The multi-centre clinical trial in France revealed a notable level of convergence between at-home assessments of visual acuity conducted using the OdySight mobile app and the standard methods employed during clinical consultations
Tilak Healthcare announces positive results from TIL002 trial of OdySight App in at-home visual acuity measurement. (Credit: Karsten Paulick from Pixabay)
Tilak Healthcare has reported positive results from the TIL002 clinical trial, confirming the effectiveness of its OdySight mobile app for patients in self-measuring their visual acuity at home.
The study revealed a notable level of convergence between at-home assessments of visual acuity conducted using the OdySight mobile app and the standard methods employed during clinical consultations. This demonstrated the reliability of the solution, said the France-based digital health solutions provider.
OdySight, which is a prescription-only CE-marked medical device that is compatible with smartphones and tablets. It is designed to enable patients with chronic macular degeneration to perform self-administered eye tests for regular monitoring of their visual acuity.
The results are automatically transmitted to their physicians, accompanied by notifications indicating any detected deterioration in vision. This facilitates personalised monitoring between appointments and allows for prompt medical intervention when necessary.
The TIL002 study was a prospective multi-centre clinical trial spanning one and a half years across three centers in France. It aimed to assess the equivalence of visual acuity measurements taken by patients themselves at a distance of 40cm using OdySight in their homes compared to standard methods used during consultations.
The study involved 58 patients and 105 eyes, with two visits conducted one to three months apart, and OdySight measurements taken, particularly between visits.
Statistical analysis, based on 89 eyes that underwent both an Odysight test and a standard early treatment diabetic retinopathy study (ETDRS) test on the same day during a consultation, demonstrated a high level of concordance between the two methods.
The average difference was 0.33 letters, and 82% of OdySight measurements exhibited a maximum difference of nine letters compared to the standard test results.
Tilak Healthcare medical director and co-founder Jean-François Girmens said: “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.”