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NCT04261868 Clinical Trial

Virtual Reality Game Playing in Amblyopia Therapy

Amblyopia Clinical Trial

Official title:
Virtual Reality Game Playing in Amblyopia Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04261868
Other study ID # IR.SBMU.ORC.REC.1398.024
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 11, 2020
Est. completion date June 11, 2021

Study information
Verified date February 2020
Source Shahid Beheshti University of Medical Sciences
Contact Hamideh Sabbaghi, PhD
Phone 989120285930
Email sabbaghi.opt@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date June 11, 2021
Est. primary completion date May 11, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 10 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Virtual Reality
New treatment for amblyopia therapy using playing games
Other:
• Patching
Patching

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hamideh Sabbaghi

Outcome
Type Measure Description Time frame Safety issue
Primary Best Corrected Visual Acuity (BCVA) Change from baseline BCVA at 6 months baseline and 6 months after training
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