Safety and performance of a suprachoroidal sensor for telemetric measurement of intraocular pressure in the EYEMATE-SC trial.

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). 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'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). 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 -4.92 mm Hg). The maximum difference of 2.5 mm Hg ±3.96 (LoA 0.30-2.29) was reached on day 10 and continuously improved to an agreement of -0.15 mm Hg ±2.28 (LoA -1.24 to 0.89) after 6 months. Accordingly, the percentage of eyes within an IOP difference of ±5 mm Hg improved from 78% (day 3) to 100% (6 months). After 6 months, the EYEMATE-SC sensor was safe and well tolerated, and allowed continual IOP monitoring. NCT03756662.

Informations de copyright

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: PS has a pending international patent for the EYEMATE-SC system (PCT/EP2015/062976). EMH reports grants from Allergan, Novartis, Heidelberg Engineering, Santen, Thea outside the submitted work; KM reports grants from Implandata (C) and non-related financial disclosures from Santen (C), Fabrinal (C), Alcon (S), Allergan (S), Optovue (S); New World Medical (C), Oertli (C) MM reports grants from Implandata (C) and non-related financial disclosures from Acufocus, Allergan, Bausch and Lomb, Bayer, DORC, Heidelberg Engineering, Iridex, Novartis, Oculus, Optos, Roche, Santen, Topcon, Zeiss. HLR reports consulting fees from Santen and Allergan and research support from Carl Zeiss Meditec.