Trial Outcomes & Findings for Full-Time Occlusion Therapy for Intermittent Exotropia in Children (NCT NCT05462821)
NCT ID: NCT05462821
Last Updated: 2026-08-03
Results Overview
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).
COMPLETED
PHASE3
73 participants
3 months
2026-08-03
Participant Flow
Participant milestones
| Measure |
Observation Group
Participants randomized to observation alone will not be allowed to receive any other treatment for IXT, except refractive correction, for 3 months.
|
Full Time Patching
Participants randomized to the full-time patching group will patch full-time (all waking hours) for 3 months up until the day before the 3-month primary outcome visit. Daily alternate patching will be prescribed (right eye on even days, left eye on odd days). No other treatment for IXT will be used, except for refractive correction.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
36
|
|
Overall Study
COMPLETED
|
35
|
33
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Full-Time Occlusion Therapy for Intermittent Exotropia in Children
Baseline characteristics by cohort
| Measure |
Observation Group
n=37 Participants
Participants randomized to observation alone will not be allowed to receive any other treatment for IXT, except refractive correction, for 3 months.
|
Full Time Patching
n=36 Participants
Participants randomized to the full-time patching group will patch full-time (all waking hours) for 3 months up until the day before the 3-month primary outcome visit. Daily alternate patching will be prescribed (right eye on even days, left eye on odd days). No other treatment for IXT will be used, except for refractive correction.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
3 years old
|
5 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Age, Customized
4 years old
|
8 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Age, Customized
5 years old
|
8 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Age, Customized
6 years old
|
6 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Age, Customized
7 years old
|
8 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Age, Customized
8 years old
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=20 Participants
|
24 Participants
n=20 Participants
|
45 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
28 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=20 Participants
|
25 Participants
n=20 Participants
|
51 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
36 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Prior Non-Surgical Treatments for IXT
Overminus > 1 year prior to enrollment
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Prior Non-Surgical Treatments for IXT
Patching > 1 year prior to enrollment
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Prior Non-Surgical Treatments for IXT
Prism > 1 year prior to enrollment
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Prior Non-Surgical Treatments for IXT
Pencil Push-Ups within 1 year prior to enrollment (patient ineligible)
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Prior Non-Surgical Treatments for IXT
None
|
33 Participants
n=20 Participants
|
34 Participants
n=20 Participants
|
67 Participants
n=40 Participants
|
|
Neurological Anomaly That Could Affect Ocular Motility?
Yes (patient ineligible)
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Neurological Anomaly That Could Affect Ocular Motility?
No
|
36 Participants
n=20 Participants
|
36 Participants
n=20 Participants
|
72 Participants
n=40 Participants
|
|
Spectacle Status
Not wearing spectacles
|
26 Participants
n=20 Participants
|
26 Participants
n=20 Participants
|
52 Participants
n=40 Participants
|
|
Spectacle Status
Wearing spectacles at least two weeks
|
11 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Stereoacuity at near, arcseconds (log10 arcseconds)
40 (1.60)
|
5 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Stereoacuity at near, arcseconds (log10 arcseconds)
60 (1.78)
|
12 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Stereoacuity at near, arcseconds (log10 arcseconds)
100 (2.00)
|
6 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Stereoacuity at near, arcseconds (log10 arcseconds)
200 (2.30)
|
5 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Stereoacuity at near, arcseconds (log10 arcseconds)
400 (2.60)
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Stereoacuity at near, arcseconds (log10 arcseconds)
800 (2.90)
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Stereoacuity at near, arcseconds (log10 arcseconds)
Nil (3.20)
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Stereoacuity at near, arcseconds (log10 arcseconds)
Unable to Complete pretest
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Average OD/OS Visual Acuity Snellen Equivalent (logMAR)
20/25 (0.1)
|
12 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Average OD/OS Visual Acuity Snellen Equivalent (logMAR)
20/32 (0.2)
|
3 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Participant Baseline Suppression Scores
Negligible (0)
|
9 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Participant Baseline Suppression Scores
Mild (1)
|
5 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Participant Baseline Suppression Scores
Moderate (2)
|
7 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
Participant Baseline Suppression Scores
Dense (3)
|
11 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
|
Participant Baseline Suppression Scores
Missing (children were unable to understand the test and/or gave unreliable responses)
|
5 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Interocular Difference in Visual Acuity (logMAR lines)
Within one line (0 to <1)
|
24 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
45 Participants
n=40 Participants
|
|
Interocular Difference in Visual Acuity (logMAR lines)
One line (1 to <2)
|
10 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Interocular Difference in Visual Acuity (logMAR lines)
Two lines (=2)
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Average OD/OS Visual Acuity Snellen Equivalent (logMAR)
20/12 (-0.2)
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Average OD/OS Visual Acuity Snellen Equivalent (logMAR)
20/16 (-0.1)
|
8 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Average OD/OS Visual Acuity Snellen Equivalent (logMAR)
20/20 (0.0)
|
10 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Average OD/OS Visual Acuity Snellen Equivalent (logMAR)
20/40 (0.3)
|
2 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Average OD/OS Visual Acuity Snellen Equivalent (logMAR)
20/50 (0.4)
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Average OD/OS Spherical Equivalent Refractive Error, D
-6.00 to <-0.50 D
|
4 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Average OD/OS Spherical Equivalent Refractive Error, D
-0.50 to <0.50 D
|
13 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
26 Participants
n=40 Participants
|
|
Average OD/OS Spherical Equivalent Refractive Error, D
0.50 to <2.00D
|
20 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
38 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 3 monthsTo 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).
Outcome measures
| Measure |
Observation Group
n=35 Participants
Participants randomized to observation alone will not be allowed to receive any other treatment for IXT, except refractive correction, for 3 months.
|
Full Time Patching
n=33 Participants
Participants randomized to the full-time patching group will patch full-time (all waking hours) for 3 months up until the day before the 3-month primary outcome visit. Daily alternate patching will be prescribed (right eye on even days, left eye on odd days). No other treatment for IXT will be used, except for refractive correction.
Eye Patch: adhesive patch to cover eye
|
|---|---|---|
|
Number of Participants With a Change in Mean Distance Control Scores at 3 Months
2 to <3
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Change in Mean Distance Control Scores at 3 Months
1 to <2
|
4 Participants
|
4 Participants
|
|
Number of Participants With a Change in Mean Distance Control Scores at 3 Months
0 to <1
|
13 Participants
|
8 Participants
|
|
Number of Participants With a Change in Mean Distance Control Scores at 3 Months
-1 to <0
|
7 Participants
|
3 Participants
|
|
Number of Participants With a Change in Mean Distance Control Scores at 3 Months
-2 to <-1
|
8 Participants
|
9 Participants
|
|
Number of Participants With a Change in Mean Distance Control Scores at 3 Months
-3 to <-2
|
1 Participants
|
7 Participants
|
|
Number of Participants With a Change in Mean Distance Control Scores at 3 Months
-4 to <-3
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 3 MonthsPopulation: Data were 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).
Outcome measures
| Measure |
Observation Group
n=35 Participants
Participants randomized to observation alone will not be allowed to receive any other treatment for IXT, except refractive correction, for 3 months.
|
Full Time Patching
n=33 Participants
Participants randomized to the full-time patching group will patch full-time (all waking hours) for 3 months up until the day before the 3-month primary outcome visit. Daily alternate patching will be prescribed (right eye on even days, left eye on odd days). No other treatment for IXT will be used, except for refractive correction.
Eye Patch: adhesive patch to cover eye
|
|---|---|---|
|
Primary Outcome Measure Stratified by Sex
Female
|
-0.17 points
Standard Deviation 1.05
|
-0.98 points
Standard Deviation 1.32
|
|
Primary Outcome Measure Stratified by Sex
Male
|
-0.31 points
Standard Deviation 1.11
|
-0.64 points
Standard Deviation 1.30
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Data were 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).
Outcome measures
| Measure |
Observation Group
n=35 Participants
Participants randomized to observation alone will not be allowed to receive any other treatment for IXT, except refractive correction, for 3 months.
|
Full Time Patching
n=33 Participants
Participants randomized to the full-time patching group will patch full-time (all waking hours) for 3 months up until the day before the 3-month primary outcome visit. Daily alternate patching will be prescribed (right eye on even days, left eye on odd days). No other treatment for IXT will be used, except for refractive correction.
Eye Patch: adhesive patch to cover eye
|
|---|---|---|
|
Primary Outcome Measure Stratified by Race
American Indian/Alaskan Native
|
-0.17 points
Standard Deviation 0.24
|
NA points
Results for this subgroup are omitted because the standard deviation cannot be calculated (N=1).
|
|
Primary Outcome Measure Stratified by Race
Asian
|
0.22 points
Standard Deviation 0.84
|
-1.92 points
Standard Deviation 0.83
|
|
Primary Outcome Measure Stratified by Race
Black/African American
|
0.21 points
Standard Deviation 1.21
|
-0.67 points
Standard Deviation 1.05
|
|
Primary Outcome Measure Stratified by Race
More than one race
|
0.67 points
Standard Deviation 0.94
|
0.11 points
Standard Deviation 1.26
|
|
Primary Outcome Measure Stratified by Race
Unknown/not reported
|
-1.33 points
Standard Deviation 0.88
|
-1.25 points
Standard Deviation 1.13
|
|
Primary Outcome Measure Stratified by Race
White
|
-0.43 points
Standard Deviation 1.00
|
-0.71 points
Standard Deviation 1.43
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Data were 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).
Outcome measures
| Measure |
Observation Group
n=35 Participants
Participants randomized to observation alone will not be allowed to receive any other treatment for IXT, except refractive correction, for 3 months.
|
Full Time Patching
n=33 Participants
Participants randomized to the full-time patching group will patch full-time (all waking hours) for 3 months up until the day before the 3-month primary outcome visit. Daily alternate patching will be prescribed (right eye on even days, left eye on odd days). No other treatment for IXT will be used, except for refractive correction.
Eye Patch: adhesive patch to cover eye
|
|---|---|---|
|
Primary Outcome Measure Stratified by Ethnicity
Hispanic or Latino
|
-0.07 points
Standard Deviation 0.54
|
-0.43 points
Standard Deviation 1.32
|
|
Primary Outcome Measure Stratified by Ethnicity
Not Hispanic or Latino
|
-0.29 points
Standard Deviation 1.21
|
-1.06 points
Standard Deviation 1.21
|
PRIMARY outcome
Timeframe: 3 monthsTo 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).
Outcome measures
| Measure |
Observation Group
n=35 Participants
Participants randomized to observation alone will not be allowed to receive any other treatment for IXT, except refractive correction, for 3 months.
|
Full Time Patching
n=33 Participants
Participants randomized to the full-time patching group will patch full-time (all waking hours) for 3 months up until the day before the 3-month primary outcome visit. Daily alternate patching will be prescribed (right eye on even days, left eye on odd days). No other treatment for IXT will be used, except for refractive correction.
Eye Patch: adhesive patch to cover eye
|
|---|---|---|
|
Primary Outcome: Mean Change in Distance Control Score at 3 Months
|
3.4 points
Standard Deviation 1.3
|
2.7 points
Standard Deviation 1.8
|
Adverse Events
Observation Group
Full Time Patching
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Victoria Woodard, Publications Manager
Jaeb Center for Health Research - Pediatric Eye Disease Investigator Group
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place