Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
44 participants
INTERVENTIONAL
2023-08-23
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Patch-free Occlusion Therapy
NCT05440448
Study of Binocular Computer Activities for Treatment of Amblyopia
NCT02200211
Treating Amblyopia in Adults With Interactive Video Games
NCT03906994
Light-deprivation Utilized to Mitigate Amblyopia
NCT02685423
Binocular Visual Therapy and Video Games for Amblyopia Treatment.
NCT03655912
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Children will participate in their assigned occlusion therapy at home for 6 weeks (primary outcome). Adherence will be objectively monitored. Vision will be re-assessed at 2 and 4 weeks and all tests will be repeated at 6 weeks. The asynchronous movie group will have an option to continue for and additional 2 or 4 weeks (10 weeks total). The standard-of-care occlusion group will be offered the opportunity to use the movie treatment at the 6 week visit through 10 weeks. Children who choose to remain in the study beyond the 6 week primary outcome visit will have vision reassessed at 8 and 10 weeks.
The primary analysis will be a comparison of improvement in amblyopic eye visual acuity (baseline-6 weeks) between the movie group and the standard-of-care patching group. Secondary analyses will include comparisons of adherence to each treatment, comparison of the proportion of children in each group with visual acuity ≤0.1 logMAR (recovered) at 6 weeks and 95% CIs, comparisons of changes in extent of suppression, depth of suppression, stereoacuity, motor skills standard scores, self-perception scores, and PedEyeQ domain scores. Associations among hours of treatment, changes in visual acuity, suppression, and stereoacuity, will be explored and modeled for dose-response relationships. In exploratory analyses, we will examine whether there are additional improvements in visual acuity, suppression, or stereoacuity between 6 and 10 weeks for the movie group (8 and 10 weeks means and 95% CIs).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Asynchronous movies
Asynchronous 3D movies
Asynchronous 3D movies
3D movies streamed at home for viewing on a handheld lenticular 3D screen
Standard-of-care patching with an adhesive patch
Standard-of-care patching with an adhesive patch
Patching
Adhesive patch to cover the fellow eye
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Asynchronous 3D movies
3D movies streamed at home for viewing on a handheld lenticular 3D screen
Patching
Adhesive patch to cover the fellow eye
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* male and female
* strabismic, anisometropic, or combined mechanism amblyopia (visual acuity 0.3-0.8 logMAR)
* interocular visual acuity difference ≥0.3 logMAR
* wearing glasses (if needed) for a minimum of 8 weeks with no change in visual acuity at 2 visits ≥4 weeks apart
* child's ophthalmologist and family willing to forgo standard patching treatment during the study
Exclusion Criteria
* coexisting ocular or systemic disease
* developmental delay
* strabismus \>5 pd
* myopia \> -3.00D
3 Years
7 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Eye Institute (NEI)
NIH
Retina Foundation of the Southwest
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Eileen Birch
Senior Research Scientist
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Retina Foundation
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RFSW113B
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.