Patch-Free Occlusion Therapy for Lazy Eye

Overseen By Eileen E Birch, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Retina Foundation of the Southwest

Disqualifiers: Prematurity, Ocular disease, Developmental delay, others

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

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat lazy eye (amblyopia) in young children. The aim is to determine if a patch-free treatment is more effective and easier for children to adhere to than the traditional adhesive eye patch. Participants will join one of two groups: one testing the patch-free method and the other using the traditional adhesive patch. Suitable candidates for this trial have had lazy eye confirmed by an eye doctor, have worn glasses (if needed) for at least 8 weeks, and have experienced no change in vision during this period. The trial suits families willing to try a new treatment approach and collaborate closely with researchers. As an unphased trial, this study offers families the chance to contribute to innovative research that could enhance treatment options for lazy eye.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does require that you stop using the standard patching treatment for lazy eye during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that patch-free occlusion therapy, which uses special videos to treat lazy eye, can improve vision in children. In one study, children experienced better vision after 16 weeks of this therapy.

Other studies have compared this patch-free method to the traditional use of eye patches. The results suggest both methods are similarly safe and effective. No major safety issues emerged with the patch-free therapy, indicating that children generally tolerate it well.

Overall, these findings support the safety of patch-free occlusion therapy for treating lazy eye in young children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about patch-free occlusion therapy for lazy eye because it offers a more comfortable alternative to the standard adhesive patch treatment. Unlike traditional patching, which can be uncomfortable and stigmatizing for children, patch-free occlusion therapy does not involve adhesive patches and may improve compliance. This new method aims to provide the same therapeutic benefits while eliminating the discomfort and social challenges associated with wearing a physical patch.

What evidence suggests that this trial's treatments could be effective for amblyopia?

Research shows that using special cartoons to help both eyes work together, a method known as patch-free occlusion therapy, can be more effective than traditional eye patching for treating lazy eye in children. In this trial, some participants will receive patch-free occlusion therapy, which studies have shown improves vision more than patching after just two weeks. Specifically, one study demonstrated that after four weeks, children who watched these cartoons had a noticeable improvement in vision, about 0.16 on a specific vision scale. This approach, which engages both eyes simultaneously, has shown promise for improving vision in both children and adults with lazy eye. Evidence suggests that this method may lead to better results and possibly make it easier for people to adhere to the treatment. Meanwhile, other participants in this trial will receive standard-of-care patching with an adhesive patch. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for boys and girls aged 3-10 with lazy eye, who have been wearing glasses for at least 8 weeks without vision improvement. They should not be using standard patching treatment during the study and must have a certain level of visual acuity difference between eyes. Children with developmental delays, born more than 8 weeks premature, or having other eye/systemic diseases or high myopia are excluded.

Inclusion Criteria

You have worn glasses for at least 8 weeks and your vision has not changed during 2 visits that were at least 4 weeks apart.

My child's eye doctor and I agree to not use patching treatment during the study.

The difference in vision between your eyes is greater than a certain amount.

Exclusion Criteria

You have severe nearsightedness.

You have a delay in your development.

You were born more than 8 weeks early.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either patch-free occlusion therapy or standard-of-care occlusion therapy with an adhesive patch at home

12 weeks

3 visits (in-person) at baseline, 6 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with vision reassessed

12 weeks

2 visits (in-person) at 18 weeks and 24 weeks

Open-label extension (optional)

Participants in the patch-free group may continue treatment for an additional 6 or 12 weeks, and the standard-of-care group may switch to patch-free treatment

12 weeks

2 visits (in-person) at 18 weeks and 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adhesive patch
• Patch-free occlusion therapy

Trial Overview The study compares patch-free occlusion therapy to the traditional adhesive patch method in treating lazy eye in children. It aims to see if the new method leads to better vision outcomes and if it's easier for kids to stick with the treatment plan.

How Is the Trial Designed?

Group I: Patch-free occlusion therapy Experimental Treatment 1 Intervention

Group II: Standard-of-care patching with an adhesive patch Active Control 1 Intervention

Adhesive patch is already approved in European Union, United States for the following indications:

Approved in European Union as Adhesive eye patch for:

• Amblyopia (lazy eye)

Approved in United States as Adhesive eye patch for:

• Amblyopia (lazy eye)

Who Is Running the Clinical Trial?

Retina Foundation of the Southwest

Lead Sponsor

Trials

15

Recruited

1,600+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Published Research Related to This Trial

A study involving 24 children evaluated the comfort and mechanical properties of four different brands of eye patches used for amblyopia treatment, revealing significant differences in discomfort, skin reactions, and cosmetic appearance.

Despite no differences in compliance measured electronically, the findings suggest that improving the breathing capability and comfort of eye patches could enhance patient satisfaction and adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comfort of wear and material properties of eye patches for amblyopia treatment and the influence on compliance. Roefs, AM., Tjiam, AM., Looman, CW., et al.[2015]

Recent research suggests that part-time patching may be an effective alternative to traditional full-time patching for treating amblyopia, which is a condition where one eye has reduced vision despite being structurally normal.

This shift in therapy could improve patient compliance and comfort while still aiming to enhance visual acuity in affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Part-time vs. full-time occlusion for amblyopia: evidence for part-time patching. Matta, NS., Silbert, DI.[2018]

In a study of 40 children with anisometropic amblyopia, both alternative flicker glasses (AFG) and traditional patching significantly improved best-corrected visual acuity (BCVA) after 12 weeks, with no significant difference in effectiveness between the two methods.

The AFG group showed notable improvements in contrast sensitivity and stereoacuity, suggesting that this method may enhance binocular function by reducing visual suppression, making it a promising alternative treatment for amblyopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternative Flicker Glass: A New Anti-Suppression Approach to the Treatment of Anisometropic Amblyopia. Yuan, Y., Zhu, C., Wang, P., et al.[2022]

Recent advancements in understanding compliance with amblyopia treatments have improved the effectiveness of patching methods, particularly through the use of quantitative monitoring with occlusion dose monitors.

This review highlights the importance of compliance in both patching and atropine treatments for amblyopia, suggesting that better adherence to treatment protocols can enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance and patching and atropine amblyopia treatments. Wang, J.[2022]

In a study of 36 children aged 4 to 11 with unilateral refractory amblyopia, combined occlusion and atropine therapy (COAT) showed significantly better improvement in best-corrected visual acuity (BCVA) compared to augmented part-time patching over a follow-up period of up to one year.

The COAT group demonstrated a greater mean improvement in BCVA at 3 months, 6 months, and 1 year, indicating that this combined treatment may be more effective for enhancing vision in children with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Combined Occlusion and Atropine Therapy" Versus "Augmented Part-Time Patching" in Children with Refractory/Residual Amblyopia: A Pilot Study. Sachdeva, V., Mittal, V., Gupta, V., et al.[2018]

In a study involving 40 children aged 3 to 12 with anisometropic amblyopia, the Occlu-tab device showed a significantly greater improvement in visual acuity compared to conventional eye patches after 8 weeks of treatment.

Both treatment methods improved visual acuity, but the Occlu-tab group had an average improvement of 0.33 logMAR, while the eye patch group improved by only 0.16 logMAR, indicating that the Occlu-tab may be a more effective option for amblyopia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effectiveness of amblyopia treatment with eye-patch and binocular Occlu-tab for the same treatment duration. Handa, T., Thakkar, H., Ramakrishnan, M., et al.[2023]

The novel dichoptic treatment using polarizing film significantly improved visual acuity in children with anisometric amblyopia compared to traditional eye patch occlusion therapy, based on a study of 58 patients over 2 months.

Patients using the polarizing film showed better compliance rates than those using eye patches, indicating that this method may be more acceptable and easier for children to use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Amblyopia Treatment Effect with Dichoptic Method Using Polarizing Film and Occlusion Therapy Using an Eye Patch. Iwata, Y., Handa, T., Ishikawa, H.[2022]

The occlusion extended-wear soft contact lens (OCL) offers a more comfortable and aesthetically pleasing alternative to traditional eye patches for treating amblyopia, allowing for continuous 24-hour occlusion instead of the limited 6- to 8-hour use of patches.

Patients who switched from eye patches to OCL reported positive responses to the treatment, despite a slight risk of corneal issues, indicating that OCL may be a viable option for those who struggle with conventional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of amblyopia by extended-wear occlusion soft contact lenses. Tsubota, K., Yamada, M.[2018]

A randomized clinical trial involving 75 children aged 4 to 8 years with amblyopia is testing the effectiveness of a novel treatment called I-BiT™, which uses 3D technology and computer games, compared to traditional methods.

The trial will assess changes in visual acuity over 6 weeks of treatment, aiming to improve compliance and outcomes in amblyopia treatment, which traditionally suffers from low adherence to patching therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation and development of a novel binocular treatment (I-BiT™) system using video clips and interactive games to improve vision in children with amblyopia ('lazy eye'): study protocol for a randomised controlled trial. Foss, AJ., Gregson, RM., MacKeith, D., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39270746/

Patch-free streaming contrast-rebalanced dichoptic cartoons ... In our study cohort, a contrast-rebalanced dichoptic cartoon was more effective than patching in treating childhood amblyopia after 2 weeks.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161642025006803

Effectiveness of Video-Based Dichoptic Therapy vs ... Dichoptic therapy has shown promising results in improving vision in children and adults with amblyopia.7, 8, 9 This binocular treatment ...

3. jaapos.org jaapos.org/article/S1091-8531(24)00288-X/abstract

Patch-free streaming contrast-rebalanced dichoptic ... After 4 weeks of dichoptic cartoon treatment, mean visual acuity improvement in the dichoptic group was 0.16 logMAR (95% CI, 0.10-0.21). Conclusions. In our ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11531989/

Patch-free streaming contrast-rebalanced dichoptic cartoons ... In our study cohort, a contrast-rebalanced dichoptic cartoon was more effective than patching in treating childhood amblyopia after 2 weeks. Dichoptic cartoons ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04086524

A Patch Free Treatment for Young Children With Amblyopia The purpose of this study is to test whether a binocular treatment can improve vision and motor function in young children with amblyopia.

6. researchgate.net researchgate.net/publication/383965888_Patch-free_streaming_contrast-rebalanced_dichoptic_cartoons_versus_patching_for_treatment_of_amblyopia_in_children_aged_3_to_5_years_a_pilot_randomized_clinical_trial

Patch-free streaming contrast-rebalanced dichoptic ... These data support the hypothesis that early treatment for amblyopia leads to a better outcome than later treatment and may act as a stimulus for research ...

7. researchgate.net researchgate.net/publication/394698097_The_efficacy_and_safety_of_dichoptic_therapy_in_comparison_to_patching_in_children_with_amblyopia_A_systematic_review_and_meta-analysis

The efficacy and safety of dichoptic therapy in comparison ... DT and PT show comparable outcomes in visual acuity, stereoacuity, compliance and safety based on pooled data. However, these findings may not ...