InnoJin Inc. Publishes Protocol Paper on Multicenter Specific Clinical Study Evaluating the Efficacy of a VR-Based Training Program Medical Device for Pediatric Amblyopia (Unapproved)

InnoJin Inc. (Headquarters: Bunkyo-ku, Tokyo), a university-launched startup company, has initiated a specific clinical study to evaluate the efficacy of its "VR-based training program medical device for pediatric amblyopia (unapproved)," which is currently under development (implementation approval obtained on August 26, 2025), and has published a protocol paper summarizing the study's execution plan.

Background of the Study

Amblyopia (lazy eye) is a condition in which the vision in one or both eyes does not develop properly, with an incidence rate of approximately 1% to 5% in children. It is estimated that there are approximately 210,000 amblyopia patients in Japan, with an associated social loss estimated at approximately 2.2 trillion yen.

Standard treatment for amblyopia generally involves wearing refractive corrective glasses and performing "occlusion therapy" (patching) using an eye patch. However, because occlusion therapy involves covering the eye that can see well, it imposes a significant psychological and physical burden on children, and it is not uncommon for them to find it difficult to continue the treatment. Furthermore, children's visual function development has a sensitive period until around the age of 10, and if this period is missed, sufficient therapeutic effects may not be achieved.

A New Approach Utilizing VR

Against this background, our company is working on the development of an innovative training program medical device for amblyopia that utilizes Virtual Reality (VR) technology. Through this new treatment approach, where children can naturally train their amblyopia just by wearing VR goggles and playing games like kendama, table tennis, and tennis, we aim to reduce the psychological burden associated with amblyopia training, and to improve treatment adherence (the ability to voluntarily proceed with treatment) as well as therapeutic efficacy. If the efficacy of pediatric amblyopia training using VR is confirmed in this study, we aim to obtain medical device approval in the future, providing the treatment as an amblyopia training program that can also be conducted at home through medical institutions.

Table Tennis Game Scene

Tennis Game Scene

About the Protocol Paper

A protocol refers to the implementation plan and procedures of a study, and a protocol paper is a document that summarizes them in the form of a thesis along with academic information. Our company published a protocol paper regarding the multicenter specific clinical study on the efficacy of the VR-based training program medical device for pediatric amblyopia (unapproved) in a peer-reviewed academic journal on January 21, 2026. This paper was published after undergoing peer review by experts and being approved. This study is progressing in accordance with this protocol.

About Recruitment of Participants

Currently, in collaboration with multiple medical institutions, we are moving forward with efforts to conduct a specific clinical study regarding the efficacy of the VR-based training program medical device for pediatric amblyopia (unapproved).

As of February 1, 2026, we have started recruiting study participants targeting amblyopia patients who are currently visiting the Department of Ophthalmology at Toho University Omori Medical Center. If you are considering participating in the study, please consult the physician in charge of our department.

We will continue to sequentially start recruiting participants at medical institutions that have obtained implementation approval.

▪️About the Paper

Title: Virtual Reality–Based Program for Pediatric Patients With Amblyopia: Protocol for a Multicenter, Randomized, Open-Label, Two-Arm Study

Authors: Ken Nagino1,2,3,4, Yuichi Okumura2,3,4, Masakazu Hirota3,5,6,7, Saiko Matsumura8, Nao Matsumoto8, Takashi Negishi4, Akie Midorikawa-Inomata1,2,3, Makiko Ui9, Takao Hayashi5,6, Hiroshi Hori8, Shintaro Nakao4, Takenori Inomata1,2,3,4

Author Affiliations: 1 Department of Hospital Administration, Juntendo University Graduate School of Medicine, 2 Department of Telemedicine and Mobile Health Research and Development, Juntendo University Graduate School of Medicine, 3 InnoJin Inc., 4 Department of Ophthalmology, Juntendo University Graduate School of Medicine, 5 Department of Orthoptics, Faculty of Medical Technology, Teikyo University, 6 Department of Ophthalmology, Teikyo University School of Medicine, 7 Graduate School of Medical Data Science, Teikyo University, 8 Department of Ophthalmology, Toho University School of Medicine, 9 CS Eye Clinic

Journal: JMIR Research Protocols

URL: https://www.researchprotocols.org/2026/1/e85194/

DOI: 10.2196/85194

InnoJin Inc. will continue to work on the research and development of innovative medical solutions toward realizing "a society where all children can grow up without carrying any visual handicaps."

Press Release Article

https://prtimes.jp/main/html/rd/p/000000067.000088821.html