AmblyopiaNCT04261868
Virtual Reality Game Playing in Amblyopia Therapy
A study testing Virtual Reality and Patching in people with Amblyopia, run by Hamideh Sabbaghi.
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". Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia
- What is being tested?
- Virtual Reality and Patching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2020to 11 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The best corrected visual acuity worse than 0.3 LogMAR
Who cannot join
- Patients with abnormal fixation
- Patients with neurological problems
- Patients with any types of ocular pathologies
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Amblyopia
- Being tested
- Virtual Reality, Patching
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Also called No additional intervention
New treatment for amblyopia therapy using playing games
PatchingOther
Patching
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Dichoptic playing games with fine stimulation will present to the amblyopic eye. Receives: Device: Virtual Reality |
| Patching | Active comparator | Non- amblyopic eye will be recommended to patch. Receives: Other: Patching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity (BCVA)
Change from baseline BCVA at 6 months
Measured: baseline and 6 months after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start11 Mar 2020 (estimated)
- Primary completion11 May 2021 (estimated)
- Study completion11 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamideh Sabbaghi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hamideh Sabbaghi, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261868
- Sponsor's protocol ID
- IR.SBMU.ORC.REC.1398.024
- Status last verified
- Feb 2020
- First submitted
- 30 Jan 2020
- Last updated
- 10 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Game Playing in Amblyopia Therapy
- ClinicalTrials.gov ID
- NCT04261868
- Acronym / sponsor ID
- IR.SBMU.ORC.REC.1398.024
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hamideh SabbaghiUniversity, hospital or other
- Study start
- 11 Mar 2020 (estimated)
- Primary completion
- 11 May 2021 (estimated)
- Study completion
- 11 Jun 2021 (estimated)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: Virtual RealityDichoptic playing games with fine stimulation will present to the amblyopic eye. |
| Patching | Active comparator | Other: PatchingNon- amblyopic eye will be recommended to patch. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The best corrected visual acuity worse than 0.3 LogMAR
Key exclusion criteria (3 listed)
- Patients with abnormal fixation
- Patients with neurological problems
- Patients with any types of ocular pathologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityAlso: No additional interventionNew treatment for amblyopia therapy using playing games | Device | Virtual Reality |
| PatchingPatching | Other | Patching |
Primary outcome
Best Corrected Visual Acuity (BCVA)
Time frame: baseline and 6 months after training
Change from baseline BCVA at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Amblyopia
Recruiting
OCT Eccentric Fixation and Amblyopia in Children
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Non-invasive Induction of Metaplasticity for Amblyopia
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Evaluation of AmblyoFix for the Treatment of Unilateral Amblyopia in Children
Amblyopia
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Augmented Reality-Based Binocular Therapy for Visual Rehabilitation in Adults With Amblyopia
Amblyopia, Anisometropic Amblyopia
Recruiting
Combining Noninvasive Brain Stimulation and Augmented Reality-based Dichoptic Therapy for Treating Amblyopic Adults
Amblyopia, Anisometropic Amblyopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Patching in people with Amblyopia, run by Hamideh Sabbaghi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hamideh Sabbaghi, PhD (989120285930, sabbaghi.opt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (BCVA) (time frame: baseline and 6 months after training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.