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Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old (ATS16)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00944710
First received: July 21, 2009
Last updated: October 22, 2014
Last verified: October 2014
Results First Received: October 9, 2014  
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: Plano lens

  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 November 2009 and August 2013, 73 participants from 20 sites were randomly assigned to either augmenting weekend atropine by changing the lens over the fellow eye to plano (n=33) or continuing with weekend atropine with best spectacle correction (n=40).

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 completed at least 12 weeks of atropine were enrolled into a run-in phase and treated with weekend atropine 1% ophthalmic solution and spectacles based upon a recent cycloplegic refraction, with follow up every 6 weeks until no improvement

Reporting Groups
  Description
Control

Weekend atropine 1%

Atropine: Weekend atropine 1%

Intensified Treatment

Weekend atropine 1% with plano lens over the sound eye

Atropine: Weekend atropine 1%

Plano lens: plano lens over the sound eye


Participant Flow for 3 periods

Period 1:   10-week Primary Outcome
    Control     Intensified Treatment  
STARTED     40     33  
COMPLETED     40     33  
NOT COMPLETED     0     0  

Period 2:   12-week Visit (Off-treatment)
    Control     Intensified Treatment  
STARTED     40     33  
COMPLETED     40     33  
NOT COMPLETED     0     0  

Period 3:   Additional Post 10-week Primary Outcome
    Control     Intensified Treatment  
STARTED     40     33  
Eligible to Enter Post 10-week Phase     24     26  
COMPLETED     23     22  
NOT COMPLETED     17     11  



  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
Control

Weekend atropine 1%

Atropine: Weekend atropine 1%

Intensified Treatment

Weekend atropine 1% with plano lens over the sound eye

Atropine: Weekend atropine 1%

Plano lens: plano lens over the sound eye

Total Total of all reporting groups

Baseline Measures
    Control     Intensified Treatment     Total  
Number of Participants  
[units: participants]
  40     33     73  
Age  
[units: participants]
     
<=18 years     40     33     73  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  5.8  ± 1.5     5.8  ± 1.4     5.8  ± 1.4  
Age, Customized [1]
[units: participants]
     
3 to <4 years     5     4     9  
4 to <5 years     8     6     14  
5 to <6 years     9     9     18  
6 to <7 years     7     5     12  
>=7 years     11     9     20  
Gender  
[units: participants]
     
Female     22     19     41  
Male     18     14     32  
Race/Ethnicity, Customized  
[units: participants]
     
White     33     29     62  
African American     3     1     4  
Hispanic     4     3     7  
Region of Enrollment  
[units: participants]
     
United States     40     33     73  
Duration of Atropine Treatment Prior to Randomization  
[units: participants]
     
12 to <15 weeks     11     5     16  
15 to <21 weeks     6     9     15  
21 to <27 weeks     13     9     22  
27 to 84 weeks     10     10     20  
Duration of Atropine Treatment Prior to Randomization  
[units: weeks]
Mean ± Standard Deviation
  24.0  ± 11.2     26.4  ± 14.6     25.0  ± 12.8  
Cause of Amblyopia [2]
[units: participants]
     
Strabismus     9     13     22  
Anisometropia     10     6     16  
Strabismus and Anisometropia     21     14     35  
Distance Visual Acuity in the Amblyopic Eye at Randomization [3]
[units: participants]
     
20/160     2     1     3  
20/125     2     2     4  
20/100     5     1     6  
20/80     2     6     8  
20/63     9     8     17  
20/50     7     8     15  
20/40     11     6     17  
20/32     2     1     3  
Distance Visual Acuity in the Amblyopic Eye at Randomization [3]
[units: logMAR]
Mean ± Standard Deviation
  0.48  ± 0.19     0.48  ± 0.16     0.48  ± 0.18  
Distance Visual Acuity in the Fellow Eye at Randomization [3]
[units: participants]
     
20/32     5     6     11  
20/25     13     9     22  
20/20     16     13     29  
20/16     6     5     11  
Distance Visual Acuity in the Fellow Eye at Randomization [3]
[units: logMAR]
Mean ± Standard Deviation
  0.04  ± 0.09     0.05  ± 0.10     0.05  ± 0.09  
Interocular Eye Visual Acuity Difference at Randomization  
[units: logMAR lines]
Mean ± Standard Deviation
  4.4  ± 1.8     4.4  ± 1.7     4.4  ± 1.7  
Spherical Equivalent Refractive Error in Amblyopic Eye at Enrollment  
[units: participants]
     
0 to <+1.00 D     0     0     0  
+1.00 to <+2.00 D     0     1     1  
+2.00 to <+3.00 D     1     1     2  
+3.00 to <+4.00 D     6     5     11  
+4.00 D or more     33     26     59  
Spherical Equivalent Refractive Error in Amblyopic Eye at Enrollment  
[units: diopters]
Mean ± Standard Deviation
  5.73  ± 1.62     5.84  ± 1.89     5.78  ± 1.74  
Spherical Equivalent Refractive Error in Fellow Eye at Enrollment  
[units: participants]
     
+1.50 to <+2.00 D     5     5     10  
+2.00 to <+3.00 D     6     2     8  
+3.00 to <+4.00 D     7     9     16  
+4.00 D or more     22     17     39  
Spherical Equivalent Refractive Error in Fellow Eye at Enrollment  
[units: diopters]
Mean ± Standard Deviation
  3.95  ± 1.60     4.55  ± 2.28     4.22  ± 1.95  
[1]

Baseline age reflects age at randomization.

The age eligibility requirement at enrollment was 3 to <8 years old; however, four participants (2 in each group) were <8 years old at time of enrollment into the run-in phase and ≥ 8 years old at time of randomization (8.0 and 8.1 in the atropine only group, and 8.1 and 8.3 in the atropine plus plano lens group).

[2]

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



  Outcome Measures
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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   [ 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:   Treatment Group Comparison of the Proportion of Participants Who Achieved 20/25 or Better Visual Acuity at 10 Weeks Since Randomization   [ Time Frame: 10 weeks after randomization ]

6.  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 ]

7.  Secondary:   Spectacle Compliance at 10 Weeks by Treatment Group   [ Time Frame: 10 weeks after randomization ]

8.  Secondary:   Average Spectacle Compliance by Treatment Group   [ Time Frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject) ]

9.  Secondary:   Atropine Compliance at 10 Weeks by Treatment Group   [ Time Frame: 10 weeks after randomization ]

10.  Secondary:   Average Atropine Compliance by Treatment Group   [ Time Frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject) ]

11.  Secondary:   Distribution of Interocular Difference at 12-week Exam   [ Time Frame: 12 weeks after randomization ]

12.  Secondary:   Mean Interocular Difference at 12-week Exam   [ Time Frame: 12 weeks after randomization ]

13.  Secondary:   Distribution of 12-week Fellow-Eye Visual Acuity   [ Time Frame: 12 weeks after randomization ]

14.  Secondary:   Mean Fellow-Eye Visual Acuity at 12-week Exam   [ Time Frame: 12 weeks after randomization ]

15.  Secondary:   Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization   [ Time Frame: 12 weeks after randomization ]

16.  Secondary:   Mean Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization   [ Time Frame: 12 weeks after randomization ]

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

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

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

20.  Secondary:   Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit   [ Time Frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject) ]

21.  Secondary:   Mean Amblyopic-Eye Visual Acuity at Best Outcome Visit   [ Time Frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject) ]

22.  Secondary:   Distribution of Change in Amblyopic-Eye Visual Acuity From Randomization to Best Outcome Visit   [ Time Frame: Randomization to 10 weeks or later (until no further VA improvement, up to maximum of 84 weeks for one subject) ]

23.  Secondary:   Mean Change in Amblyopic-Eye Visual Acuity at Best Outcome Visit   [ Time Frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject) ]

24.  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 Outcome Visit   [ Time Frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject) ]

25.  Secondary:   Distribution of Randot Preschool Stereoacuity Score at 12 Weeks   [ Time Frame: 12 weeks after randomization ]

26.  Secondary:   Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia   [ Time Frame: 12 weeks after randomization ]


  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
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
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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, M.S.P.H., Director of PEDIG Coordinating Center
Organization: Jaeb Center for Health Research
phone: 813-975-8690
e-mail: rkraker@jaeb.org


No publications provided


Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00944710     History of Changes
Other Study ID Numbers: NEI-144, 2U10EY011751
Study First Received: July 21, 2009
Results First Received: October 9, 2014
Last Updated: October 22, 2014
Health Authority: United States: Food and Drug Administration