Virtual Reality Game Playing in Amblyopia Therapy

NCT ID: NCT04261868

Last Updated: 2020-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-11

Study Completion Date

2021-06-11

Brief Summary

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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.

Detailed Description

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Conditions

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Amblyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Virtual Reality

Dichoptic playing games with fine stimulation will present to the amblyopic eye.

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type DEVICE

New treatment for amblyopia therapy using playing games

Patching

Non- amblyopic eye will be recommended to patch.

Group Type ACTIVE_COMPARATOR

Patching

Intervention Type OTHER

Patching

Interventions

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Virtual Reality

New treatment for amblyopia therapy using playing games

Intervention Type DEVICE

Patching

Patching

Intervention Type OTHER

Other Intervention Names

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No additional intervention

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hamideh Sabbaghi

OTHER

Sponsor Role lead

Responsible Party

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Hamideh Sabbaghi

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Hamideh Sabbaghi, PhD

Role: CONTACT

989120285930

Other Identifiers

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IR.SBMU.ORC.REC.1398.024

Identifier Type: -

Identifier Source: org_study_id

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