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

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.

Conditions

• Amblyopia

Interventions

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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• The First Affiliated Hospital of Beijing University

  collaborator UNKNOWN

• Zhongshan Ophthalmic Center, Sun Yat-sen University

  collaborator OTHER

• Guangzhou Shijing Medical Software

  lead INDUSTRY

Principal Investigators

• Xiaohong Liu · Guangzhou Shijing Medical Software

• Mosheng Zhou · Guangzhou Shijing Medical Software

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-04

Primary Completion

2020-12-31

Completion

2021-12-31

Countries

• China

Study Locations