@article {Szurmanbjophthalmol-2021-320023, author = {Peter Szurman and Kaweh Mansouri and H. Burkhard Dick and Andre Mermoud and Esther M Hoffmann and Marc Mackert and Robert N Weinreb and Harsha Laxmana Rao and Anna-Maria Seuthe}, editor = {, and , and Haus, Arno and Reifschneider, Eugen and Rickmann, Annekatrin and Wakili, Philip and Emmerich, Caroline and Hoogmartens, Caroline and Lambert, Kristina and Januschowski, Kai and Elling, Matthias and Schultz, Tim and Kersten-Gomez, Inga and Lorenz, Katrin and GIers, Bert and Beck, Anna and Nobl, Matthias and Freissinger, Sigrid}, title = {Safety and performance of a suprachoroidal sensor for telemetric measurement of intraocular pressure in the EYEMATE-SC trial}, elocation-id = {bjophthalmol-2021-320023}, year = {2021}, doi = {10.1136/bjophthalmol-2021-320023}, publisher = {BMJ Publishing Group Ltd}, abstract = {Aim To investigate the safety and performance of a telemetric suprachoroidal intraocular pressure (IOP) sensor (EYEMATE-SC) and the accuracy of its IOP measurements in open angle glaucoma (OAG) patients undergoing simultaneous non-penetrating glaucoma surgery (NPGS).Methods Prospective, multicentre, open-label, single-arm, interventional clinical trial. Twenty-four eyes of 24 patients with OAG regularly scheduled for NPGS (canaloplasty or deep sclerectomy) were simultaneously implanted with an EYEMATE-SC sensor. Six-month follow-up on the sensor{\textquoteright}s safety and performance as well as on the level of agreement between the EYEMATE-SC measurements and IOP measurements with Goldmann applanation tonometry (GAT).Results The eyes underwent canaloplasty (n=15) or deep sclerectomy (n=9) and achieved successful implantation of the sensor. No device migration, dislocation or serious device-related complications occurred. A total of 367 comparisons were included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 1.31 mm Hg (lower limit of agreement (LoA) 7.55 mm Hg; upper LoA {\textendash}4.92 mm Hg). The maximum difference of 2.5 mm Hg {\textpm}3.96 (LoA 0.30{\textendash}2.29) was reached on day 10 and continuously improved to an agreement of {\textendash}0.15 mm Hg {\textpm}2.28 (LoA {\textendash}1.24 to 0.89) after 6 months. Accordingly, the percentage of eyes within an IOP difference of {\textpm}5 mm Hg improved from 78\% (day 3) to 100\% (6 months).Conclusions After 6 months, the EYEMATE-SC sensor was safe and well tolerated, and allowed continual IOP monitoring.Trial registration number NCT03756662.Data may be obtained from a third party and are not publicly available. Not applicable.}, issn = {0007-1161}, URL = {https://bjo.bmj.com/content/early/2021/11/11/bjophthalmol-2021-320023}, eprint = {https://bjo.bmj.com/content/early/2021/11/11/bjophthalmol-2021-320023.full.pdf}, journal = {British Journal of Ophthalmology} }