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

Amblyopia Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04238065
Study type Interventional
Source Guangzhou Shijing Medical Software
Contact Jenny Qiu, MD
Phone +8618510386815
Email qiukk@topeye.cn
Status Recruiting
Phase N/A
Start date September 4, 2019
Completion date December 31, 2021
View Details
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