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Binocular Games for Lazy Eye
N/A
Waitlist Available
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2, 4, and 8 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 4and 8 weeks (for deprivation amblyopia)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a binocular iPad game app is effective in improving visual acuity and reducing interocular suppression in amblyopic children.
Who is the study for?
This trial is for children aged 4-14 with lazy eye (amblyopia) who can play an iPad game. They must have a certain level of vision in their eyes and have been wearing glasses, if needed, for stability. Kids with developmental delays, significant eye misalignment, extreme prematurity or other eye/systemic diseases cannot join.
What is being tested?
The study tests if a binocular iPad game app can improve vision in kids with lazy eye better than the standard treatment which involves patching the stronger eye to make the weaker one work harder.
What are the potential side effects?
While not explicitly listed here, potential side effects may include eyestrain from using the iPad or discomfort from wearing an eye patch over long periods.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2, 4, and 8 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 4and 8 weeks (for deprivation amblyopia)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2, 4, and 8 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 4and 8 weeks (for deprivation amblyopia)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Fixation Stability BCEA during 30 sec fixation assessed using the EyeLink system
Interocular Suppression Dichoptic Motion Coherence Threshold (<7y) & Dichoptic Letter Contrast Threshold (7+ y)
Stereoacuity Randot Preschool Stereoacuity Test
+1 moreAwards & 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: binocular gamesExperimental Treatment1 Intervention
1 hour per day (5 days per week) binocular game play
Group II: patching (occlusion therapy)Active Control1 Intervention
2 hours per day patching of the sound eye (for strabismic, anisometropic, and combined mechanism amblyopia) or current patching regimen (deprivation amblyopia)
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Who is running the clinical trial?
Retina Foundation of the SouthwestLead Sponsor
14 Previous Clinical Trials
1,493 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have delayed development.You have a severe eye alignment problem (strabismus).Children aged 4 to 14 with a lazy eye, where the vision in the weaker eye is between 20/40 and 20/125, the vision in the stronger eye is between 20/16 and 20/25, and there is a big difference in vision between the two eyes.You have a specific type of eye condition or have not seen improvement in your vision with glasses over a certain period of time.You were born at least 8 weeks early.You have other eye or body health problems.
Research Study Groups:
This trial has the following groups:- Group 1: binocular games
- Group 2: patching (occlusion therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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