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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

IXT7 Trial 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.

IXT7 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

New ocular deviation or worsening of preexisting deviation by at least 10 pd

100%

80%

60%

40%

20%

Study treatment Arm

Control

Intensified Treatment

IXT7 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Jaeb Center for Health ResearchLead Sponsor

152 Previous Clinical Trials

34,597 Total Patients Enrolled

3 Trials studying Intermittent Exotropia

505 Patients Enrolled for Intermittent Exotropia

National Eye Institute (NEI)NIH

546 Previous Clinical Trials

1,401,856 Total Patients Enrolled

3 Trials studying Intermittent Exotropia

505 Patients Enrolled for Intermittent Exotropia

Pediatric Eye Disease Investigator GroupNETWORK

17 Previous Clinical Trials

4,192 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sample size for this experiment?

"Indeed, the information on clinicaltrials.gov shows that this experiment is in the process of recruiting participants. It was initially posted on November 21st 2022 and subsequently updated a week later. The trial requires 72 patients to be recruited from two medical facilities."

Answered by AI

Is it possible for individuals in their fourth decade of life to participate in this experiment?

"This clinical trial is looking for participants aged 3 to 8. Furthermore, there are 7 studies open to minors and one catered specifically towards seniors above the age of 65."

Answered by AI

Who is eligible to contribute to this clinical trial?

"This trial requires 72 children aged 3 to 8 who present with intermittent exotropia. Furthermore, the visual acuity of participants must be 20/50 (at least 63 letters) for those three years and older, 20/40 (68 characters or more) for four-year olds, 20/32 (73 characters or higher) for five to six year olds, and finally a minimum of 20/25 (78 symbols or greater)for seven to nine-year old participants. Additionally, their near point convergence must range between 0° - 50° as determined by PACT measurements while ensuring distance exodeviation falls within 15° -"

Answered by AI

Is this investigation currently accepting new participants?

"As per clinicaltrials.gov, the medical trial is still searching for willing participants who meet the criteria set out by the researchers. This research was first posted on November 21st 2022 and has been updated as recently as November 28th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Full-Time Occlusion Therapy for Intermittent Exotropia in Children

2022. "Full-Time Occlusion Therapy for Intermittent Exotropia in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05462821.