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Combined Patching-Atropine for Residual Amblyopia (ATS11)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00506675
Recruitment Status : Terminated (Poor enrollment and infeasibility of ever reaching the necessary sample size)
First Posted : July 25, 2007
Results First Posted : March 23, 2011
Last Update Posted : July 13, 2016
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Ray Kraker, Jaeb Center for Health Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Amblyopia
Interventions Device: Patching
Drug: Atropine
Enrollment 55
Recruitment Details Between October 2007 and March 2009, 27 subjects were randomized to the intensive group and 28 randomized to the weaning group.
Pre-assignment Details Eligible subjects were aged 3-<10 with strabismic and/or anisometropic amblyopia, best-corrected amblyopic eye acuity of 20/32 to 20/63, interocular acuity difference greater than or equal to 2 lines, and no improvement in amblyopic eye acuity between 2 consecutive visits at least 6 weeks apart.
Arm/Group Title Intensive Weaning
Hide Arm/Group Description 6 hours daily patching combined with daily atropine For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
Period Title: Overall Study
Started 27 28
Completed 27 28
Not Completed 0 0
Arm/Group Title Intensive Weaning Total
Hide Arm/Group Description 6 hours daily patching combined with daily atropine For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed. Total of all reporting groups
Overall Number of Baseline Participants 27 28 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 28 participants 55 participants
6.9  (1.1) 6.9  (1.3) 6.9  (1.2)
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
3 to < 7 years 15 13 28
7 to < 10 years 12 15 27
[1]
Measure Description: Age at Enrollment in Years
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
Female
14
  51.9%
11
  39.3%
25
  45.5%
Male
13
  48.1%
17
  60.7%
30
  54.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
White 18 22 40
African American 0 0 0
Hispanic or Latino 7 4 11
Asian 0 1 1
More than one race 2 1 3
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 28 participants 55 participants
27 28 55
Cause of Amblyopia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
Strabismus 10 16 26
Anisometropia 6 3 9
Strabismus and Anisometropia 11 9 20
Current Treatment for Amblyopia at Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
Patching 18 21 39
Atropine 9 7 16
Distance Visual Acuity in Amblyopic Eye   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
20/63 (0.54 to 0.46 logMAR) 3 2 5
20/50 (0.44 to 0.36 logMAR) 13 12 25
20/40 (0.34 to 0.26 logMAR) 7 10 17
20/32 (0.24 to 0.16 logMAR) 4 4 8
[1]
Measure Description: Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).
Distance Visual Acuity in Fellow Eye   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
20/32 (0.24 to 0.16 logMAR) 2 4 6
20/25 (0.14 to 0.06 logMAR) 10 7 17
20/20 (0.04 to -0.04 logMAR) 8 11 19
20/16 (-0.06 to -0.14 logMAR) 7 6 13
[1]
Measure Description: Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).
Refractive Error in Amblyopic Eye (spherical equivalent/diopters)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
< 0.00D 0 3 3
0 to < +1.00 D 1 0 1
+1.00 to < +2.00D 3 1 4
+2.00 to < +3.00D 0 2 2
+3.00 to < +4.00D 1 5 6
greater than or equal to +4.00D 22 17 39
[1]
Measure Description: Spherical equivalent in diopters defined from cycloplegic refraction as sphere plus half the cylinder value
Refractive Error in Fellow Eye   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
< 0.00D 1 0 1
0 to < +1.00D 2 2 4
+1.00 to < +2.00D 5 5 10
+2.00 to < +3.00D 4 4 8
+3.00 to < +4.00D 6 7 13
greater than or equal to +4.00D 9 10 19
[1]
Measure Description: Spherical equivalent in diopters defined from cycloplegic refraction as sphere plus half the cylinder value
Mean (SD) Intereye Acuity Difference   [1] 
Mean (Standard Deviation)
Unit of measure:  logMAR
Number Analyzed 27 participants 28 participants 55 participants
0.33  (0.11) 0.31  (0.10) 0.32  (0.11)
[1]
Measure Description: The difference between eyes in logMAR acuity was calculated with positive values indicating sound eye better. One letter = .02 logMAR, .1 logMAR = 5 letters or one line of visual acuity.
Mean (SD) Distance Visual Acuity in Fellow Eye   [1] 
Mean (Standard Deviation)
Unit of measure:  logMAR
Number Analyzed 27 participants 28 participants 55 participants
0.02  (0.09) 0.03  (0.10) 0.03  (0.09)
[1]
Measure Description: Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).
Mean (SD) Spherical Equivalent Refractive Error in Amblyopic Eye   [1] 
Mean (Standard Deviation)
Unit of measure:  Diopters
Number Analyzed 27 participants 28 participants 55 participants
5.39  (2.33) 4.24  (2.15) 4.81  (2.29)
[1]
Measure Description: Spherical equivalent in diopters defined from cycloplegic refraction as sphere plus half the cylinder value
Mean (SD) Spherical Equivalent Refractive Error in Fellow Eye   [1] 
Mean (Standard Deviation)
Unit of measure:  Diopters
Number Analyzed 27 participants 28 participants 55 participants
3.46  (2.38) 3.29  (1.90) 3.37  (2.13)
[1]
Measure Description: Spherical equivalent in diopters defined from cycloplegic refraction as sphere plus half the cylinder value
Mean (SD) Distance Visual Acuity in Amblyopic Eye   [1] 
Mean (Standard Deviation)
Unit of measure:  logMAR
Number Analyzed 27 participants 28 participants 55 participants
0.35  (0.09) 0.34  (0.08) 0.35  (0.09)
[1]
Measure Description: Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).
1.Primary Outcome
Title Distribution of Amblyopic Eye Visual Acuity at 10 Weeks
Hide Description Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).
Time Frame 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Weaning
Hide Arm/Group Description:
6 hours daily patching combined with daily atropine
For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
Overall Number of Participants Analyzed 27 28
Measure Type: Number
Unit of Measure: participants
20/125 (0.84 to 0.76 logMAR) 0 1
20/100 (0.74 to 0.66 logMAR) 0 0
20/80 (0.64 to 0.56 logMAR) 1 1
20/63 (0.54 to 0.46 logMAR) 1 4
20/50 (0.44 to 0.36 logMAR) 4 0
20/40 (0.34 to 0.26 logMAR) 13 9
20/32 (0.24 to 0.16 logMAR) 7 7
20/25 (0.14 to 0.06 logMAR) 1 3
20/20 (0.04 to -0.04 logMAR) 0 2
20/16 (-0.16 to -0.24 logMAR) 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive, Weaning
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Mean (SD) Distribution of Visual Acuity at 10 Weeks
Hide Description Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).
Time Frame 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Weaning
Hide Arm/Group Description:
6 hours daily patching combined with daily atropine
For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
Overall Number of Participants Analyzed 27 28
Mean (Standard Deviation)
Unit of Measure: logMAR
0.30  (0.10) 0.29  (0.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive, Weaning
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks
Hide Description Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.
Time Frame baseline to 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Weaning
Hide Arm/Group Description:
6 hours daily patching combined with daily atropine
For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
Overall Number of Participants Analyzed 27 28
Measure Type: Number
Unit of Measure: Participants
greater than or equal to 3 lines 0 1
2 to < 3 lines worse 1 0
1 to < 2 lines worse 2 4
Within 1 logMAR line 12 8
1 to < 2 lines better 9 8
2 to < 3 lines better 3 5
greater than or equal to 3 lines better 0 1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive, Weaning
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Primary Outcome
Title Mean (SD) Change in Visual Acuity in the Amblyopic Eye at the 10 Week Primary Outcome Exam
Hide Description Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.
Time Frame baseline to 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Weaning
Hide Arm/Group Description:
6 hours daily patching combined with daily atropine
For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
Overall Number of Participants Analyzed 27 28
Mean (Standard Deviation)
Unit of Measure: logMAR
0.056  (0.096) 0.053  (0.150)
Time Frame 10 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intensive Weaning
Hide Arm/Group Description 6 hours daily patching combined with daily atropine For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
All-Cause Mortality
Intensive Weaning
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Intensive Weaning
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/28 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intensive Weaning
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/27 (22.22%)      0/28 (0.00%)    
General disorders     
Light sensitivity   6/27 (22.22%)  6 0/28 (0.00%)  0
Indicates events were collected by systematic assessment
This trial was stopped after 18 months due to inadequate recruitment.
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
Layout table for Results Point of Contact information
Name/Title: Raymond Kraker, MSPH
Organization: Jaeb Center for Health Research
Phone: 813-975-8690
EMail: pedig@jaeb.org
Layout table for additonal information
Responsible Party: Ray Kraker, Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00506675    
Other Study ID Numbers: NEI-135
2U10EY011751 ( U.S. NIH Grant/Contract )
First Submitted: July 20, 2007
First Posted: July 25, 2007
Results First Submitted: September 14, 2010
Results First Posted: March 23, 2011
Last Update Posted: July 13, 2016