What side effects are associated with this type of intervention?

Common treatments for lazy eye (amblyopia) include occlusion therapy (patching) and visual stimulation methods like video games and virtual reality. Patching can cause skin irritation, discomfort, and social stigma, leading to poor adherence. Visual stimulation methods, such as video games and virtual reality, have shown promise with fewer side effects, primarily involving eye strain or temporary visual discomfort. These methods aim to improve visual outcomes by engaging the amblyopic eye, similar to the asynchronous movie trial.

What prior FDA approvals exist?

The FDA has approved several treatments for amblyopia, commonly known as lazy eye, which traditionally include occlusion therapy (using an adhesive patch over the stronger eye) and pharmacological penalization (using atropine drops to blur vision in the stronger eye). These methods aim to force the use of the amblyopic eye, thereby improving its function. While the concept of using asynchronous movies to engage the amblyopic eye through visual stimulation is innovative, it aligns with the broader strategy of visual stimulation therapies. However, specific FDA approvals for treatments exactly like asynchronous movies are not documented, indicating that this approach is still under investigation and not yet a standard FDA-approved treatment.

What other types of research exist?

Promising novel alternatives for treating amblyopia in 2024 include: 1) Transcutaneous supraorbital nerve stimulation, which has shown efficacy in reducing pain intensity in migraine patients and may have potential applications in amblyopia by stimulating neural pathways. 2) Remote electrical neuromodulation, which uses nonpainful electrical skin stimulation and has demonstrated effectiveness in reducing acute migraine pain, suggesting potential for visual stimulation in amblyopia. 3) Light therapy, particularly using broad-spectrum white light boxes, which has been effective in shifting circadian rhythms and improving sleep disorders, indicating potential for visual and neural stimulation in amblyopia treatment.

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Behavioural Intervention

Asynchronous 3D Movies for Lazy Eye

N/A

Recruiting

Research Sponsored by Retina Foundation of the Southwest

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with strabismic, anisometropic, or combined mechanism amblyopia (visual acuity 0.3-0.8 logMAR)

Child's ophthalmologist and family willing to forgo standard patching treatment during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2, 4, 6, 8, and 10 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While side effects are not detailed, potential issues might include discomfort from not using standard patching or visual strain from viewing asynchronous movies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a type of lazy eye.

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

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I am between 3 and 8 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2, 4, 6, 8, and 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2, 4, 6, 8, and 10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2, 4, 6, 8, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Adherence to patching measured with a sensor and adherence to viewing videos measured with the streaming log data

Change in amblyopic eye visual acuity using a logMAR chart

Change in depth of suppression assessed with the contrast balance index

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Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Asynchronous moviesExperimental Treatment1 Intervention

Asynchronous 3D movies

Group II: Standard-of-care patching with an adhesive patchActive Control1 Intervention

Standard-of-care patching with an adhesive patch

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Lazy Eye (amblyopia) include occlusion therapy (patching the stronger eye), atropine drops, and vision therapy exercises. These treatments work by forcing the brain to use the amblyopic eye, thereby strengthening its visual processing capabilities. Viewing asynchronous movies is a novel approach that also aims to improve visual outcomes by engaging the amblyopic eye through visual stimulation. This method matters for Lazy Eye patients because it can potentially enhance adherence to treatment and provide a more engaging and less intrusive way to improve vision, especially in young children.

[Treatment of strabismus with focused prisms in 1984].Low vision rehabilitation for better quality of life in visually impaired adults.A Review of Cochrane Systematic Reviews of Interventions Relevant to Orthoptic Practice.