CE19 - Technologies pour la santé 2021

Laser pointer on contact lens for visually impaired people – RE-SEE

Visual rehabilitation device based on an instrumented contact lens - RE-SEE.

The RE-SEE project is a collaborative research project involving IMT Atlantique's Optics department and the SME E3S. Two subcontractors were also involved in the study: Streetlab, the Vision Institute's experimental platform based at the XV-XX hospital, and LCS Laboratoires, which supplied the instrumented contact lenses.

Project objectives

Vision restoration and visual rehabilitation could greatly benefit from eye movement analysis, but current eye-tracking solutions are not well suited to these patients. RE-SEE's objective, in this context, was to exploit the potential of a laser pointer embedded in a contact lens (CLP), recently demonstrated by IMT Atlantique. To achieve this, a collaboration was set up between IMT Atlantique, which created the concept and gave the first proof of concept, and an electronic eyewear manufacturer (Eyes3Shut). One of RE-SEE's challenges was to manufacture a CLP that was both eye-safe and comfortable to wear, so that it could be used for visual rehabilitation experiments in a healthcare environment. This meant demonstrating the use of our device as a medical device. This required us to validate a certain number of safety conditions, before enabling its use in a clinical setting, making it the first instrumented contact lens (incorporating a laser source) validated in an orthoptic rehabilitation context, with a real benefit in terms of improved eye-tracking performance. From this point of view, RE-SEE has contributed to the use of instrumented contact lenses in a healthcare environment, by familiarizing practitioners with this type of new medical device.

The implementation was carried out in several stages. First, we calibrated and compared the CLP-based gaze direction tracker with commercial eye-trackers in terms of performance, detection reliability and gaze tracking. This work was carried out on artificial eyes or prosthetic eyes. We then undertook a series of tests on the materials and components used, as well as on eye safety, so as to be able to test the comfort and acceptability of our device on a set of beta-testers. Having successfully completed this stage, we have now, in collaboration with the Vision Institute, submitted an IRB application to the XV-XX hospital for use in a healthcare environment. Given the novelty of the device, this task required numerous interactions with, in particular, the ANSM, following a timetable that we were unable to control. This led us to start the first tests at the end of the project. The protocol for these tests was drawn up in collaboration with the Streetlab, the Vision Institute experimental platform. This is a new rehabilitation protocol for visually impaired subjects, based on the eye-tracking capabilities of the CLP. This is a new rehabilitation protocol for visually impaired subjects, based on eye-tracking enabled by the CLP. It uses precise, objective measurement of the patient's performance to enable optometrists to better guide rehabilitation exercises, better understand their visual strategies and make the patient more aware of where they are looking to help them develop visual strategies. Some training protocols have also been digitized, opening up new possibilities such as home training. Our CLP and its accompanying device will thus contribute to the digital transformation of healthcare therapies

We have developed and demonstrated a complete eye tracking and analysis system based on the use of an instrumented contact lens. This is clearly a world first. We have demonstrated good performance in terms of gaze direction accuracy, but above all the greater reliability of this device and its immunity to variability in environmental illumination conditions, compared with other existing systems. We have developed a complete, self-contained, portable device that enables the wearer to be mobile (Figure below). However, to qualify as a medical device for use in a clinical environment, we had to take a number of additional steps to ensure personal safety (e.g., cytology, ocular safety, etc.), as well as making it comfortable to use for the duration of the rehabilitation tasks envisaged. These steps were successfully completed. Finally, in order to be able to use it in a healthcare environment, we had to validate a specific CPP for its use in a medical environment, which we did. This also enabled us to start familiarizing the population of its future users (orthoptists and ophthalmologists) with the use of this instrumented contact lens as a medical device

As indicated in the final report, the validation by the Comité de Protection des Personnes (CPP) has taken longer than expected, so we have barely begun testing on patients suffering from Stargardt's disease. The study will be carried out on two groups of people at Streetlab within the Vision Institute: 16 healthy sighted control subjects (visual acuity of at least 10/10th in binocular vision); 16 subjects with Stargardt's disease (visual acuity > or equal to 20/400th in binocular vision). Subjects will perform simple visual tasks (fixation, saccades and pursuit) on a projected screen, and we will measure their visual performance with the SCL lens and with a conventional eye-tracker (PupilLab). These tests should be the subject of scientific publications in journal paper and in proceedings of conference (e.g. ARVO), in the summer of 2025. At the same time, in collaboration with LCS Laboratoires, we have begun thinning our contact lenses to make them optically neutral. Finally, we are also integrating a laser beam collimation device to enable the laser pointer to be materialized on a surface at a distance of between 40 and 80 cm, which should be the subject of a publication. This option will also considerably improve the performance and computing time of the current device.

The project has resulted in four scientific publications in A-ranked journals, one conference (see list above), and the award of a CPP for the use of our device in a healthcare environment. In addition, RE-SEE has directly or indirectly enabled the completion of two doctoral theses (M. Otheguy, F-M. Robert) and the recruitment of a post-doctoral student (A. Rakotoarivelo), in collaboration with industrial partner E3S.

Vision restoration and vision rehabilitation could strongly benefit from eye motion analysis and monitoring but current eyetracking solutions are not well suited to these patients. The RE-SEE project aims to harness the potential for such uses of a contact lens laser pointer (CLP) recently demonstrated by IMT Atlantic. To achieve this objective, a collaboration has been set up between the academic partner (IMT Atlantique) who created the concept of the first prototype and the manufacturer of electronic glasses (E3S) which has already produced the remote control device for this lens. Tests will be performed on a representative sample of visually impaired patients. For this, we will call on the Streetlab of the Institut de la Vision, which has the necessary environment for these tests to be carried out successfully in compliance with ethical and healthcare regulations. A CE marking protocol for the contact lens will be initiated to allow patient testing during the second half of the project. In order to control the cost and the schedule of this certification, the partners will call on the company LCS, manufacturer of lenses, which has already carried out the CE marking of an instrumented contact lenses in the past. In this context, Re-SEE will focus on three main WP aimed at guaranteeing the manufacture of a safe and comfortable CLP (WP1); to develop the associated middleware necessary for the envisaged uses (WP2); and to validate, in a clinical context (Streetlab), the benefit of CLP compared to other eye monitoring solutions (WP3) in the context of visual rehabilitation and for a few cases of vision restoration (in connection with the treatment of hereditary optic neuropathies proposed by Gensight-Biologics). Beyond the obvious benefits for vision restoration and visual rehabilitation, RE-SEE will contribute to the development of new wearable devices to improve healthcare.

Project coordination

Jean-Louis De Bougrenet De La Tocnaye (Ecole Nationale Supérieure Mines-Télécom Atlantique Bretagne Pays de la Loire)

The author of this summary is the project coordinator, who is responsible for the content of this summary. The ANR declines any responsibility as for its contents.

Partnership

IMT Atlantique Ecole Nationale Supérieure Mines-Télécom Atlantique Bretagne Pays de la Loire
E3S EYES TRIPLE SHUT / R&D

Help of the ANR 407,173 euros
Beginning and duration of the scientific project: February 2022 - 36 Months

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