Eye Patching for Intermittent Exotropia

(IXT7 Trial)

No longer recruiting at 28 trial locations

Overseen By Katie M Stutz

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Jaeb Center for Health Research

Disqualifiers: Prior strabismus surgery, Diplopia, Paretic strabismus, Craniofacial malformations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if full-time patching of one eye (Full-Time Occlusion Therapy) is more effective than observation alone in improving control of intermittent exotropia, a condition where one eye occasionally turns outward. Participants will either wear a patch on one eye during all waking hours or be observed without additional treatment for three months. Children diagnosed with intermittent exotropia by a pediatric eye specialist and who wear glasses as needed may be suitable for this study. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants the opportunity to contribute to a treatment nearing widespread availability.

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.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It mainly focuses on eye conditions and treatments related to intermittent exotropia.

Is there any evidence suggesting that Full-Time Occlusion Therapy is likely to be safe for humans?

Research has shown that wearing an eye patch all day, known as full-time patching, is generally well-tolerated by children with intermittent exotropia (IXT), a condition where the eyes occasionally drift outward. Studies comparing patching to no treatment have found both options reasonable for managing IXT in children aged 3 to 10 years.

No evidence links full-time patching to serious side effects. While wearing a patch for extended periods might cause minor discomfort or irritation, these issues are usually not severe. The safety of patching is sufficient for it to be often recommended as a standard treatment for IXT. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the full-time occlusion therapy for intermittent exotropia because it offers a non-surgical approach that could provide significant benefits. Unlike the standard of care, which often involves surgery or part-time patching, this method involves daily, alternate eye patching for all waking hours, potentially improving eye alignment and control without invasive procedures. This approach allows the eyes to work together more effectively, offering a promising alternative for managing the condition with a simple, yet rigorous regimen.

What evidence suggests that full-time occlusion therapy is effective for intermittent exotropia?

This trial will compare full-time patching with observation for managing intermittent exotropia (IXT). Studies have shown that wearing an eye patch full-time can help manage IXT, a condition where the eyes sometimes drift outward. Research suggests that this treatment can improve how well the eyes work together, even if it doesn't change the angle at which the eyes drift. Some studies indicate that wearing a patch all day, alternating eyes each day, might be more effective than just monitoring the condition. These findings support the potential benefits of full-time patching in managing IXT. ^{1 2 4 6 7}

Who Is on the Research Team?

Erin C Jenewein, OD

Principal Investigator

Salus University

Stephen P Christiansen, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive full-time patching (all waking hours) for 3 months or are observed without treatment

3 months

Daily monitoring by caregivers, primary outcome visit at 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Full-Time Occlusion Therapy

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Jaeb Center for Health Research

Lead Sponsor

Trials

162

Recruited

36,200+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Pediatric Eye Disease Investigator Group

Collaborator

Trials

20

Recruited

4,800+

Published Research Related to This Trial

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 involving 358 children aged 3 to <11 years with untreated intermittent exotropia (IXT), part-time patching for 3 hours daily over 5 months resulted in a significantly lower deterioration rate (0.6%) compared to observation (6.1%) after 6 months, indicating its efficacy in preventing worsening of the condition.

Both part-time patching and observation are reasonable management strategies for IXT in children, as deterioration is uncommon in either approach, suggesting that patching may offer a slight advantage in maintaining eye alignment.

NCBI (Pubmed)

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. Cotter, SA., Mohney, BG., Chandler, DL., et al.[2023]

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]

In a study of 186 children with intermittent exotropia (IXT), 31.6% showed improvement in their eye alignment and stereoacuity after 1 year of low-dose part-time patching for 2 hours daily.

Factors such as convergence insufficiency, poor distance stereopsis, and larger exotropic deviation at distance were associated with a better response to part-time patching, suggesting it may be an effective non-surgical treatment option for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with the effectiveness of part-time patching for intermittent exotropia in children. Choi, H., Kim, SJ., Jung, J., et al.[2022]

In a study involving 201 children aged 12 to 35 months with untreated intermittent exotropia (IXT), part-time patching for 3 hours daily showed a low rate of deterioration in eye condition, with only 2.2% of children in the patching group experiencing worsening compared to 4.6% in the observation group.

Despite the slight difference in deterioration rates, the study concluded that there is insufficient evidence to recommend part-time patching as an effective treatment for IXT in this age group, as both groups showed similar outcomes in terms of eye alignment and control.

NCBI (Pubmed)

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. Mohney, BG., Cotter, SA., Chandler, DL., et al.[2023]

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]

The meta-analysis of six studies found no statistically significant difference in the effectiveness of full-time occlusion (FTO) compared to part-time occlusion (PTO) therapy for treating amblyopia, indicating both methods can be effective.

However, the analysis suggests that to achieve the best improvement in visual acuity with part-time occlusion, a minimum of six hours of patching per day is recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Part-time versus full-time occlusion therapy for treatment of amblyopia: A meta-analysis. Yazdani, N., Sadeghi, R., Momeni-Moghaddam, H., et al.[2020]

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]

Part-time occlusion therapy significantly improves the control grade of intermittent exotropia in patients, leading to better surgical outcomes, as shown by a higher success rate of 77.6% in those who improved compared to 50% in those who did not.

The therapy also resulted in a notable reduction in the angles of deviation for both distance and near vision, indicating its efficacy in managing this eye condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Outcome of Intermittent Exotropia With Improvement in Control Grade Subsequent to Part-time Preoperative Occlusion Therapy. Bang, SP., Lee, DC., Lee, SY.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05462821

Full-Time Occlusion Therapy for Intermittent Exotropia in ... The purpose of this study is to determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5161813/

Does occlusion therapy improve control in intermittent ... We suggest that alternate occlusion therapy can improve the sensory status and strengthen the fusional amplitudes but does not improve the deviation angle.

3. ucihealth.org ucihealth.org/clinical-trials/ccr-22-65

Randomized Trial of Full-Time Occlusion Therapy ... The purpose of this study is to determine whether full-time patching is more effective than observation for improving distance control of IXT ...

4. mayo.edu mayo.edu/research/clinical-trials/cls-20546174

Full-Time Occlusion Therapy for Intermittent Exotropia in ... The purpose of this study is to determine whether full-time patching is more effective than observation for improving distance control of Intermittent ...

5. bmcophthalmol.biomedcentral.com bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-024-03804-z

Non-surgical therapy for intermittent exotropia: a systematic ... This study aimed to conduct a network meta-analysis to evaluate the efficacy of various non-surgical treatments for intermittent exotropia(IXT).

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/21/NCT05462821/Prot_000.pdf

Signature Page Randomized Trial of Full-Time Occlusion ... observation versus part-time patching for intermittent exotropia, limited to 278 participants with. 841 similar baseline age (3 to <9 years) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4253733/

A Randomized Trial Comparing Part-time Patching with ... Although there is a slightly lower deterioration rate with patching, both management approaches are reasonable for treating 3 to 10 year olds with IXT.