The research paper on our in-house developed visual field analyzer, GAP, has been published in the academic journal "Ophthalmology Glaucoma" by American Academy of Ophthalmology

FINDEX Inc. (Headquarters: Chiyoda-ku, Tokyo, President and CEO: Teruo Aibara) is pleased to announce that the results of our joint research with Kyoto University's Department of Ophthalmology have been published online in the “Ophthalmology Glaucoma” journal of the American Academy of Ophthalmology at 09:00am on May 30, 2024 (local time).

Announcement of Publication of a Research Paper on the In-house Developed Gaze Analyzing Perimeter GAP, and Our Related Initiatives

Overview and Background

In this study, the research group of Professor Akitaka Tsujikawa and Specific Senior Lecturer Masahiro Miyake from Kyoto University Graduate School of Medicine, Department of Ophthalmology and Visual Science, and Professor Hiroshi Tamura from International Institute for Liberal Arts and Sciences, Kyoto University, Center for Innovative Research and Education in Data Science compared the results of Gaze Analyzing Perimeter (GAP), a head-mounted automatic perimeter developed based on a new measurement principle established from joint research by FINDEX and Kyoto University’s Department of Ophthalmology, with Humphrey Field Analyzer (HFA), the most commonly used automatic perimeter, to evaluate the efficiency of GAP.

According to a survey by the Japan Glaucoma Society, approximately 5% of individuals over the age of 40 have glaucoma, and 90% of these cases are undiagnosed. Visual field tests are particularly important for the diagnosis and monitoring of glaucoma. Conventional automated perimeters require the repetitive task of “continuously staring at the center of the screen during the examination and press a button whenever a target presented in the periphery is seen”. GAP, on the other hand, uses the principle that the gaze moves along a certain trajectory when the target is visible, and does not move when the target is not visible. Instead of relying on button presses, the device uses eye-tracking data to determine whether a target is seen, with the assessment made by artificial intelligence. GAP is also lightweight at 400g and eliminates the need for button presses during examinations. Its widespread adoption, not only in ophthalmology hospitals and clinics but also in various medical facilities and health check-up centers, is expected to contribute to the early detection and treatment of diseases causing visual field defects, such as glaucoma. Despite its high practicality as an automated perimeter, there have been no published studies comparing its performance with HFA until now.

Research Methods and Results

This study was conducted on patients who visited the Department of Ophthalmology at Kyoto University Hospital from December 2022 to July 2023 and underwent visual field test using the HFA. A total of 47 patients were analyzed, and the correlation coefficient between the HFA and GAP test results was 0.811, indicating a strong correlation. There was no statistically significant difference in test time. However, the tests that were completed within 200 seconds were only observed in the GAP group (23.4%), and such patients were limited to those with mild visual field defects. This suggests that the GAP is particularly effective in reducing test time for patients with mild visual field defects. Furthermore, a retrospective analysis of eye movements at tested points where there were discrepancies between the results of HFA and GAP revealed that in 70.2% of the cases, the gaze moved directly towards the target. This suggests a high likelihood that the targets were actually seen in these instances.

Impact of the Product and Our Future Plans

The GAP has been highly evaluated by ophthalmologists and medical professionals for its efficiency, convenience, and accuracy of test results since its launch in Japan in 2021. The fact that the GAP has been academically and objectively recognized as having comparable performance to the HFA and that there is a high correlation between the two test results is expected to contribute significantly to the future expansion of the GAP market. We will not only widely publicize the recent research findings but also establish a new sales framework that incorporates usability improvements, thereby enhancing our sales activities. Internationally, in addition to our existing shipments to the EU, the Middle East and North Africa, we are preparing to commence sales in India and ASEAN countries. We will continue to collaborate with medical device distributors and local agents to carry out various initiatives, including marketing, obtaining regulatory approvals, and localization efforts in each region. In addition, we are planning to expand the use of the device to various ophthalmic tests by enhancing the software, and we are also conducting further research in collaboration with university hospitals in Japan to confirm the usefulness of the GAP in the early detection of mild cognitive impairment (MCI).

The GAP is a lightweight and easy-to-use visual field testing device that can be easily implemented in health checkup facilities, home visits, and remote medical services. We believe that the widespread use of the device will lead to the early detection and treatment of visual field defects, including glaucoma, and we are committed to continuing our research and development activities to prevent as many cases of visual field defects and blindness as possible.

About the Research Project

This joint research was conducted at the following facilities:

Kyoto University Graduate School of Medicine, Department of Ophthalmology and Visual Science
Specific Senior Lecturer: Masahiro Miyake
Professor: Akitaka Tsujikawa
International Institute for Liberal Arts and Sciences, Kyoto University, Center for Innovative Research and Education in Data Science
Professor: Hiroshi Tamura
FINDEX Inc.
President and CEO: Teruo Aibara

Product brochure: https://findex.co.jp/en/products/pdf/gap_en_2206.pdf
Notification No. of medical device manufacturing and sales: 38B2X10003000002

Inquiry:

FINDEX Inc. Corporate Communications
https://findex.co.jp/inquiry/contact_us.html