NCT04238065

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Guangzhou Shijing Medical Software · Industry
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Amblyopia

Interventions

Type	Name	Description
DEVICE	Caterna Virtual Reality	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 software"Wechat" to upload vision acuity and choose 2 eyes' video output automaticly.
DEVICE	Spectacles(Best optical corrected distance vision)	Each eye has best corrected vision spectacles with best corrected optical lens.
DEVICE	Patch	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

Timeline

• Start date: 2019-09-04
• Primary completion: 2020-12-31
• Completion: 2021-12-31
• First posted: 2020-01-23
• Last updated: 2020-02-05

Locations

4 sites across 1 country: China