Asynchronous 3D Movies for Lazy Eye

Overseen By Reed M Jost, MS

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)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if watching special 3D movies (Asynchronous 3D movies) can improve vision in young children with lazy eye (amblyopia) more effectively than the usual treatment of wearing an eye patch. Researchers seek to understand if children are more likely to adhere to the movie method, as it might be more enjoyable than patching. Children who have had lazy eye for some time, wear glasses, and have not experienced vision changes with them may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity for children to try an innovative and potentially more enjoyable treatment method.

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 prior data suggests that Asynchronous 3D movies are safe for treating amblyopia?

Research has shown that using 3D movies to treat lazy eye (amblyopia) has been explored in various ways. These movies improve vision by displaying different images to each eye, encouraging both eyes to work together. Studies have found this treatment effective in enhancing vision for children with amblyopia.

Regarding safety, no specific reports of negative effects from watching these 3D movies exist. Similar treatments using virtual reality (VR) have been tested in adults and found to be safe, suggesting that 3D movies could also be safe for children. However, parents should monitor their children's responses to any new treatment and report any concerns to the study team. Overall, research presents a positive view of the safety of this new approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using asynchronous 3D movies for treating lazy eye, also known as amblyopia, because this method offers a non-invasive, engaging alternative to the standard treatment of patching the stronger eye. Unlike traditional patching, which can be uncomfortable and socially awkward, 3D movies have the potential to be more enjoyable and encourage better compliance among children. This method leverages technology to stimulate the weaker eye by subtly altering the visual input, promoting better eye coordination and visual improvement without the need for adhesive patches.

What evidence suggests that asynchronous 3D movies could be an effective treatment for amblyopia?

Research has shown that watching 3D movies at different times can improve vision in children with amblyopia, also known as lazy eye. In this trial, participants may receive Asynchronous 3D movie therapy, which has improved vision in the weaker eye, similar to results from using an eye patch. Another group will receive standard-of-care patching with an adhesive patch. Additionally, virtual reality treatments, which function similarly to Asynchronous 3D movies, have demonstrated significant improvements in vision sharpness in young children. These findings suggest that watching 3D movies could effectively replace wearing an eye patch, potentially leading to better results and cooperation from children with amblyopia. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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.

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 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

What Are the Treatments Tested in This Trial?

Interventions

• Asynchronous 3D movies
• Patching

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05439200

NCT05439200 | Video Treatment for Amblyopia The purpose of this study is to determine whether viewing asynchronous movies leads to better visual outcomes in young children with amblyopia than standard-of- ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0882596323001926

Effects of virtual reality on the treatment of amblyopia in ... Virtual reality technology treatment showed significant effects in improving visual acuity in children who were seven years of age or younger with amblyopia.

3. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2806489

A VR-based asynchronous dichoptic treatment for children ... Conclusions : The present study suggests that VR-based asynchronous binocular movie therapy and patching could improve VA of children with congenital cataract.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35264692/

Randomized clinical trial of streaming dichoptic movies versus ... This novel, at-home, binocular movie treatment improved amblyopic eye BCVA after 2 weeks (similar to patching), with additional improvement up to 6 weeks.

5. withpower.com withpower.com/clinical-trials/for-amblyopia

Top Amblyopia Clinical Trials | Power 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- ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40526901/

Safety Evaluation in Healthy Adults of Motion-Based Virtual ... This study investigated the safety of our motion-based virtual reality (VR) dichoptic training app using Japanese Kendama in healthy adult participants.