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Virtual Reality Game Playing in Amblyopia Therapy

Virtual Reality Game Playing in Amblyopia Therapy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04261868
Enrollment
50
Registered
2020-02-10
Start date
2020-03-11
Completion date
2021-06-11
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia

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.

Interventions

DEVICEVirtual Reality

New treatment for amblyopia therapy using playing games

OTHERPatching

Patching

Sponsors

Hamideh Sabbaghi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
Yes

Inclusion criteria

\- The best corrected visual acuity worse than 0.3 LogMAR

Exclusion criteria

* Patients with abnormal fixation * Patients with neurological problems * Patients with any types of ocular pathologies

Design outcomes

Primary

MeasureTime frameDescription
Best Corrected Visual Acuity (BCVA)baseline and 6 months after trainingChange from baseline BCVA at 6 months

Contacts

Primary ContactHamideh Sabbaghi, PhD
sabbaghi.opt@gmail.com989120285930

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026