Asynchronous 3D Movies for Lazy Eye

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Retina Foundation of the Southwest

Disqualifiers: Prematurity, Ocular disease, Developmental delay, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests if watching special movies can improve vision in children with amblyopia better than using an eye patch. The movies help the weaker eye work harder, potentially leading to better vision. Watching these movies has been shown to significantly improve vision in children with amblyopia.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Asynchronous 3D Movies for Lazy Eye?

Research shows that using 3D technology and virtual reality for lazy eye treatment can be effective, as it allows both eyes to work together, which is more engaging and can improve compliance compared to traditional patching. Studies have shown positive results in improving vision in children and adults with amblyopia when using these methods. ^{1 2 3 4 5}

How does the Asynchronous 3D Movie treatment for lazy eye differ from other treatments?

The Asynchronous 3D Movie treatment for lazy eye is unique because it uses virtual reality technology to present different images to each eye, encouraging both eyes to work together, unlike traditional methods that often involve patching the stronger eye to force the weaker one to improve. ^{1 2 5 6 7}

Research Team

Eligibility Criteria

This trial is for boys and girls aged 3-8 with lazy eye, who have been wearing glasses for at least 8 weeks without vision improvement. They must not have been born more than 8 weeks early or have other eye/systemic diseases or significant developmental delays.

Inclusion Criteria

I have been diagnosed with a type of lazy eye.

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

The difference in vision between your two eyes is significant.

Exclusion Criteria

You have severe strabismus, where your eyes are misaligned by more than 5 prism diopters.

You were born at least 8 weeks early.

I have another eye or body-wide disease.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

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

6 weeks

3 visits (in-person) at 2, 4, and 6 weeks

Extension

Participants in the asynchronous movie group may continue treatment for an additional 2 or 4 weeks, and the standard-of-care group may switch to movie treatment

4 weeks

2 visits (in-person) at 8 and 10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Asynchronous 3D movies (Behavioural Intervention)
• Patching (Behavioural Intervention)

Trial Overview The study compares two treatments for lazy eye in children: the traditional patching method versus watching asynchronous 3D movies designed to improve vision. The goal is to see if the movie method works better and if kids stick with it more easily.

Participant Groups

Group I: Asynchronous movies Experimental Treatment 1 Intervention

Asynchronous 3D movies

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

Standard-of-care patching with an adhesive patch

Asynchronous 3D movies is already approved in China for the following indications:

Approved in China as Asynchronous 3D Movie Therapy for:

• Anisometropic Amblyopia

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+

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

Findings from Research

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]

A combined treatment of stereoscopic 3D video movies and part-time patching significantly improved visual acuity in amblyopic children compared to patching alone, with a mean improvement of 0.17 logMAR in the combined group versus 0.05 logMAR in the patching group after six weeks.

The combined treatment also enhanced stereoacuity, indicating better binocular function, which was not observed in the patching-only group, highlighting the effectiveness of this innovative approach for children who struggle with traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of binocular therapy as a complementary treatment of part-time patching in older amblyopic children: a randomized clinical trial. Zhu, Q., Zhao, Q., Liang, R., et al.[2023]

The Interactive Binocular Treatment (I-BiT) system is a novel virtual-reality approach designed to treat amblyopia by stimulating both eyes simultaneously, addressing issues of compliance and effectiveness seen with traditional patching methods.

This interactive VR system is adaptable to the patient's age and abilities, making the treatment more engaging and enjoyable, with ongoing research to evaluate its efficacy in improving amblyopia outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified virtual reality technology for treatment of amblyopia. Eastgate, RM., Griffiths, GD., Waddingham, PE., et al.[2019]

Virtual reality-based vision therapy significantly improved binocular visual functions and symptoms in young adults with convergence insufficiency and accommodative dysfunction over a 12-week treatment period, suggesting its effectiveness as a treatment option.

While both virtual reality and traditional office-based therapies showed improvements, a notable difference was found in monocular accommodative facility, favoring the virtual reality group, indicating potential advantages of this innovative approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality-based vision therapy versus OBVAT in the treatment of convergence insufficiency, accommodative dysfunction: a pilot randomized controlled trial. Li, S., Tang, A., Yang, B., et al.[2022]

In a study involving seven adults with amblyopia, watching anaglyphic 3D movies for 20 sessions led to a significant improvement in visual acuity in the amblyopic eye, with an average improvement from 0.42 to 0.25 logMAR (P = 0.02).

The treatment also resulted in a notable enhancement in stereoacuity, with an average improvement from 2.6 to 2.1 log arcsec (P = 0.04), indicating that this method can be an effective option for some adults with amblyopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaglyphic Three-Dimensional Movie: A Simple Binocular Method to Treat Anisometropic or Strabismic Amblyopia in Adults. Mirmohammadsadeghi, A., Sadeghi, M., Kasaee, A., et al.[2022]

Extended reality (XR) devices, such as virtual reality (VR) and augmented reality (AR), can effectively measure and treat binocular vision anomalies by delivering different visual content to each eye, creating a sense of depth through stereopsis.

The integration of eye tracking technology in XR devices enhances their ability to assess and address binocular vision issues, making them a promising tool for both measurement and treatment in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications and implications for extended reality to improve binocular vision and stereopsis. Levi, DM.[2023]

The I-BiT system, designed for home use with eye-tracking capabilities, aims to treat amblyopia through dichoptic stimulation, potentially improving compliance compared to traditional patching methods.

This randomized controlled trial will assess the efficacy of I-BiT in improving visual acuity in 120 children with different types of amblyopia over a 6-week treatment period, with outcomes measured at multiple time points.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical investigation plan for the use of interactive binocular treatment (I-BiT) for the management of anisometropic, strabismic and mixed amblyopia in children aged 3.5-12 years: a randomised controlled trial. Brown, R., Blanchfield, P., Fakis, A., et al.[2021]

References

1. 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]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of binocular therapy as a complementary treatment of part-time patching in older amblyopic children: a randomized clinical trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Modified virtual reality technology for treatment of amblyopia. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Virtual reality-based vision therapy versus OBVAT in the treatment of convergence insufficiency, accommodative dysfunction: a pilot randomized controlled trial. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Anaglyphic Three-Dimensional Movie: A Simple Binocular Method to Treat Anisometropic or Strabismic Amblyopia in Adults. [2022]

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

Applications and implications for extended reality to improve binocular vision and stereopsis. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Clinical investigation plan for the use of interactive binocular treatment (I-BiT) for the management of anisometropic, strabismic and mixed amblyopia in children aged 3.5-12 years: a randomised controlled trial. [2021]