Determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome).
Understanding the effectiveness of intensive patching has important implications for managing children with IXT. If full-time patching is associated with improvement in distance control vs an observation group, then future studies can be conducted to evaluate different durations of full-time patching treatment, whether the effect is maintained off-treatment, and how full-time patching compares to other treatment strategies. The purpose of this study is to determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
73
adhesive patch to cover eye
Number of Participants With a Change in Mean Distance Control Scores at 3 Months
To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Time frame: 3 months
Primary Outcome Measure Stratified by Sex
NIH-required analysis. Primary outcome measure (stratified by sex): To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Time frame: 3 Months
Primary Outcome Measure Stratified by Race
NIH-required analysis. Primary outcome measure (stratified by race): To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
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UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama, United States
Arkansas Childrens
Little Rock, Arkansas, United States
Univ. of California- Berkeley
Berkeley, California, United States
Southern California College of Optometry
Fullerton, California, United States
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine, California, United States
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, United States
Stanford University
Palo Alto, California, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Progressive Eye Care
Lisle, Illinois, United States
Indiana School of Optometry
Bloomington, Indiana, United States
...and 15 more locations
Time frame: 3 months
Primary Outcome Measure Stratified by Ethnicity
NIH-required analysis. Primary outcome measure (stratified by ethnicity): To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Time frame: 3 months
Primary Outcome: Mean Change in Distance Control Score at 3 Months
To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Time frame: 3 months