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

Trial Summary

What is the purpose of this trial?

The purpose of the study is to determine whether a patch-free occlusion therapy leads to better visual outcomes in young children with amblyopia than standard-of-care occlusion therapy with an adhesive patch and whether this is associated with better adherence to the treatment.

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.

What data supports the effectiveness of the treatment for lazy eye?

Research shows that dichoptic therapy, which involves using different images for each eye to improve vision, can be more effective and better tolerated than traditional eye patching for treating lazy eye. A study found that using a polarizing film for dichoptic treatment led to significant improvements in vision and higher compliance compared to using an eye patch. ^{1 2 3 4 5}

Is patch-free occlusion therapy for lazy eye safe?

Patch-free occlusion therapy, like traditional eye patches, is generally safe, but traditional patches can cause skin reactions. An alternative, occlusion soft contact lenses, may have a slight risk of corneal issues, but patients often respond positively to them. ^{1 6 7 8 9}

How is Patch-Free Occlusion Therapy for Lazy Eye different from other treatments?

Patch-Free Occlusion Therapy is unique because it uses dichoptic therapy, which involves presenting different images to each eye to improve vision, unlike traditional eye patches that cover one eye. This method can be more comfortable and improve compliance compared to wearing an eye patch. ^{1 2 3 5 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Comfort of wear and material properties of eye patches for amblyopia treatment and the influence on compliance. [2015]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of Amblyopia Treatment Effect with Dichoptic Method Using Polarizing Film and Occlusion Therapy Using an Eye Patch. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Alternative Flicker Glass: A New Anti-Suppression Approach to the Treatment of Anisometropic Amblyopia. [2022]

4. England 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. [2021]

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

Part-time vs. full-time occlusion for amblyopia: evidence for part-time patching. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Compliance and patching and atropine amblyopia treatments. [2022]

7. India pubmed.ncbi.nlm.nih.gov

Comparison of the effectiveness of amblyopia treatment with eye-patch and binocular Occlu-tab for the same treatment duration. [2023]

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

"Combined Occlusion and Atropine Therapy" Versus "Augmented Part-Time Patching" in Children with Refractory/Residual Amblyopia: A Pilot Study. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment of amblyopia by extended-wear occlusion soft contact lenses. [2018]