A Clinical Trial of Caterna Virtual Reality Facilitating Treatment in Children With Amblyopia

Study Overview
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Brief Summary
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It aims to find the effectiveness and the safety of Virtual Reality (Caterna, DOBOSO, item code: SJ-VRS2018) to facilitate amblyopia treatment combining spectacles and occlusion. And it also aims to test whether amblyopia treatment outcomes with spectacles, occlusion and VR are significant better than those without VR, but with spectacles and occlusion. The experiment arm is designed to use the Caterna VR to treat amblyopia for total consistent 13 weeks, 3 times per week, while the control arm is not. Both arms are best optical correction and with patch the non-amblyopia eye 2 hours or 6 hours per day. All eyes are followed up for total 13 weeks.

Detailed Description
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The amblyopia eye will see the video content from Caterna VR a little bit earlier (12 ms) than the other non-amblyopia eye. Also, the illumination and contrast are both adjusted to balance 2 eyes' clarity. One VR treatment sequence is 30 minutes with 5 minutes break in the middle.

Official Title
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A Phase 3 Randomized, Single-blind, Multicenter, Clinical Control Study to Evaluate the Efficacy and Safety of Caterna Virtual Reality Facilitating Treatment Patients With Amblyopia in Children

Conditions
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Amblyopia

Intervention / Treatment
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* Device: Caterna Virtual Reality
* Device: Spectacles(Best optical corrected distance vision)
* Device: Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages from 4 12 years old (including 4 years or 12 years old）； According to the Chinese Medical Association Ophthalmology branch: Strabismus and Pediatric Ophthalmology Experts Consensus of Amblyopia Diagnosis  (2011) as the standard to be diagnosed as amblyopia with abnormal vision than that of age-based norms, that is, caused by abnormal visual development due to strabismus, uncorrected refractive error or form deprivation, the best corrected vision acuity of single eye or both eyes below age-based norms; Or 2 eyes' vision acuity difference larger than 2 lines or more. The normal minimum limit of vision acuity for children of different ages are as the followings: The normal minimum limit of vision acuity for children aged 4 to 5 years is 0.5 (decimal vision acuity); And the normal minimum limit of vision acuity for children aged 6 and over is 0.7(decimal vision acuity). The subject's supervision is fully understand the purpose of the trial and sign an informed consent form; And the subject can cooperate with the whole treatment and related eye examinations。 - Exclusion Criteria: Subjects suffered from tumors, heart disease, hypertension (blood pressure top limitation of children aged 4 to 6 years: 110/70 mmHg, blood pressure top limitation of children aged 7 to 12 years: 120/80 mmHg), or epilepsy; The subject has implanted electronic devices, such as pacemakers, etc. The subject had or has a mental illness; Any eye of the subject due to keratitis, conjunctivitis, internal turning eyelashes and other diseases leading to photophobia or continuing tears; Subject suffered from vertigo, acrophobia or traumatic brain lesions; The subject's eye has congenital glaucoma, congenital ptosis, dacryocystitis, trauma and other significant vision related lesions; Subject received a masking therapy or a treatment instrument for amblyopia treatment before joining this study; The subject participated in other clinical trials before joining this study; For safety reasons or for the benefit of patients, the researchers believe that the patient should not participate in other conditions, such as suffering from a certain severe heart, liver or kidney disease.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One arm receive VR treatment while the other arm does not. Both arms get best optical correction and 2 hours (for mild and moderate amblyopia）patch or 6 hours (for severe amblyopia) patch their non-amblyopia eyes.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR treatment<br>The arm will use the virtual reality headset reproduces dynamic video content with perceptual learning and binocular perception (including stereopsis) that is visually perceived a little bit faster, brighter, and higher contrast to the amblyopia eyes . The each VR therapy length is 30 minutes with 5 minute break after 15 minutes' therapy sequence, 3 times per week, total 13 weeks. All amblyopia eyes are best optical correction or combining patching non-amblyopia eyes if there're more than 2 lines difference best corrected vision acuity. | Device: Caterna Virtual Reality<br>* Vivid interactive games of perceptual learning content, with artificial intelligent sound and scores to feedback vision and actions results, which can be connected to the supervision of cellphone softwareWechat to upload vision acuity and choose 2 eyes' video output automaticly.<br>* Other names: Vision Therapy Software;Device: Spectacles(Best optical corrected distance vision)<br>* Each eye has best corrected vision spectacles with best corrected optical lens.<br>* Other names: Optical correction;Device: Patch<br>* 2 hours patch to the non-amblyopia eye if the other amblyopia eye is mild or moderate amblyopia; 6 hours patch to the non-amblyopia eye if the other amblyopia eye is severe abmlyopia<br>* Other names: Occlusion;|
| Placebo Comparator: control<br>This arm of amblyopia eyes are all best optical correction or combining patching non-amblyopia eyes if there're more than 2 lines difference best corrected vision acuity. No VR therapy. | Device: Spectacles(Best optical corrected distance vision)<br>* Each eye has best corrected vision spectacles with best corrected optical lens.<br>* Other names: Optical correction;Device: Patch<br>* 2 hours patch to the non-amblyopia eye if the other amblyopia eye is mild or moderate amblyopia; 6 hours patch to the non-amblyopia eye if the other amblyopia eye is severe abmlyopia<br>* Other names: Occlusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of amblyopia treatment with VR | General Effectiveness=Number of both cured eyes and effective eyes from total number×100% | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of 8 weeks' VR amblyopia treatment | General Effectiveness=Number of both cured eyes and effective eyes from total number×100% | 8 weeks | 
| Effectiveness of 4 weeks' VR amblyopia treatment | General Effectiveness=Number of both cured eyes and effective eyes from total number×100% | 4 weeks | 
| Stereopsis: distance and near, respectively | Ratio of stereopsis perception=(Number of stereopsis perception /Total number)*100% | 13 weeks | 
| Contrast sensitivity function(CSF) | Difference between those final CSF and baseline CSF | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amblyopia; Virtual Reality