time Frame: Baseline to 17 weeks ]
  Show Outcome Measure 12


  Serious Adverse Events
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  Other Adverse Events
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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.


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
The study was stopped prior to achieving the goal of 45 subjects enrolled due to slow recruitment, leaving only 19 subjects enrolled.  


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


No publications provided


Responsible Party: Ray Kraker, Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00587171     History of Changes
Other Study ID Numbers: NEI-138, 2U10EY011751
Study First Received: December 10, 2007
Results First Received: April 22, 2011
Last Updated: May 16, 2012
Health Authority: United States: Federal Government