Binocular video games for Lazy Eye

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lazy Eye
Binocular video games - Device
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study whether binocular video games are an effective treatment for amblyopia in children 4-7 and 8-12 years old, and will compare the efficacy to patching.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: at Week 4, Week 8, Week 12, Week 16, Week 26, and Week 52

Week 52
Attain BCVA of 0.1 logMAR or better in the amblyopic eye
Attain a 2-line or better improvement in BCVA in the amblyopic eye
Week 12
Percentage of participants who complete at least 75% of prescribed game play
Week 52
Change in BCVA in the amblyopic eye
Week 52
Change in stereoacuity or binocular video game relative to patching.
Week 8
Change in best corrected visual acuity (BCVA) in the amblyopic eye.
Week 12
Time played as recorded in the diary
Time played as recorded in the video game system
Week 16
Time patched as recorded in the diary
Week 52
Frequency of treatment-emergent Adverse Events

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Patching
1 of 2
Binocular video games
1 of 2
Active Control
Experimental Treatment

95 Total Participants · 2 Treatment Groups

Primary Treatment: Binocular video games · No Placebo Group · Phase 1

Binocular video games
Device
Experimental Group · 1 Intervention: Binocular video games · Intervention Types: Device
Patching
Device
ActiveComparator Group · 1 Intervention: Patching of the sound eye · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at week 4, week 8, week 12, week 16, week 26, and week 52

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,692 Previous Clinical Trials
3,522,944 Total Patients Enrolled

Eligibility Criteria

Age < 18 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Parent(s) or legal guardian(s) must sign written informed consent prior to participation in the study.
You have a BCVA of at least 0.
Patient is able to play the binocular game (Dig Rush and Monster Burner) on at least level 3 on the study tablet under binocular conditions (with red-green glasses).
You are either male or female, and you are between 4 and 7 or 8 and 12 years old.
You have a BCVA of 20/40 to 20/200 Snellen inclusive, 33 to 72 ETDRS letters inclusive.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: October 27th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Pennsylvania100.0%
How old are they?
< 18100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%