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Behavioural Intervention
Binocular Games for Lazy Eye
N/A
Recruiting
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
Age 4-10 years
Diagnosis of strabismic, anisometropic, or combined mechanism amblyopia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline vs 2, 4, 6, 8, 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a new, improved treatment for amblyopia (lazy eye) is more effective than the current standard of care.
Who is the study for?
This trial is for children aged 4-10 with lazy eye, who have a certain level of vision in their amblyopic (weak) and fellow eyes. They must be able to play binocular games, have not received similar treatments recently, and agree to avoid patching during the study. Children with significant strabismus, premature birth history, other diseases or developmental delays cannot participate.
What is being tested?
The trial tests if playing specially designed binocular games can more effectively treat lazy eye in kids compared to traditional methods. It aims for a complete and stable visual improvement over a 12-week period without using an eye patch.
What are the potential side effects?
While this study involves non-invasive treatment through games, potential side effects may include eyestrain or headaches due to prolonged screen time or frustration if difficulties arise while playing the games.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 4 and 10 years old.
Select...
I have been diagnosed with a type of lazy eye.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline vs 2, 4, 6, 8, 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline vs 2, 4, 6, 8, 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in stereoacuity
Change in suppression
Change in visual acuity of the amblyopic eye
Other study objectives
Change in accommodation
Change in fixation stability
Change in motion perception
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Reduced Contrast IncrementExperimental Treatment1 Intervention
Group II: No Contrast IncrementExperimental Treatment1 Intervention
Group III: Standard Contrast IncrementActive Control1 Intervention
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Who is running the clinical trial?
Retina Foundation of the SouthwestLead Sponsor
14 Previous Clinical Trials
1,469 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your "lazy" eye has a visual acuity between 0.3 and 0.8 on a special eye chart.My child's eye doctor and we agree not to use patching treatment for 12 weeks.My child can understand and play games using both eyes together.I am between 4 and 10 years old.I am either male or female.I have an eye or other health condition alongside my main illness.Your vision in the other eye is worse than 20/25 with glasses or contact lenses.There is a big difference in vision between your two eyes.I have received treatment for lazy eye in the last 3 months.I have been diagnosed with a type of lazy eye.You wear glasses, if needed, and your vision hasn't changed with glasses over two visits that were 4 weeks apart.You were born more than 8 weeks early.You have an eye condition where your eyes are misaligned by more than 5 prism diopters.You have a delay in your development compared to others your age.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Contrast Increment
- Group 2: No Contrast Increment
- Group 3: Reduced Contrast Increment
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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