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Observational Study of Optical Correction for Strabismic Amblyopia in Children 3 to <7 Years Old (ATS13)

This study has been completed.
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00669539
First received: April 28, 2008
Last updated: July 7, 2016
Last verified: July 2016
Results First Received: April 16, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Amblyopia

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Combined-Mechanism Amblyopia Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
Strabismus-Only Amblyopia Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.

Participant Flow:   Overall Study
    Combined-Mechanism Amblyopia   Strabismus-Only Amblyopia
STARTED   94   52 
COMPLETED   86 [1]   43 [1] 
NOT COMPLETED   8   9 
[1] Completed defined as completing 18 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.
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Reporting Groups
  Description
Combined-Mechanism Amblyopia Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
Strabismus-Only Amblyopia Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
Total Total of all reporting groups

Baseline Measures
   Combined-Mechanism Amblyopia   Strabismus-Only Amblyopia   Total 
Overall Participants Analyzed 
[Units: Participants]
 94   52   146 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 5.1  (1.1)   4.7  (1.0)   4.9  (1.1) 
[1] Age at enrollment in years
Age, Customized [1] 
[Units: Participants]
     
3 to <4 years   14   16   30 
4 to <5 years   35   16   51 
5 to <6 years   19   15   34 
6 to <7 years   26   5   31 
[1] Age at enrollment in years
Gender 
[Units: Participants]
     
Female   46   23   69 
Male   48   29   77 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   3   0   3 
Black/Aftican American   4   7   11 
Hispanic   4   7   11 
White   82   37   119 
More than one race   0   1   1 
Unknown/not reported   1   0   1 
Distance Visual Acuity Amblyopic Eye [1] 
[Units: logMAR]
Mean (Standard Deviation)
 0.64  (0.24)   0.65  (0.26)   0.64  (0.24) 
[1] Visual acuity was measured in the amblyopic eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 (best) to 20/800 (worst). 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] 
[Units: logMAR]
Mean (Standard Deviation)
 0.09  (0.12)   0.16  (0.11)   0.12  (0.12) 
[1] Visual acuity was measured in the fellow eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 (best) to 20/800 (worst). Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).
Interocular Difference in Distance Visual Acuity [1] 
[Units: logMAR lines]
Mean (Standard Deviation)
 5.4  (2.4)   4.9  (2.2)   5.2  (2.3) 
[1] The difference between eyes in logMAR visual acuity was calculated. Larger positive values of the difference indicate better visual acuity in the fellow eye, larger negative values indicate better visual acuity in the amblyopic eye, and small values indicate similar visual acuities between the eyes.
Spherical Equivalent Refractive Error in Amblyopic Eye [1] 
[Units: Participants]
     
0 to <+1.00 diopters (better)   1   1   2 
+1.00 to <+2.00 diopters   8   3   11 
+2.00 to <+3.00 diopters   5   17   22 
+3.00 to <+4.00 diopters   17   10   27 
>=+4.00 diopters (worse)   63   21   84 
[1] Spherical equivalent in diopters defined from cycloplegic refraction as sphere plus half the cylinder value in the amblyopic eye. Larger values indicate more refractive error; larger spherical equivalent values are worse than smaller values.
Spherical Equivalent Refractive Error in Amblyopic Eye [1] 
[Units: Diopters]
Mean (Standard Deviation)
 4.65  (1.79)   3.69  (1.74)   4.31  (1.83) 
[1] Spherical equivalent in diopters defined from cycloplegic refraction as sphere plus half the cylinder value in the amblyoic eye. Larger values indicate more refractive error; larger spherical equivalent values are worse than smaller values.
Spherical Equivalent Refractive Error in Fellow Eye [1] 
[Units: Participants]
     
0 to <+1.00 diopters (better)   11   1   12 
+1.00 to <+2.00 diopters   24   5   29 
+2.00 to <+3.00 diopters   32   17   49 
+3.00 to <+4.00 diopters   9   12   21 
>=+4.00 diopters (worse)   18   17   35 
[1] Spherical equivalent in diopters defined from cycloplegic refraction as sphere plus half the cylinder value in the fellow eye. Larger values indicate more refractive error; larger spherical equivalent values are worse than smaller values.
Spherical Equivalent Refractive Error in Fellow Eye [1] 
[Units: Diopters]
Mean (Standard Deviation)
 2.61  (1.60)   3.44  (1.62)   2.90  (1.65) 
[1] Spherical equivalent in diopters defined from cycloplegic refraction as sphere plus half the cylinder value in the fellow eye. Larger values indicate more refractive error; larger spherical equivalent values are worse than smaller values.
Ocular Alignment [1] 
[Units: Participants]
     
0 prism diopters (better)   23   14   37 
1-8 prism diopters   48   15   63 
>8 prism diopters (worse)   23   23   46 
[1] Minimum ocular alignment in prism diopters at distance or near defined from the simultaneous prism and cover test. Lower values of ocular alignment are better than higher values.
Ocular Alignment [1] 
[Units: Prism diopters]
Mean (Standard Deviation)
 5.7  (7.0)   11.1  (14.5)   7.6  (10.6) 
[1] Minimum ocular alignment in prism diopters at distance or near defined from the simultaneous prism and cover test. Lower values of ocular alignment are better than higher values.


  Outcome Measures

1.  Primary:   Mean Amblyopic Eye Visual Acuity Improvement With Spectacles   [ Time Frame: Enrollment to 18 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, MSPH
Organization: Jaeb Center for Health Research
phone: 813-875-8690
e-mail: pedig@jaeb.org


Publications of Results:

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00669539     History of Changes
Other Study ID Numbers: NEI-139
2U10EY011751 ( U.S. NIH Grant/Contract )
Study First Received: April 28, 2008
Results First Received: April 16, 2012
Last Updated: July 7, 2016