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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 16 weeks versus 16 weeks to 32 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 5 and 17 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 16 weeks versus 16 weeks to 32 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Difference in Mean Change in Amblyopic Eye Visual Acuity

Secondary outcome measures

Difference in Change in Stereoacuity/Binocularity

Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity

Difference in Mean Change in Attention

+3 more

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.)

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beta Sigma Kappa - College of Optometrists in Vision DevelopmentUNKNOWN

VividVisionUNKNOWN

Marjean KulpLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age criterion for this clinical research encompass individuals over fifty years old?

"The minimum age of entry to this medical trial is 5 and the maximum age stands at 17, in compliance with the predetermined eligibility requirements."

Answered by AI

Am I eligible to engage in this medical research?

"This clinical trial is in search of 8 participants who suffer from amblyopia and fall between the ages 5 to 17. Eligibility criteria for this study requires applicants meet these two constraints."

Answered by AI

Are there opportunities for volunteers to join this trial at present?

"Affirmative. According to data hosted on clinicaltrials.gov, this medical trial is actively enrolling patients as of September 15th 2023 and was initially posted the same day. The study needs 8 volunteers from a single site in order to proceed with their research."

Answered by AI

How many participants are currently engaged in this research endeavor?

"Affirmative, the clinicaltrials.gov database shows that this medical experiment is currently seeking participants. It was initially launched on September 15th 2023 and has been modified since then. A total of 8 individuals are required between 1 site for recruitment purposes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Novel Amblyopia Treatment With Virtual Reality Games

Marjean Kulp 2023. "Novel Amblyopia Treatment With Virtual Reality Games". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06049459.

All > Amblyopia