Virtual Reality Game Playing in Amblyopia Therapy
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
Background: "Amblyopia is a neurodevelopmental disorder in both monocular and binocular functions and it extends even beyond the primary visual integration centers", therefore, amblyopia is not a "lazy eye" but it is a "lazy brain". Purpose: The investigators aimed to compare the visual outcome of occlusion therapy with virtual reality game playing as a new therapy on amblyopic children. Methods: This RCT was performed on 50 children with unilateral amblyopia ,4 to 10 years old. They were randomly divided to case and control (each= 25) groups. case group were trained binocularly using the virtual reality games through head set for one hour a day, 5 days in a week for 4 to 6 weeks. Controls occluded their non- amblyopic eyes, 2, 4 and 6 hours for mild (0.2 to 0.3 LogMAR), moderate (0.3 to 0.6 LogMAR) and severe (BCVA \< 0.6 LogMAR) amblyopia, respectively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2020
CompletedFirst Posted
Study publicly available on registry
February 10, 2020
CompletedStudy Start
First participant enrolled
March 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2021
CompletedFebruary 10, 2020
February 1, 2020
1.2 years
January 30, 2020
February 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Best Corrected Visual Acuity (BCVA)
Change from baseline BCVA at 6 months
baseline and 6 months after training
Study Arms (2)
Virtual Reality
EXPERIMENTALDichoptic playing games with fine stimulation will present to the amblyopic eye.
Patching
ACTIVE COMPARATORNon- amblyopic eye will be recommended to patch.
Interventions
New treatment for amblyopia therapy using playing games
Eligibility Criteria
You may qualify if:
- \- The best corrected visual acuity worse than 0.3 LogMAR
You may not qualify if:
- Patients with abnormal fixation
- Patients with neurological problems
- Patients with any types of ocular pathologies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hamideh Sabbaghilead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 30, 2020
First Posted
February 10, 2020
Study Start
March 11, 2020
Primary Completion
May 11, 2021
Study Completion
June 11, 2021
Last Updated
February 10, 2020
Record last verified: 2020-02