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Behavioural Intervention
Asynchronous 3D Movies 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
Diagnosed with strabismic, anisometropic, or combined mechanism amblyopia (visual acuity 0.3-0.8 logMAR)
Child's ophthalmologist and family willing to forgo standard patching treatment during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2, 4, 6, 8, and 10 weeks
Awards & highlights
Study Summary
This trial tests if watching movies can improve vision in kids with amblyopia, and if it helps them stick to treatment better.
Who is the study for?
This trial is for boys and girls aged 3-8 with lazy eye, who have been wearing glasses for at least 8 weeks without vision improvement. They must not have been born more than 8 weeks early or have other eye/systemic diseases or significant developmental delays.Check my eligibility
What is being tested?
The study compares two treatments for lazy eye in children: the traditional patching method versus watching asynchronous 3D movies designed to improve vision. The goal is to see if the movie method works better and if kids stick with it more easily.See study design
What are the potential side effects?
While side effects are not detailed, potential issues might include discomfort from not using standard patching or visual strain from viewing asynchronous movies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of lazy eye.
Select...
My child's eye doctor and we agree to not use patching treatment during the study.
Select...
I am between 3 and 8 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2, 4, 6, 8, and 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2, 4, 6, 8, and 10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Adherence to patching measured with a sensor and adherence to viewing videos measured with the streaming log data
Change in amblyopic eye visual acuity using a logMAR chart
Change in depth of suppression assessed with the contrast balance index
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Asynchronous moviesExperimental Treatment1 Intervention
Asynchronous 3D movies
Group II: Standard-of-care patching with an adhesive patchActive Control1 Intervention
Standard-of-care patching with an adhesive patch
Find a Location
Who is running the clinical trial?
Retina Foundation of the SouthwestLead Sponsor
14 Previous Clinical Trials
1,545 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe strabismus, where your eyes are misaligned by more than 5 prism diopters.You were born at least 8 weeks early.I have been diagnosed with a type of lazy eye.I have another eye or body-wide disease.My child's eye doctor and we agree to not use patching treatment during the study.You have a delay in your development.You have severe nearsightedness.The difference in vision between your two eyes is significant.You have worn glasses, if necessary, for at least 8 weeks and your vision has not changed during two visits that were at least 4 weeks apart.I am either male or female.I am between 3 and 8 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Asynchronous movies
- Group 2: Standard-of-care patching with an adhesive patch
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are octogenarians being admitted into this experiment?
"This clinical trial requires participants to be between 3 and 8 years old. Additionally, there are 19 trials specifically intended for minors under the age of 18 and one dedicated to seniors over 65."
Answered by AI
Is there still room for participation in this research trial?
"Affirmative. The information hosted on clinicaltrials.gov implies that this medical trial is looking for participants, which was initially posted on March 10th 2023 and recently updated June 13th 2023. A total of 44 individuals need to be recruited from a single site."
Answered by AI
What are the eligibility requirements for taking part in this research trial?
"To be included in this clinical study, potential patients must suffer from strabismus and fall between the ages of 3 to 8 years old. In total, 44 participants are being sought for enrollment."
Answered by AI
What is the scale of this clinical investigation?
"Affirmative. Clinicaltrials.gov data displays that this research endeavour, which was initially advertised on March 10th 2023, is presently recruiting participants. 44 patients need to be enrolled from one medical institution."
Answered by AI
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