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VR Games for Lazy Eye

N/A
Recruiting
Research Sponsored by Marjean Kulp
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients ages 5 to 17 years of age
Be younger than 18 years old
Must not have
Previous intraocular or refractive surgery
Diplopia more than once per week over the last week prior to enrollment by parental report
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 16 weeks versus 16 weeks to 32 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the change in amblyopic eye acuity in children aged 5-17 with amblyopia over 16 weeks of treatment with glasses alone vs. VR games plus glasses. #amblyopiatrial #eyecare #VR

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects may include discomfort from wearing VR headsets like eyestrain or headaches and possibly simulator sickness which includes symptoms such as nausea and dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 5 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had eye surgery before.
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I have experienced double vision more than once in the past week.
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I experience seizures triggered by flashing lights.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 16 weeks versus 16 weeks to 32 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 16 weeks versus 16 weeks to 32 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in Mean Change in Amblyopic Eye Visual Acuity
Secondary study objectives
Difference in Change in Stereoacuity/Binocularity
Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity
Difference in Mean Change in Attention
+3 more

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: 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.)

Find a Location

Who is running the clinical trial?

Beta Sigma Kappa - College of Optometrists in Vision DevelopmentUNKNOWN
VividVisionUNKNOWN
Marjean KulpLead Sponsor
~5 spots leftby Dec 2025
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