– TIL002 shows a high level of convergence between visual acuity measurements obtained at home with OdySight® and standard clinical tests.
– Regular monitoring of visual acuity at home with OdySight® could be more beneficial than occasional measurements during consultations, because of the variability of visual acuity.
– TIL002 strengthens OdySight®’s position as a pioneering tool for vision monitoring and opens up international expansion opportunities in Europe and the United States.
PARIS–(BUSINESS WIRE)–Tilak Healthcare, a leader in the field of digital health solutions for monitoring chronic ophthalmic diseases, announces positive results from its TIL002 clinical trial aimed at validating the OdySight® mobile app as a tool allowing patients to measure their visual acuity at home by themselves. The study showed a high level of convergence between at-home evaluations of visual acuity measured with OdySight® and standard methods used during consultations, showing the solution’s reliability.
OdySight® is a prescription-only CE-marked medical device available on smartphones and tablets that allows patients with chronic macular degeneration to carry out regular monitoring of their visual acuity through eye tests that they perform themselves. Results are sent automatically to their physicians along with notifications when a deterioration in vision is detected, making it easier to carry out personalized monitoring between appointments and arrange urgent medical intervention where necessary.
TIL002 is a prospective multi-center clinical study whose main objective is to assess the equivalence of visual acuity measurements carried out at a distance of 40 cm by patients themselves in their homes using OdySight® and those obtained using standard methods during consultations. The study looked at 58 patients and 105 eyes, and took place over a period of one and a half years across three centers in France (the Hôpital National des 15-20 in Paris, the Centre Ophtalmologique Rabelais in Lyon and the Institut Ophtalmologique de l’Ouest Clinique Jules Vernes in Nantes). Patients were monitored through two visits, one to three months apart, and OdySight® measurements were also taken, particularly between visits.
Statistical analysis was carried out on 89 eyes for which an Odysight® test was carried out on the same day as a standard ETDRS test during a consultation. The results showed a high level of concordance between the two methods, with an average difference of 0.33 letters, and 82% of OdySight® measurements showed a maximum difference of 9 letters compared with the result of the standard test.
Dr. Jean-François Girmens, ophthalmologist at the Hôpital des 15-20 in Paris and Medical Director and co-founder of Tilak Healthcare, said: “Chronic macular diseases such as AMD are on the rise with population aging, but new anti-VEGF treatments are significantly improving quality of life by spacing out injections by up to four months. A tool that allows monitoring between consultations and that patients can use easily and without assistance is paramount to facilitate the swift and safe adoption of these new drugs. TIL002 marks a key step in the clinical validation of OdySight® and proves that it is a reliable way for patients to monitor their visual acuity by themselves at home. In addition, given the variability of visual acuity measurements, having a large number of results from regular home tests could prove more helpful than occasional measurements performed during consultations taking place a long time apart.”
About Tilak Healthcare
Tilak Healthcare is a pioneer and leader in the field of digital healthcare. It combines strong expertise in ophthalmology with know-how in the field of video games in order to optimize support and monitoring for chronic vision disorders. OdySight®, its first mobile app, targets macular diseases – i.e., diseases involving the degeneration of the retina – which are becoming much more common and are the world’s leading cause of blindness. Odysight®, available on prescription, allows patients to monitor their visual acuity themselves and allows doctors to improve their care by adjusting treatments according to notifications they receive about changes in the patient’s visual acuity. Since May 2022, OdySight® has been part of the French Article 51 framework for experimental treatment methods, and the aim is for it to qualify for standard medical expenses reimbursement in 2024. The Odysight® app has already been prescribed to more than 15,000 patients in France by more than 900 ophthalmologists, particularly through a joint promotion partnership with Laboratoires Théa. Tilak Healthcare was founded in 2016 as part of the Ibionext ecosystem by Professor José-Alain Sahel and Édouard Gasser (formerly of Gameloft).