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Behavioural Intervention

Eye Patching for Intermittent Exotropia (IXT7 Trial)

N/A
Recruiting
Research Sponsored by Jaeb Center for Health Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Summary

This trial looks at whether covering one eye all the time is better than just monitoring it for improving distance vision in kids after 3 months of treatment.

Who is the study for?
This trial is for children aged 3 to under 9 with intermittent exotropia, a type of eye misalignment. They must have worn corrective glasses if needed, be in good health otherwise, and not planning to move away soon. Kids who've had previous eye surgeries or treatments for this condition, severe developmental delays, or allergies to adhesive patches can't join.Check my eligibility
What is being tested?
The study tests if wearing an eye patch full-time helps improve the control of intermittent exotropia over three months better than just watching the condition without treatment. The effectiveness will be compared after the treatment period.See study design
What are the potential side effects?
While not explicitly stated here, potential side effects from using an eye patch may include skin irritation around the patched area due to adhesive use and discomfort from prolonged occlusion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in mean distance control scores at 3 months

Side effects data

From 2013 Phase 3 trial • 169 Patients • NCT00945100
7%
New ocular deviation or worsening of preexisting deviation by at least 10 pd
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control
Intensified Treatment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Full Time PatchingExperimental Treatment1 Intervention
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.
Group II: Observation GroupActive Control1 Intervention
Participants randomized to observation alone will not be allowed to receive any other treatment for IXT, except refractive correction, for 3 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eye Patch
2009
Completed Phase 3
~1020

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Intermittent Exotropia is commonly treated with methods such as full-time patching, which involves covering the dominant eye to force the use of the non-patched eye. This treatment aims to improve the control of eye alignment by strengthening the weaker eye and enhancing binocular vision. The mechanism of action is based on neuroplasticity, where the brain adapts to the increased use of the non-dominant eye, potentially leading to better eye coordination and reduced outward drifting. This is crucial for patients as it can improve visual function and reduce the frequency of misalignment episodes, thereby enhancing overall quality of life.

Find a Location

Who is running the clinical trial?

Jaeb Center for Health ResearchLead Sponsor
154 Previous Clinical Trials
35,027 Total Patients Enrolled
3 Trials studying Intermittent Exotropia
505 Patients Enrolled for Intermittent Exotropia
National Eye Institute (NEI)NIH
548 Previous Clinical Trials
1,401,803 Total Patients Enrolled
3 Trials studying Intermittent Exotropia
505 Patients Enrolled for Intermittent Exotropia
Pediatric Eye Disease Investigator GroupNETWORK
18 Previous Clinical Trials
4,430 Total Patients Enrolled
3 Trials studying Intermittent Exotropia
505 Patients Enrolled for Intermittent Exotropia

Media Library

Full-Time Occlusion Therapy (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05462821 — N/A
~12 spots leftby Dec 2024
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