Trial Outcomes & Findings for Full-Time Occlusion Therapy for Intermittent Exotropia in Children (NCT 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

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

Baseline characteristics by cohort
Measure	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.	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.
Age, Customized 3 years old	10 Participants n=9 Participants	5 Participants n=9 Participants	5 Participants n=6 Participants
Age, Customized 4 years old	20 Participants n=9 Participants	8 Participants n=9 Participants	12 Participants n=6 Participants
Age, Customized 5 years old	13 Participants n=9 Participants	8 Participants n=9 Participants	5 Participants n=6 Participants
Age, Customized 6 years old	11 Participants n=9 Participants	6 Participants n=9 Participants	5 Participants n=6 Participants
Age, Customized 7 years old	14 Participants n=9 Participants	8 Participants n=9 Participants	6 Participants n=6 Participants
Age, Customized 8 years old	5 Participants n=9 Participants	2 Participants n=9 Participants	3 Participants n=6 Participants
Sex: Female, Male Female	45 Participants n=9 Participants	21 Participants n=9 Participants	24 Participants n=6 Participants
Sex: Female, Male Male	28 Participants n=9 Participants	16 Participants n=9 Participants	12 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=9 Participants	11 Participants n=9 Participants	11 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=9 Participants	26 Participants n=9 Participants	25 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=9 Participants	2 Participants n=9 Participants	1 Participants n=6 Participants
Race (NIH/OMB) Asian	7 Participants n=9 Participants	3 Participants n=9 Participants	4 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	14 Participants n=9 Participants	8 Participants n=9 Participants	6 Participants n=6 Participants
Race (NIH/OMB) White	36 Participants n=9 Participants	19 Participants n=9 Participants	17 Participants n=6 Participants
Race (NIH/OMB) More than one race	5 Participants n=9 Participants	2 Participants n=9 Participants	3 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=9 Participants	3 Participants n=9 Participants	5 Participants n=6 Participants
Prior Non-Surgical Treatments for IXT Overminus > 1 year prior to enrollment	2 Participants n=9 Participants	1 Participants n=9 Participants	1 Participants n=6 Participants
Prior Non-Surgical Treatments for IXT Patching > 1 year prior to enrollment	2 Participants n=9 Participants	1 Participants n=9 Participants	1 Participants n=6 Participants
Prior Non-Surgical Treatments for IXT Prism > 1 year prior to enrollment	1 Participants n=9 Participants	1 Participants n=9 Participants	0 Participants n=6 Participants
Prior Non-Surgical Treatments for IXT Pencil Push-Ups within 1 year prior to enrollment (patient ineligible)	1 Participants n=9 Participants	1 Participants n=9 Participants	0 Participants n=6 Participants
Prior Non-Surgical Treatments for IXT None	67 Participants n=9 Participants	33 Participants n=9 Participants	34 Participants n=6 Participants
Neurological Anomaly That Could Affect Ocular Motility? Yes (patient ineligible)	1 Participants n=9 Participants	1 Participants n=9 Participants	0 Participants n=6 Participants
Neurological Anomaly That Could Affect Ocular Motility? No	72 Participants n=9 Participants	36 Participants n=9 Participants	36 Participants n=6 Participants
Spectacle Status Not wearing spectacles	52 Participants n=9 Participants	26 Participants n=9 Participants	26 Participants n=6 Participants
Spectacle Status Wearing spectacles at least two weeks	21 Participants n=9 Participants	11 Participants n=9 Participants	10 Participants n=6 Participants
Stereoacuity at near, arcseconds (log10 arcseconds) 40 (1.60)	13 Participants n=9 Participants	5 Participants n=9 Participants	8 Participants n=6 Participants
Stereoacuity at near, arcseconds (log10 arcseconds) 60 (1.78)	21 Participants n=9 Participants	12 Participants n=9 Participants	9 Participants n=6 Participants
Stereoacuity at near, arcseconds (log10 arcseconds) 100 (2.00)	12 Participants n=9 Participants	6 Participants n=9 Participants	6 Participants n=6 Participants
Stereoacuity at near, arcseconds (log10 arcseconds) 200 (2.30)	8 Participants n=9 Participants	5 Participants n=9 Participants	3 Participants n=6 Participants
Stereoacuity at near, arcseconds (log10 arcseconds) 400 (2.60)	7 Participants n=9 Participants	4 Participants n=9 Participants	3 Participants n=6 Participants
Stereoacuity at near, arcseconds (log10 arcseconds) 800 (2.90)	4 Participants n=9 Participants	1 Participants n=9 Participants	3 Participants n=6 Participants
Stereoacuity at near, arcseconds (log10 arcseconds) Nil (3.20)	4 Participants n=9 Participants	2 Participants n=9 Participants	2 Participants n=6 Participants
Stereoacuity at near, arcseconds (log10 arcseconds) Unable to Complete pretest	4 Participants n=9 Participants	2 Participants n=9 Participants	2 Participants n=6 Participants
Participant Baseline Suppression Scores Negligible (0)	13 Participants n=9 Participants	9 Participants n=9 Participants	4 Participants n=6 Participants
Participant Baseline Suppression Scores Mild (1)	10 Participants n=9 Participants	5 Participants n=9 Participants	5 Participants n=6 Participants
Participant Baseline Suppression Scores Moderate (2)	16 Participants n=9 Participants	7 Participants n=9 Participants	9 Participants n=6 Participants
Average OD/OS Visual Acuity Snellen Equivalent (logMAR) 20/20 (0.0)	18 Participants n=9 Participants	10 Participants n=9 Participants	8 Participants n=6 Participants
Average OD/OS Visual Acuity Snellen Equivalent (logMAR) 20/25 (0.1)	20 Participants n=9 Participants	12 Participants n=9 Participants	8 Participants n=6 Participants
Participant Baseline Suppression Scores Dense (3)	23 Participants n=9 Participants	11 Participants n=9 Participants	12 Participants n=6 Participants
Participant Baseline Suppression Scores Missing (children were unable to understand the test and/or gave unreliable responses)	11 Participants n=9 Participants	5 Participants n=9 Participants	6 Participants n=6 Participants
Interocular Difference in Visual Acuity (logMAR lines) Within one line (0 to <1)	45 Participants n=9 Participants	24 Participants n=9 Participants	21 Participants n=6 Participants
Interocular Difference in Visual Acuity (logMAR lines) One line (1 to <2)	21 Participants n=9 Participants	10 Participants n=9 Participants	11 Participants n=6 Participants
Interocular Difference in Visual Acuity (logMAR lines) Two lines (=2)	7 Participants n=9 Participants	3 Participants n=9 Participants	4 Participants n=6 Participants
Average OD/OS Visual Acuity Snellen Equivalent (logMAR) 20/12 (-0.2)	2 Participants n=9 Participants	1 Participants n=9 Participants	1 Participants n=6 Participants
Average OD/OS Visual Acuity Snellen Equivalent (logMAR) 20/16 (-0.1)	18 Participants n=9 Participants	8 Participants n=9 Participants	10 Participants n=6 Participants
Average OD/OS Visual Acuity Snellen Equivalent (logMAR) 20/32 (0.2)	8 Participants n=9 Participants	3 Participants n=9 Participants	5 Participants n=6 Participants
Average OD/OS Visual Acuity Snellen Equivalent (logMAR) 20/40 (0.3)	6 Participants n=9 Participants	2 Participants n=9 Participants	4 Participants n=6 Participants
Average OD/OS Visual Acuity Snellen Equivalent (logMAR) 20/50 (0.4)	1 Participants n=9 Participants	1 Participants n=9 Participants	0 Participants n=6 Participants
Average OD/OS Spherical Equivalent Refractive Error, D -6.00 to <-0.50 D	9 Participants n=9 Participants	4 Participants n=9 Participants	5 Participants n=6 Participants
Average OD/OS Spherical Equivalent Refractive Error, D -0.50 to <0.50 D	26 Participants n=9 Participants	13 Participants n=9 Participants	13 Participants n=6 Participants
Average OD/OS Spherical Equivalent Refractive Error, D 0.50 to <2.00D	38 Participants n=9 Participants	20 Participants n=9 Participants	18 Participants n=6 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

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