What side effects are associated with this type of intervention?

Full-time patching for Intermittent Exotropia can lead to several side effects, including skin irritation or rash around the patched eye, discomfort, and potential social or psychological impacts due to the visibility of the patch. Additionally, there is a risk of amblyopia (lazy eye) developing in the patched eye if the treatment is not carefully monitored. Other common treatments for IXT, such as corrective glasses or vision therapy, generally have fewer side effects but may not be as effective in improving eye alignment as full-time patching.

What prior FDA approvals exist?

There is no specific mention of FDA-approved drugs for the treatment of Intermittent Exotropia in the provided context. However, full-time patching, which forces the use of the non-patched eye to improve control of eye alignment, is a non-pharmacologic treatment method commonly used for this condition. This approach aims to strengthen the weaker eye and improve binocular vision. For more detailed treatment options, consulting with a healthcare provider is recommended.

What other types of research exist?

Promising alternatives to full-time patching for intermittent exotropia include adjustable suture surgery, which allows for postoperative adjustment to improve alignment, and nonadjustable suture surgery, both of which have shown positive outcomes in alignment and binocular status. Additionally, strabismus surgery has been shown to improve distance stereo acuity in a significant percentage of patients.

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Behavioural Intervention

Eye Patching for Intermittent Exotropia (IXT7 Trial)

Phase 3

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

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to see if covering one eye all day helps children with an eye condition where one eye turns outward.

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.

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.

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active 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

Do I qualify?Apply below to find out

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.