Intermittent Exotropia > Full-Time Occlusion Therapy

Eye Patching for Intermittent Exotropia

(IXT7 Trial)

Recruiting in Palo Alto (17 mi)

+28 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Jaeb Center for Health Research

Disqualifiers: Prior surgery, Diplopia, Strabismus, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Full-Time Occlusion Therapy for Intermittent Exotropia?

Research on part-time occlusion therapy, which is similar to full-time occlusion therapy, shows that it can improve control in patients with intermittent exotropia, suggesting that full-time occlusion might also be effective.

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Is eye patching therapy safe for humans?

The research does not provide specific safety data for eye patching therapy, but it is commonly used in children for conditions like amblyopia and intermittent exotropia, suggesting it is generally considered safe.

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How does full-time occlusion therapy differ from other treatments for intermittent exotropia?

Full-time occlusion therapy (FTO) involves covering one eye completely for most of the day, which is different from part-time patching that only covers the eye for a few hours. This approach aims to improve eye alignment and control by forcing the brain to rely on the weaker eye more consistently.

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Eligibility Criteria

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.

Inclusion Criteria

Patient and/or parent understands protocol, is willing to enroll, and is willing to accept that other (i.e., nonrandomized) treatment for IXT will not be offered by the investigator for 3 months

Birth weight > 1500 grams

My child, aged 3-8, sees a children's eye doctor.

Exclusion Criteria

My vision is good except for needing glasses or contacts.

Severe developmental delay that would interfere with treatment or evaluation

Known allergy to silicone

Participant Groups

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.

Group I: Full Time Patching Experimental Treatment 1 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 Group Active Control 1 Intervention

Participants randomized to observation alone will not be allowed to receive any other treatment for IXT, except refractive correction, for 3 months.

Full-Time Occlusion Therapy is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Full-Time Occlusion Therapy for:

• Amblyopia
• Intermittent Exotropia

🇪🇺 Approved in European Union as Full-Time Occlusion Therapy for:

• Amblyopia
• Intermittent Exotropia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Children's Mercy Hospitals and Clinics Kansas City, MO

Southern College of Optometry Memphis, TN

Univ of California, Irvine- Gavin Herbert Eye Institute Irvine, CA

Ohio State University College of Optometry Columbus, OH

More Trial Locations

Who Is Running the Clinical Trial?

Jaeb Center for Health Research Lead Sponsor

National Eye Institute (NEI) Collaborator

Pediatric Eye Disease Investigator Group Collaborator

References

1. Germany pubmed.ncbi.nlm.nih.gov

The influence of alternate part-time patching on control of intermittent exotropia: a randomized clinical trial. [2021] To evaluate the effect of alternate part-time patching on deviation control in patients with intermittent exotropia in comparison to observation.

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Characteristics of Patients Who Are Not Responsive to Alternate Patching for Overcorrected Intermittent Exotropia. [2018] To compare the characteristics of patients with surgically overcorrected intermittent exotropia treated with alternate patching.

3. India pubmed.ncbi.nlm.nih.gov

Part-time versus full-time occlusion therapy for treatment of amblyopia: A meta-analysis. [2020] To compare full-time occlusion (FTO) and part-time occlusion (PTO) therapy in the treatment of amblyopia, with the secondary aim of evaluating the minimum number of hours of part-time patching required for maximal effect from occlusion.

4. United States pubmed.ncbi.nlm.nih.gov

Surgical Outcome of Intermittent Exotropia With Improvement in Control Grade Subsequent to Part-time Preoperative Occlusion Therapy. [2018] To evaluate the effect of improvement in the control grade of intermittent exotropia using part-time occlusion therapy on the final postoperative outcome.

5. United States pubmed.ncbi.nlm.nih.gov

A Randomized Trial Comparing Part-time Patching with Observation for Intermittent Exotropia in Children 12 to 35 Months of Age. [2023] To determine the effectiveness of part-time patching for treating intermittent exotropia (IXT) in young children.

6. United States pubmed.ncbi.nlm.nih.gov

Overminus Lens Therapy for Children 3 to 10 Years of Age With Intermittent Exotropia: A Randomized Clinical Trial. [2022] This is the first large-scale randomized clinical trial evaluating the effectiveness and safety of overminus spectacle therapy for treatment of intermittent exotropia (IXT).

7. United States pubmed.ncbi.nlm.nih.gov

Factors associated with the effectiveness of part-time patching for intermittent exotropia in children. [2022] To evaluate the factors associated with the efficacy of low-dose part-time patching in children with intermittent exotropia (IXT).

8. India pubmed.ncbi.nlm.nih.gov

Does occlusion therapy improve control in intermittent exotropia? [2020] The aim of this study was to evaluate the effectiveness of occlusion therapy in the control of intermittent exotropia (IXT) in children between 4 and 10 years in Saudi Arabia. This study will highlight the importance of patching IXT patients and assist to approach the proper use of occlusion therapy.

9. United States pubmed.ncbi.nlm.nih.gov

A randomized trial comparing part-time patching with observation for children 3 to 10 years of age with intermittent exotropia. [2023] To determine the effectiveness of prescribed part-time patching for treatment of intermittent exotropia (IXT) in children.