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Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old (ATS8)

This study has been completed.
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Ray Kraker, Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00315302
First received: April 14, 2006
Last updated: May 16, 2012
Last verified: May 2012
History of Changes
Results First Received: August 3, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/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 Feb 2005 and May 2007, 240 subjects were randomized at 30 sites (180 with moderate amblyopia 20/40 to 20/100 in a primary cohort, and an additional 60 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 had stable visual acuity in glasses (if applicable) before enrollment and randomization.

Reporting Groups
  Description
Atropine-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine Plus Plano-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine-Severe Amblyopia Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
Atropine Plus Plano-Severe Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)

Participant Flow:   Overall Study
    Atropine-Moderate Amblyopia     Atropine Plus Plano-Moderate Amblyopia     Atropine-Severe Amblyopia     Atropine Plus Plano-Severe Amblyopia  
STARTED     90     90     26     34  
5 Week Visit     85     86     26     30  
10 Week Visit     86 [1]   85     24     29  
18 Week Primary Outcome Visit     84     88 [2]   24     31 [2]
Partial Responder Phase (Post 18 Weeks)     16 [3]   13 [3]   9 [3]   11 [3]
COMPLETED     84 [4]   88 [4]   24 [4]   31 [4]
NOT COMPLETED     6     2     2     3  
[1] Can be higher as includes subjects who may have missed the 5 week visit
[2] Can be higher as includes subjects who may have missed the 10 week or other visit
[3] Those who improved in the amblyopic eye at 18wk outcome continued on treatment w/ visits every 8wks.
[4] Completed defined as completing 18 week primary outcome exam



  Baseline Characteristics
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Reporting Groups
  Description
Atropine-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine Plus Plano-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine-Severe Amblyopia Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
Atropine Plus Plano-Severe Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
Total Total of all reporting groups

Baseline Measures
    Atropine-Moderate Amblyopia     Atropine Plus Plano-Moderate Amblyopia     Atropine-Severe Amblyopia     Atropine Plus Plano-Severe Amblyopia     Total  
Number of Participants  
[units: participants]
 		  90     90     26     34     240  
Age [1]
[units: participants]
 		         
<=18 years     90     90     26     34     240  
Between 18 and 65 years     0     0     0     0     0  
>=65 years     0     0     0     0     0  
Age [1]
[units: years]
Mean ± Standard Deviation 		  5.2  ± 1.1     5.1  ± 1.0     4.5  ± 0.9     4.4  ± 1.0     5.0  ± 1.1  
Gender  
[units: participants]
 		         
Female     47     47     8     16     118  
Male     43     43     18     18     122  
Race/Ethnicity, Customized  
[units: Participants]
 		         
White     75     70     23     28     196  
African-American     1     4     1     3     9  
Hispanic or Latino     12     14     2     3     31  
Asian     1     2     0     0     3  
Unknown / Not reported     1     0     0     0     1  
Region of Enrollment  
[units: participants]
 		         
United States     89     90     26     34     239  
Canada     1     0     0     0     1  
Cause of Amblyopia  
[units: participants]
 		         
Strabismus     38     37     10     11     96  
Anisometropia     32     30     5     8     75  
Strabismus and anisometropia     20     23     11     15     69  
Distance Visual Acuity in Amblyopic Eye [2]
[units: participants]
 		         
20/400 (worse)     0     0     0     8     8  
20/320     0     0     8     2     10  
20/250     0     0     1     3     4  
20/200     0     0     5     5     10  
20/160     0     0     5     5     10  
20/125     0     0     7     11     18  
20/100     7     15     0     0     22  
20/80     14     15     0     0     29  
20/63     29     28     0     0     57  
20/50     24     17     0     0     41  
20/40 (better)     16     15     0     0     31  
Distance Visual Acuity in Sound Eye [2]
[units: participants]
 		         
20/40 (worse)     3     3     4     7     17  
20/32     18     18     11     12     59  
20/25     27     28     8     7     70  
20/20     31     33     3     8     75  
20/16 (better)     11     8     0     0     19  
Prior Treatment for Amblyopia at Enrollment  
[units: participants]
 		         
None     76     72     24     28     200  
Patching     9     12     1     6     28  
Atropine     1     2     0     0     3  
Patching and Atropine     4     4     1     0     9  
Refractive Error in Amblyopic Eye (spherical equivalent/diopters) [3]
[units: participants]
 		         
0 to < +1.00 D     1     0     0     0     1  
+1.00 to < +2.00 D     0     6     1     0     7  
+2.00 D to < +3.00 D     8     6     3     0     17  
+3.00 D to < +4.00 D     13     15     3     4     35  
>= +4.00 D     68     63     19     30     180  
Refractive Error in Sound Eye (spherical equivalent/diopters) [3]
[units: participants]
 		         
+ 1.50 to < + 2.00 D     17     23     6     6     52  
+ 2.00 D to < + 3.00 D     14     19     8     5     46  
+3.00 D to < + 4.00 D     20     12     2     8     42  
>= + 4.00 D     39     36     10     15     100  
Distance Visual Acuity in Amblyopic Eye [2]
[units: log of min angle of resolution (logMAR)]
Mean ± Standard Deviation 		  0.47  ± 0.12     0.50  ± 0.13     0.99  ± 0.16     1.01  ± 0.20     0.61  ± 0.27  
Distance Visual Acuity in Sound Eye [2]
[units: log of min angle of resolution (logMAR)]
Mean ± Standard Deviation 		  0.07  ± 0.10     0.07  ± 0.10     0.16  ± 0.09     0.15  ± 0.11     .09  ± .11  
Intereye Acuity Difference [4]
[units: logMAR lines]
Mean ± Standard Deviation 		  4.0  ± 1.2     4.3  ± 1.3     8.3  ± 1.7     8.6  ± 2.2     5.2  ± 2.4  
Refractive Error in Amblyopic Eye (spherical equivalent/diopters) [3]
[units: diopters]
Mean ± Standard Deviation 		  4.99  ± 1.66     4.94  ± 1.81     5.25  ± 2.09     5.36  ± 1.29     5.05  ± 1.72  
Refractive Error in Sound Eye (spherical equivalent/diopters) [3]
[units: diopters]
Mean ± Standard Deviation 		  3.71  ± 1.71     3.54  ± 1.86     3.60  ± 2.18     3.71  ± 1.58     3.63  ± 1.79  
[1] Age at enrollment
[2]

Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.

20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst
[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] Intereye difference defined as the difference between logMAR scores (amblyopic eye minus sound eye)



  Outcome Measures
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1.  Primary:   Visual Acuity Mean Score in the Amblyopic Eye   [ Time Frame: 18 weeks ]

Measure Type Primary
Measure Title Visual Acuity Mean Score in the Amblyopic Eye
Measure Description

Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in an Snellen equivalent acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.

20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst
Time Frame 18 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.
Primary analysis includes only patients who completed the 18 week exam. No imputation was done if missed exam; analysis followed the intent to treat principle.

Reporting Groups
  Description
Atropine-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine Plus Plano-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine-Severe Amblyopia Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
Atropine Plus Plano-Severe Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)

Measured Values
    Atropine-Moderate Amblyopia     Atropine Plus Plano-Moderate Amblyopia     Atropine-Severe Amblyopia     Atropine Plus Plano-Severe Amblyopia  
Number of Participants Analyzed  
[units: participants]
 		  84     88     24     31  
Visual Acuity Mean Score in the Amblyopic Eye  
[units: logMAR units]
Mean ± Standard Deviation 		  0.23  ± 0.16     0.22  ± 0.20     0.54  ± 0.26     0.50  ± 0.38  


Statistical Analysis 1 for Visual Acuity Mean Score in the Amblyopic Eye
Groups [1] Atropine-Moderate Amblyopia vs. Atropine Plus Plano-Moderate Amblyopia
Method [2] ANCOVA
P Value [3] 0.21
Mean Difference (Final Values) [4] 0.3
Standard Deviation ± 0.24
95% Confidence Interval ( -0.2 to 0.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

The primary analysis was a treatment group comparison of logMAR visual acuity scores in the amblyopic eye obtained 18 weeks after randomization, adjusted for baseline acuity scores in an analysis of covariance (ANCOVA) model.

The primary analysis included only patients with visual acuity of 20/40 to 20/100; sample size was based upon a two-sided alpha of 0.05, with 90% power to detect a difference if the true difference in change from baseline between groups was 0.075 logMAR at 18 weeks.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The difference was calculated as atropine plus plano group minus atropine group



2.  Primary:   Visual Acuity Distribution in the Amblyopic Eye   [ Time Frame: 18 weeks ]

Measure Type Primary
Measure Title Visual Acuity Distribution in the Amblyopic Eye
Measure Description

Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.

20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst
Time Frame 18 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
Atropine-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine Plus Plano-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine-Severe Amblyopia Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
Atropine Plus Plano-Severe Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)

Measured Values
    Atropine-Moderate Amblyopia     Atropine Plus Plano-Moderate Amblyopia     Atropine-Severe Amblyopia     Atropine Plus Plano-Severe Amblyopia  
Number of Participants Analyzed  
[units: participants]
 		  84     88     24     31  
Visual Acuity Distribution in the Amblyopic Eye  
[units: Participants]
 		       
20/400 (worse)     0     0     0     1  
20/320     0     0     0     1  
20/250     0     0     1     2  
20/200     0     0     0     0  
20/160     0     1     2     1  
20/125     0     1     4     4  
20/100     2     1     1     2  
20/80     2     4     1     2  
20/63     4     6     5     2  
20/50     6     7     5     4  
20/40     18     9     3     0  
20/32     28     24     1     8  
20/25     12     19     0     1  
20/20     11     12     1     1  
20/16 (better)     1     4     0     2  


Statistical Analysis 1 for Visual Acuity Distribution in the Amblyopic Eye
Groups [1] Atropine-Moderate Amblyopia vs. Atropine Plus Plano-Moderate Amblyopia
Method [2] Regression, Logistic
P Value [3] .03
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

Null hypothesis: proportion 20/25 or better at 18wks in atropine group = proportion 20/25 or better at 18wks in atropine plus plano group

Alternative hypothesis: proportion 20/25 or better at 18wks in atropine group NOT equal to proportion 20/25 or better at 18wks in atropine plus plano group
[2] Other relevant information, such as adjustments or degrees of freedom:
  proportion 20/25 as a function of treatment group controlling for baseline acuity
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



3.  Primary:   Mean Change in Visual Acuity in the Amblyopic Eye   [ Time Frame: baseline to 18 weeks ]

Measure Type Primary
Measure Title Mean Change in Visual Acuity in the Amblyopic Eye
Measure Description

Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.

A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.
Time Frame baseline to 18 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
Atropine-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine Plus Plano-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine-Severe Amblyopia Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
Atropine Plus Plano-Severe Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)

Measured Values
    Atropine-Moderate Amblyopia     Atropine Plus Plano-Moderate Amblyopia     Atropine-Severe Amblyopia     Atropine Plus Plano-Severe Amblyopia  
Number of Participants Analyzed  
[units: participants]
 		  84     88     24     31  
Mean Change in Visual Acuity in the Amblyopic Eye  
[units: logMAR units]
Mean ± Standard Deviation 		  2.4  ± 1.4     2.8  ± 1.8     4.5  ± 3.1     5.1  ± 3.7  


Statistical Analysis 1 for Mean Change in Visual Acuity in the Amblyopic Eye
Groups [1] Atropine-Severe Amblyopia
Mean Difference (Final Values) [2] 4.5
Standard Deviation ± 3.1
95% Confidence Interval ( 3.2 to 5.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  95% confidence interval calculated within treatment group on the amount of change from baseline
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Mean Change in Visual Acuity in the Amblyopic Eye
Groups [1] Atropine Plus Plano-Severe Amblyopia
Mean Difference (Final Values) [2] 5.1
Standard Deviation ± 3.7
95% Confidence Interval ( 3.7 to 6.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  95% confidence interval calculated within treatment group on the amount of change from baseline
[2] Other relevant estimation information:
  No text entered.



4.  Primary:   Distribution of Change in Visual Acuity in the Amblyopic Eye   [ Time Frame: baseline to 18 weeks ]

Measure Type Primary
Measure Title Distribution of Change in Visual Acuity in the Amblyopic Eye
Measure Description

Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.

A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.
Time Frame baseline to 18 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
Atropine-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine Plus Plano-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine-Severe Amblyopia Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
Atropine Plus Plano-Severe Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)

Measured Values
    Atropine-Moderate Amblyopia     Atropine Plus Plano-Moderate Amblyopia     Atropine-Severe Amblyopia     Atropine Plus Plano-Severe Amblyopia  
Number of Participants Analyzed  
[units: participants]
 		  84     88     24     31  
Distribution of Change in Visual Acuity in the Amblyopic Eye  
[units: Participants]
 		       
-3 (worse)     0     1     0     0  
-2     0     0     0     1  
-1     2     2     0     1  
0     4     5     2     2  
+1     18     11     2     3  
+2     18     19     3     1  
+3     22     18     3     2  
+4     17     18     4     3  
>= +5 (better)     3     14     3     3  


Statistical Analysis 1 for Distribution of Change in Visual Acuity in the Amblyopic Eye
Groups [1] Atropine-Moderate Amblyopia vs. Atropine Plus Plano-Moderate Amblyopia
Method [2] Regression, Logistic
P Value [3] 0.39
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

Null hypothesis: proportion 3 or more lines better at 18wks in atropine group = proportion 3 or more lines better at 18wks in atropine plus plano group

Alternative hypothesis: proportion 3 or more lines better at 18wks in atropine group NOT equal to proportion 3 or more lines better at 18wks in atropine plus plano group
[2] Other relevant information, such as adjustments or degrees of freedom:
  proportion 20/25 as a function of treatment group controlling for baseline acuity
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



5.  Secondary:   Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia   [ Time Frame: 18 weeks ]

Measure Type Secondary
Measure Title Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia
Measure Description 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.
Time Frame 18 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.
Not reported among subjects with severe amblyopia

Reporting Groups
  Description
Atropine-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine Plus Plano-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine-Severe Amblyopia Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
Atropine Plus Plano-Severe Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)

Measured Values
    Atropine-Moderate Amblyopia     Atropine Plus Plano-Moderate Amblyopia     Atropine-Severe Amblyopia     Atropine Plus Plano-Severe Amblyopia  
Number of Participants Analyzed  
[units: participants]
 		  84     88     0     0  
Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia  
[units: Participants]
 		       
Failed black & white shape identification pretest     3     4          
>800 arcsec (worst)     40     41          
800 arcsec     7     10          
400 arcsec     11     12          
200 arcsec     10     6          
100 arcsec     4     10          
60 arcsec     5     1          
40 arcsec (best)     2     1          
Not done     2     3          


Statistical Analysis 1 for Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia
Groups [1] Atropine-Moderate Amblyopia vs. Atropine Plus Plano-Moderate Amblyopia
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.39
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All patients without respect to cause of amblyopia.
[2] Other relevant information, such as adjustments or degrees of freedom:
  Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



6.  Secondary:   Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only   [ Time Frame: 18 weeks ]

Measure Type Secondary
Measure Title Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only
Measure Description 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.
Time Frame 18 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.
Not reported among subjects with severe amblyopia

Reporting Groups
  Description
Atropine-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine Plus Plano-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine-Severe Amblyopia Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
Atropine Plus Plano-Severe Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)

Measured Values
    Atropine-Moderate Amblyopia     Atropine Plus Plano-Moderate Amblyopia     Atropine-Severe Amblyopia     Atropine Plus Plano-Severe Amblyopia  
Number of Participants Analyzed  
[units: participants]
 		  29     30     0     0  
Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only  
[units: Participants]
 		       
Failed black & white shape identification pretest     0     0          
>800 arcsec (worst)     7     9          
800 arcsec     2     3          
400 arcsec     5     6          
200 arcsec     8     3          
100 arcsec     3     6          
60 arcsec     1     1          
40 arcsec (best)     2     1          
Not done     1     1          


Statistical Analysis 1 for Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only
Groups [1] Atropine-Moderate Amblyopia vs. Atropine Plus Plano-Moderate Amblyopia
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.90
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Among anisometropic patients only
[2] Other relevant information, such as adjustments or degrees of freedom:
  Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



7.  Secondary:   Mean Change in Visual Acuity in the Sound Eye   [ Time Frame: baseline to 18 weeks ]

Measure Type Secondary
Measure Title Mean Change in Visual Acuity in the Sound Eye
Measure Description

Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.

A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.
Time Frame baseline to 18 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
Atropine-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine Plus Plano-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine-Severe Amblyopia Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
Atropine Plus Plano-Severe Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)

Measured Values
    Atropine-Moderate Amblyopia     Atropine Plus Plano-Moderate Amblyopia     Atropine-Severe Amblyopia     Atropine Plus Plano-Severe Amblyopia  
Number of Participants Analyzed  
[units: participants]
 		  84     88     24     31  
Mean Change in Visual Acuity in the Sound Eye  
[units: logMAR units]
Mean ± Standard Deviation 		  0.4  ± 0.9     0.0  ± 1.0     0.10  ± 0.12     0.15  ± 0.15  

No statistical analysis provided for Mean Change in Visual Acuity in the Sound Eye



8.  Secondary:   Distribution of Change in Visual Acuity in the Sound Eye   [ Time Frame: baseline to 18 weeks ]

Measure Type Secondary
Measure Title Distribution of Change in Visual Acuity in the Sound Eye
Measure Description

Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.

A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.
Time Frame baseline to 18 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
Atropine-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine Plus Plano-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine-Severe Amblyopia Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
Atropine Plus Plano-Severe Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)

Measured Values
    Atropine-Moderate Amblyopia     Atropine Plus Plano-Moderate Amblyopia     Atropine-Severe Amblyopia     Atropine Plus Plano-Severe Amblyopia  
Number of Participants Analyzed  
[units: participants]
 		  84     88     24     31  
Distribution of Change in Visual Acuity in the Sound Eye  
[units: Participants]
 		       
-4 (worse)     1     1     0     0  
-3     0     1     0     0  
-2     0     3     1     4  
-1     3     12     0     2  
0     49     50     11     13  
+1     24     17     9     12  
+2     6     4     3     0  
+3 (better)     1     0     0     0  


Statistical Analysis 1 for Distribution of Change in Visual Acuity in the Sound Eye
Groups [1] Atropine-Moderate Amblyopia vs. Atropine Plus Plano-Moderate Amblyopia
Method [2] Fisher Exact
P Value [3] 0.003
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

Null hypothesis: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups;

Alternate: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



9.  Secondary:   Visual Acuity Distribution in the Sound Eye   [ Time Frame: 18 weeks ]

Measure Type Secondary
Measure Title Visual Acuity Distribution in the Sound Eye
Measure Description

Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18 wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.

20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst
Time Frame 18 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
Atropine-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine Plus Plano-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine-Severe Amblyopia Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
Atropine Plus Plano-Severe Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)

Measured Values
    Atropine-Moderate Amblyopia     Atropine Plus Plano-Moderate Amblyopia     Atropine-Severe Amblyopia     Atropine Plus Plano-Severe Amblyopia  
Number of Participants Analyzed  
[units: participants]
 		  84     88     24     31  
Visual Acuity Distribution in the Sound Eye  
[units: Participants]
 		       
20/63 (worse)     1     1     0     1  
20/50     0     3     1     3  
20/40     2     3     1     4  
20/32     10     16     6     7  
20/25     14     22     8     7  
20/20     36     28     6     7  
20/16 (better)     21     15     2     2  

No statistical analysis provided for Visual Acuity Distribution in the Sound Eye




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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
No text entered.  


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: NCT00315302     History of Changes
Other Study ID Numbers: NEI-115, 2U10EY011751
Study First Received: April 14, 2006
Results First Received: August 3, 2009
Last Updated: May 16, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration