VR Games for Lazy Eye
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Marjean Kulp
Disqualifiers: Myopia, Previous surgery, Ocular co-morbidity, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
The goal of this study is to compare the change in amblyopic eye acuity between treatment periods in children with amblyopia, aged 5-17 years. The main question it aims to answer is: Is a 16-week course of amblyopia treatment using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approx. 25 min/day, 6 days/week more effective for improvement in amblyopic-eye VA, binocularity (stereoacuity, suppression, alignment), contrast sensitivity, attention, oculomotor function, visual-motor integration, and quality of life than 16 weeks of continued glasses alone? Participants will each serve as their own control and complete: Treatment period 1: Continued optical correction (glasses) alone for 16 weeks; Treatment period 2: Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for 16 weeks (approx. 25min/day, 6 days/week) plus continued optical correction
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. It focuses on using glasses and virtual reality games for treatment.
What data supports the effectiveness of the treatment Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for lazy eye?
Research suggests that using virtual reality games for treating amblyopia (lazy eye) can improve depth perception and visual processing speed. Studies have shown that dichoptic video gaming, which presents different images to each eye, can enhance stereoacuity (3D vision) and reduce eye suppression, making it a promising alternative to traditional treatments.12345
Is the VR game treatment for lazy eye safe for humans?
How is the Vivid Vision Therapy treatment for lazy eye different from other treatments?
Eligibility Criteria
Children aged 5-17 with lazy eye (amblyopia) who haven't had treatment in the last 2 weeks. They must have moderate to severe amblyopia due to anisometropia or strabismus, and a stable vision with glasses if needed. Excluded are those with high myopia, seizure risks from light, simulator sickness, other serious eye issues, frequent double vision, Down syndrome or cerebral palsy, severe developmental delays that affect treatment adherence.Inclusion Criteria
Your eyes are a certain distance apart, between 52 and 72 millimeters.
You have been wearing glasses for at least 16 weeks, or until your vision has stayed the same for at least 8 weeks.
Your eyesight is very different between your two eyes.
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Exclusion Criteria
You have Down syndrome or cerebral palsy.
You have a significant delay in your development that would make it hard for you to receive treatment or be evaluated by the doctor.
I have had eye surgery before.
See 6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Period 1
Participants receive continued optical correction (glasses) alone for 16 weeks
16 weeks
Regular visits for monitoring
Treatment Period 2
Participants receive Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for 16 weeks plus continued optical correction
16 weeks
Regular visits for monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games (Other)
Trial OverviewThe study tests whether playing therapeutic virtual reality games for about 25 minutes daily is more effective than just wearing glasses for improving visual acuity and other aspects of vision in children with lazy eye over a period of 16 weeks. Each child will first continue their normal glasses wear then switch to including the VR games.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical CorrectionExperimental Treatment2 Interventions
Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction (16 weeks) (Each participant will complete both study conditions.)
Group II: Optical Correction aloneActive Control1 Intervention
Optical correction alone (16 weeks) (Each participant will complete both study conditions.)
Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Vivid Vision Therapy for:
- Amblyopia (lazy eye)
- Strabismus (eye misalignment)
- Convergence insufficiency
- Binocular vision problems
🇪🇺 Approved in European Union as Vivid Vision Therapy for:
- Amblyopia (lazy eye)
- Strabismus (eye misalignment)
- Convergence insufficiency
- Binocular vision problems
🇨🇦 Approved in Canada as Vivid Vision Therapy for:
- Amblyopia (lazy eye)
- Strabismus (eye misalignment)
- Convergence insufficiency
- Binocular vision problems
🇦🇺 Approved in Australia as Vivid Vision Therapy for:
- Amblyopia (lazy eye)
- Strabismus (eye misalignment)
- Convergence insufficiency
- Binocular vision problems
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Ohio State University College of OptometryColumbus, OH
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Who Is Running the Clinical Trial?
Marjean KulpLead Sponsor
Beta Sigma Kappa - College of Optometrists in Vision DevelopmentCollaborator
VividVisionCollaborator
References
Pilot Study Evaluating the Feasibility of Comparing Computer Game Play with Close Work During Occlusion in Children Aged 2-7 Years with Amblyopia. [2022]Computer games have been used to stimulate vision in amblyopia with varying degrees of success. The aim of this pilot study was to evaluate the feasibility of conducting a randomised controlled trial to test the effectiveness of computer game play compared to close work during occlusion treatment in children.
Virtual Reality Game Playing in Amblyopia Therapy: A Randomized Clinical Trial. [2021]To compare the visual outcome of occlusion therapy with virtual reality game playing as a new therapy for children with amblyopia.
Use of video games for the treatment of amblyopia. [2022]To review the literature up to recent for the use of videos, videogames and dichoptic stimulation as a treatment for amblyopia.
Dichoptic Game Training in Strabismic Amblyopia Improves the Visual Evoked Response. [2023]Dichoptic video gaming offers an alternative approach in amblyopia treatment by allowing different information to be presented in the two eyes, resulting to reduced suppression and/or enhanced fusion. The aim of this case report series is to evaluate the outcome of supervised dichoptic training, with the use of video games in a virtual reality (VR) system, on far and near visual acuity (VA), stereoacuity, and the visual evoked response of an adult and two children with strabismic amblyopia. Results suggest that despite the absence of improvement in VA following supervised dichoptic training, a remarkable increase in stereoacuity was evident with a concurrent decrease in phorias. Moreover, an improvement in the P100 latency of the pattern visual evoked potentials (VEPs) in the amblyopic eye was observed in all participants. Finally, at least two sessions per week were completed for each patient under continuous supervision, implying sufficient compliance and treatment efficiency with dichoptic video gaming. Supervised dichoptic training, consisting of at least 20 hours of video gaming using a VR system, improves stereoacuity and the latency of the visual evoked response in the amblyopic eye. This probably occurs by overcoming its suppression, indicating that the speed of visual processing, as evaluated by pattern VEPs, may precede improvements in VA.
Comparison of Dichoptic Therapy Versus Occlusion Therapy in Children With Anisometropic Amblyopia: A Prospective Randomized Study. [2023]To compare a smartphone-based dichoptic video game with occlusion therapy in children with anisometropic amblyopia.
Adherence to home-based videogame treatment for amblyopia in children and adults. [2021]Clinical relevance: Home-based videogame treatments are increasingly popular for amblyopia treatment. However, at-home treatments tend to be done in short sessions and with frequent disruptions, which may reduce the effectiveness of binocular visual stimulation. These treatment adherence patterns need to be accounted for when considering dose-response relationships and treatment effectiveness.Background: Home-based videogame treatments are increasingly being used for various sensory conditions, including amblyopia ('lazy eye'), but treatment adherence continues to limit success. To examine detailed behavioural patterns associated with home-based videogame treatment, we analysed in detail the videogame adherence data from the Binocular tReatment of Amblyopia with VideOgames (BRAVO) clinical trial (ACTRN12613001004752).Methods: Children (7-12 years), teenagers (13-17 years) and adults (≥ 18 years) with unilateral amblyopia were loaned iPod Touch devices with either an active treatment or placebo videogame and instructed to play for a total of 1-2 hours/day for six weeks at home. Objectively-recorded adherence data from device software were used to analyse adherence patterns such as session length, daily distribution of gameplay, use of the pause function, and differences between age groups. Objectively-recorded adherence was also compared to subjectively-reported adherence from paper-based diaries.Results: One hundred and five of the 115 randomised participants completed six weeks of videogame training. Average adherence was 65% (SD 37%) of the minimum hours prescribed. Game training was generally performed in short sessions (mean 21.5, SD 11.2 minutes), mostly in the evening, with frequent pauses (median every 4.1 minutes, IQR 6.1). Children played in significantly shorter sessions and paused more frequently than older age groups (p < 0.0001). Participants tended to over-report adherence in subjective diaries compared to objectively-recorded gameplay time.Conclusion: Adherence to home-based videogame treatment was characterised by short sessions interspersed with frequent pauses, suggesting regular disengagement. This complicates dose-response calculations and may interfere with the effectiveness of treatments like binocular treatments for amblyopia, which require sustained visual stimulation.
Barriers to successful dichoptic treatment for amblyopia in young children. [2021]In an ongoing randomised clinical trial comparing dichoptic VR video games with patching for amblyopia, we evaluated any potential barriers to successful use of this novel amblyopia treatment method.
Randomized Controlled Trial of Patching versus Dichoptic Stimulation Using Virtual Reality for Amblyopia Therapy. [2023]Purpose: To compare the outcomes of patching to dichoptic stimulation using virtual reality (VR) in moderate and severe amblyopia.Methods: This study was conducted on 86 subjects with unilateral anisometropic and mixed amblyopia. The subjects were randomized to the VR or patching group. The VR group received treatment using the Vivid Vision software (Vivid Vision Inc., San Francisco, USA) with each subject receiving weekly 2 h-sessions for 10 weeks. The patching group was prescribed patching for 10 weeks. Best-corrected visual acuity (BCVA) was measured using a single crowded letter in an ETDRS chart before, after 10 weeks of treatment, and after another 10 weeks of cessation of treatment. Near stereoacuity was measured using the TNO test.Results: Forty-two patients were randomized to the patching group and 44 to the VR group. The median age of the subjects was 12.0 (range 6.0 to 37.0) years. In the VR group, mean amblyopic eye BCVA showed statistically significant improvement by 0.89 line (95% confidence interval {CI}, 0.73 to 1.35 lines; p < 0.001) after 10 weeks of therapy, and after another 10 weeks of follow-up by 1.32 lines from baseline (95% CI, 1.15 to 1.7 lines; p < 0.001). Regarding the patching group, mean BCVA showed statistically significant improvement after 10 weeks by 1.38 lines (95% CI, 0.82 to 1.8 lines; p < 0.001), and after another 10 weeks by 1 line from baseline (95% CI, 0.06-0.147; 0.6 to 1.47 lines; p < 0.001). There was no significant difference between both groups at any time-point (p values >0.05). No serious adverse events were noted. Adults and severe amblyopes in the VR group showed more significant VA improvement than their counterparts in the patching group.Conclusions: Amblyopes treated using VR dichoptic treatment demonstrated statistically significant VA improvement after 10 and 20 weeks of follow-up that is comparable to patching.
Binocular treatment of amblyopia using videogames (BRAVO): study protocol for a randomised controlled trial. [2019]Amblyopia is a common neurodevelopmental disorder of vision that is characterised by visual impairment in one eye and compromised binocular visual function. Existing evidence-based treatments for children include patching the nonamblyopic eye to encourage use of the amblyopic eye. Currently there are no widely accepted treatments available for adults with amblyopia. The aim of this trial is to assess the efficacy of a new binocular, videogame-based treatment for amblyopia in older children and adults. We hypothesise that binocular treatment will significantly improve amblyopic eye visual acuity relative to placebo treatment.