A paper on the safety of an unapproved VR-based software medical device for pediatric amblyopia training in healthy adults has been published in JMIR Formative Research.
We are pleased to announce that a paper on the safety evaluation in healthy adults of a VR-based pediatric amblyopia training software medical device using kendama (this product, *unapproved medical device) has been published in "JMIR Formative Research."
This study prospectively examined 20 healthy adults for any adverse effects on the eyes or discomfort symptoms from this product, and was the first to demonstrate the safety of using this product.
About this paper
Amblyopia is a visual impairment in one or both eyes, affecting about 5% of the total population, and is a major cause of visual impairment in children. Conventional treatment for pediatric amblyopia trains the amblyopic eye by occluding the healthy eye with an eye patch in addition to full-correction glasses. However, this method can impose significant stress on children and may make continuation of treatment difficult.
With this product, there is potential to train the amblyopic eye while playing a VR kendama game, and improved adherence (treatment continuation rate) is expected.
In this study, as a prospective interventional trial, 20 healthy young adults (median age 21; 16 women) used this product for 30 minutes, and 9 items (eye symptoms, physical discomfort, arm fatigue, and VR sickness) were evaluated by questionnaire before and after use.
As a result, no symptoms such as eye fatigue, blurriness, dryness, or VR sickness were observed, and no serious adverse events were reported.
Future developments
Going forward, we aim to obtain medical device approval for this product and plan to conduct specified clinical research on its effectiveness in pediatric amblyopia patients. In addition, we will continue to accumulate safety and efficacy data and accelerate development toward use in real-world clinical practice.
[Publication information]
Journal: JMIR Formative Research
Article title: Safety Evaluation in Healthy Adults of Motion-Based Virtual Reality Dichoptic Training for Pediatric Patients With Amblyopia: Prospective Intervention Study
Press release article