Trial Outcomes & Findings for Full-Time Occlusion Therapy for Intermittent Exotropia in Children (NCT NCT05462821)
NCT ID: NCT05462821
Last Updated: 2025-12-02
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
73 participants
Primary outcome timeframe
3 months
Results posted on
2025-12-02
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 |
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
|
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.
|
|---|---|---|---|
|
Prior Non-Surgical Treatments for IXT
Prism > 1 year prior to enrollment
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
1 Participants
n=121 Participants
|
|
Prior Non-Surgical Treatments for IXT
Pencil Push-Ups within 1 year prior to enrollment (patient ineligible)
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
1 Participants
n=121 Participants
|
|
Prior Non-Surgical Treatments for IXT
None
|
34 Participants
n=122 Participants
|
67 Participants
n=243 Participants
|
33 Participants
n=121 Participants
|
|
Age, Customized
3 years old
|
5 Participants
n=122 Participants
|
10 Participants
n=243 Participants
|
5 Participants
n=121 Participants
|
|
Age, Customized
4 years old
|
12 Participants
n=122 Participants
|
20 Participants
n=243 Participants
|
8 Participants
n=121 Participants
|
|
Age, Customized
5 years old
|
5 Participants
n=122 Participants
|
13 Participants
n=243 Participants
|
8 Participants
n=121 Participants
|
|
Age, Customized
6 years old
|
5 Participants
n=122 Participants
|
11 Participants
n=243 Participants
|
6 Participants
n=121 Participants
|
|
Age, Customized
7 years old
|
6 Participants
n=122 Participants
|
14 Participants
n=243 Participants
|
8 Participants
n=121 Participants
|
|
Age, Customized
8 years old
|
3 Participants
n=122 Participants
|
5 Participants
n=243 Participants
|
2 Participants
n=121 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=122 Participants
|
45 Participants
n=243 Participants
|
21 Participants
n=121 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=122 Participants
|
28 Participants
n=243 Participants
|
16 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=122 Participants
|
22 Participants
n=243 Participants
|
11 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=122 Participants
|
51 Participants
n=243 Participants
|
26 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=122 Participants
|
3 Participants
n=243 Participants
|
2 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=122 Participants
|
7 Participants
n=243 Participants
|
3 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=122 Participants
|
14 Participants
n=243 Participants
|
8 Participants
n=121 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=122 Participants
|
36 Participants
n=243 Participants
|
19 Participants
n=121 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=122 Participants
|
5 Participants
n=243 Participants
|
2 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=122 Participants
|
8 Participants
n=243 Participants
|
3 Participants
n=121 Participants
|
|
Prior Non-Surgical Treatments for IXT
Overminus > 1 year prior to enrollment
|
1 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
1 Participants
n=121 Participants
|
|
Prior Non-Surgical Treatments for IXT
Patching > 1 year prior to enrollment
|
1 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
1 Participants
n=121 Participants
|
|
Neurological Anomaly That Could Affect Ocular Motility?
Yes (patient ineligible)
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
1 Participants
n=121 Participants
|
|
Neurological Anomaly That Could Affect Ocular Motility?
No
|
36 Participants
n=122 Participants
|
72 Participants
n=243 Participants
|
36 Participants
n=121 Participants
|
|
Spectacle Status
Not wearing spectacles
|
26 Participants
n=122 Participants
|
52 Participants
n=243 Participants
|
26 Participants
n=121 Participants
|
|
Spectacle Status
Wearing spectacles at least two weeks
|
10 Participants
n=122 Participants
|
21 Participants
n=243 Participants
|
11 Participants
n=121 Participants
|
|
Stereoacuity at near, arcseconds (log10 arcseconds)
40 (1.60)
|
8 Participants
n=122 Participants
|
13 Participants
n=243 Participants
|
5 Participants
n=121 Participants
|
|
Stereoacuity at near, arcseconds (log10 arcseconds)
60 (1.78)
|
9 Participants
n=122 Participants
|
21 Participants
n=243 Participants
|
12 Participants
n=121 Participants
|
|
Stereoacuity at near, arcseconds (log10 arcseconds)
100 (2.00)
|
6 Participants
n=122 Participants
|
12 Participants
n=243 Participants
|
6 Participants
n=121 Participants
|
|
Stereoacuity at near, arcseconds (log10 arcseconds)
200 (2.30)
|
3 Participants
n=122 Participants
|
8 Participants
n=243 Participants
|
5 Participants
n=121 Participants
|
|
Stereoacuity at near, arcseconds (log10 arcseconds)
400 (2.60)
|
3 Participants
n=122 Participants
|
7 Participants
n=243 Participants
|
4 Participants
n=121 Participants
|
|
Stereoacuity at near, arcseconds (log10 arcseconds)
800 (2.90)
|
3 Participants
n=122 Participants
|
4 Participants
n=243 Participants
|
1 Participants
n=121 Participants
|
|
Stereoacuity at near, arcseconds (log10 arcseconds)
Nil (3.20)
|
2 Participants
n=122 Participants
|
4 Participants
n=243 Participants
|
2 Participants
n=121 Participants
|
|
Stereoacuity at near, arcseconds (log10 arcseconds)
Unable to Complete pretest
|
2 Participants
n=122 Participants
|
4 Participants
n=243 Participants
|
2 Participants
n=121 Participants
|
|
Participant Baseline Suppression Scores
Negligible (0)
|
4 Participants
n=122 Participants
|
13 Participants
n=243 Participants
|
9 Participants
n=121 Participants
|
|
Participant Baseline Suppression Scores
Mild (1)
|
5 Participants
n=122 Participants
|
10 Participants
n=243 Participants
|
5 Participants
n=121 Participants
|
|
Participant Baseline Suppression Scores
Moderate (2)
|
9 Participants
n=122 Participants
|
16 Participants
n=243 Participants
|
7 Participants
n=121 Participants
|
|
Participant Baseline Suppression Scores
Dense (3)
|
12 Participants
n=122 Participants
|
23 Participants
n=243 Participants
|
11 Participants
n=121 Participants
|
|
Participant Baseline Suppression Scores
Missing (children were unable to understand the test and/or gave unreliable responses)
|
6 Participants
n=122 Participants
|
11 Participants
n=243 Participants
|
5 Participants
n=121 Participants
|
|
Interocular Difference in Visual Acuity (logMAR lines)
Within one line (0 to <1)
|
21 Participants
n=122 Participants
|
45 Participants
n=243 Participants
|
24 Participants
n=121 Participants
|
|
Interocular Difference in Visual Acuity (logMAR lines)
One line (1 to <2)
|
11 Participants
n=122 Participants
|
21 Participants
n=243 Participants
|
10 Participants
n=121 Participants
|
|
Interocular Difference in Visual Acuity (logMAR lines)
Two lines (=2)
|
4 Participants
n=122 Participants
|
7 Participants
n=243 Participants
|
3 Participants
n=121 Participants
|
|
Average OD/OS Visual Acuity Snellen Equivalent (logMAR)
20/12 (-0.2)
|
1 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
1 Participants
n=121 Participants
|
|
Average OD/OS Visual Acuity Snellen Equivalent (logMAR)
20/16 (-0.1)
|
10 Participants
n=122 Participants
|
18 Participants
n=243 Participants
|
8 Participants
n=121 Participants
|
|
Average OD/OS Visual Acuity Snellen Equivalent (logMAR)
20/20 (0.0)
|
8 Participants
n=122 Participants
|
18 Participants
n=243 Participants
|
10 Participants
n=121 Participants
|
|
Average OD/OS Visual Acuity Snellen Equivalent (logMAR)
20/25 (0.1)
|
8 Participants
n=122 Participants
|
20 Participants
n=243 Participants
|
12 Participants
n=121 Participants
|
|
Average OD/OS Visual Acuity Snellen Equivalent (logMAR)
20/32 (0.2)
|
5 Participants
n=122 Participants
|
8 Participants
n=243 Participants
|
3 Participants
n=121 Participants
|
|
Average OD/OS Visual Acuity Snellen Equivalent (logMAR)
20/40 (0.3)
|
4 Participants
n=122 Participants
|
6 Participants
n=243 Participants
|
2 Participants
n=121 Participants
|
|
Average OD/OS Visual Acuity Snellen Equivalent (logMAR)
20/50 (0.4)
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
1 Participants
n=121 Participants
|
|
Average OD/OS Spherical Equivalent Refractive Error, D
-6.00 to <-0.50 D
|
5 Participants
n=122 Participants
|
9 Participants
n=243 Participants
|
4 Participants
n=121 Participants
|
|
Average OD/OS Spherical Equivalent Refractive Error, D
-0.50 to <0.50 D
|
13 Participants
n=122 Participants
|
26 Participants
n=243 Participants
|
13 Participants
n=121 Participants
|
|
Average OD/OS Spherical Equivalent Refractive Error, D
0.50 to <2.00D
|
18 Participants
n=122 Participants
|
38 Participants
n=243 Participants
|
20 Participants
n=121 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
|
Adverse Events
Observation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Full Time Patching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
Phone: 813-975-8690
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place