Amblyopia and Stereoptic Games for Vision

Summary

Amblyopia is the most common developmental vision disorder in children, caused by abnormal visual experience in early life, especially a difference in refraction between the eyes, a misalignment of the eye axes, a combination of both. Besides a significant reduced visual acuity, the patients show deficits in 3D vision and functional vision impairment like reduced reading speed, selective attention or motor control skills. The gold standard treatment for amblyopia, occlusion therapy, can lead to relapses or residual amblyopia (i.e., amblyopia that persist into adulthood). The current study aims to test the efficacy of a novel home-based child-friendly rehabilitation program for amblyopia, Vivid Vision Home, involving playing serious videogames on a virtual reality (VR) headset at home. The VR training will be compared to standard care (wearing a spectacle correction) and to age-matched typically developing individuals. A cross-over design will be used so that each participant will receive both treatments (games, spectacles). There is a growing number of studies showing benefits of binocular stimulation for visual acuity and stereovision, but provided mainly by level III studies, with a need for rigorous level I or II studies, using more engaging therapies, to confirm or refute the efficacy of this approach as an adjunct or replacement for current amblyopia treatments. Embedding binocular stimulation in engaging, immersive serious games delivered on VR headsets at home, as implemented by Vivid Vision Home, can address this question.

Conditions

• Amblyopia
• Healthy

Interventions

DEVICE

Vivid Vision Home

The study intervention consists of playing serious games (Vivid Vision, San Francisco, USA) embedded in a virtual reality headset in a home environment 5 days a week for 30 minutes over 8 weeks (20 h of total gaming).

BEHAVIORAL

Refractive error correction

The control intervention will be refractive error correction that consists of wearing the lenses with the prescribed correction for 2 months.

Sponsors & Collaborators

• University Hospital, Geneva

  collaborator OTHER

• University of Lausanne Hospitals

  collaborator OTHER

• Eye Hospital Jules Gonin

  collaborator OTHER

• Pawel Matusz, PhD

  lead OTHER

Principal Investigators

• Heimo Steffen, MD · University Hospital, Geneva

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

6 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-12-06

Primary Completion

2024-12-31

Completion

2024-12-31

FDA Device

Yes

Countries

• Switzerland

Study Locations