Eye Patching for Intermittent Exotropia

(IXT7 Trial)

Recruiting at28 trial 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. ^{1 2 3 4 5}

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. ^{3 5 6 7 8}

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. ^{1 3 5 8 9}

Research Team

Stephen P Christiansen, MD

Principal Investigator

Boston Children's Hospital

Erin C Jenewein, OD

Principal Investigator

Salus University

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

Treatment Details

Interventions

• Full-Time Occlusion Therapy (Behavioural Intervention)

Trial Overview 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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Jaeb Center for Health Research

Lead Sponsor

Trials

162

Recruited

36,200+

Dr. Roy W. Beck

Jaeb Center for Health Research

Chief Medical Officer since 2022

MD, PhD

Adam Glassman

Jaeb Center for Health Research

Chief Executive Officer since 2023

PhD in Biostatistics

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Dr. Michael F. Chiang

National Eye Institute (NEI)

Chief Executive Officer since 2020

MD from Harvard Medical School

Dr. Richard Lee

National Eye Institute (NEI)

Chief Medical Officer since 2021

MD, PhD from Harvard Medical School

Pediatric Eye Disease Investigator Group

Collaborator

Trials

20

Recruited

4,800+

Findings from Research

In a study of 76 children aged 3-8 with intermittent exotropia, alternate part-time patching significantly improved deviation control compared to observation, particularly noted at both near and far distances after 3 and 6 months.

While stereoacuity (the ability to perceive depth) did not show significant differences between the patching and observation groups, the patching group exhibited greater improvements in stereoacuity from baseline, indicating potential benefits beyond just deviation control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of alternate part-time patching on control of intermittent exotropia: a randomized clinical trial. Akbari, MR., Mehrpour, M., Mirmohammadsadeghi, A.[2021]

In a study of 51 patients with surgically overcorrected intermittent exotropia, 29 patients responded positively to alternate patching, while 22 did not, indicating that this treatment can be effective for some individuals.

Factors such as being female, having a larger preoperative exodeviation, and starting alternate patching later were associated with a lack of response to treatment, suggesting that these characteristics may help identify patients who might struggle with this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of Patients Who Are Not Responsive to Alternate Patching for Overcorrected Intermittent Exotropia. Kim, JY., Kim, HR., Lee, SJ.[2018]

Overminus spectacle therapy significantly improved distance control of intermittent exotropia (IXT) in children after 12 months of treatment, with a mean control score of 1.8 compared to 2.8 in the nonoverminus group (P < 0.001).

However, the improvement in exotropia control was not sustained after the treatment was tapered off, as scores were similar between groups at 18 months, and the overminus group experienced a greater myopic shift, with 17% of children showing a shift greater than 1.00 D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overminus Lens Therapy for Children 3 to 10 Years of Age With Intermittent Exotropia: A Randomized Clinical Trial. Chen, AM., Erzurum, SA., Chandler, DL., et al.[2022]

In a study of 21 untreated children with intermittent exotropia (IXT), occlusion therapy showed that 11% of participants had a significant reduction in their eye deviation angle, while 55.5% improved their fusional amplitudes to normal levels.

The therapy was effective in enhancing sensory status and control of IXT, suggesting it can be a useful non-surgical option to delay surgery and potentially improve surgical outcomes in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does occlusion therapy improve control in intermittent exotropia? AlKahmous, LS., Al-Saleh, AA.[2020]

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]

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

Characteristics of Patients Who Are Not Responsive to Alternate Patching for Overcorrected Intermittent Exotropia. [2018]

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

Part-time versus full-time occlusion therapy for treatment of amblyopia: A meta-analysis. [2020]

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]

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]

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]

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

Factors associated with the effectiveness of part-time patching for intermittent exotropia in children. [2022]

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

Does occlusion therapy improve control in intermittent exotropia? [2020]

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]