EYEMATE-SC Trial: Twelve-Month Safety, Performance, and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure

Peter Szurman; Kevin Gillmann; Anna-Maria Seuthe; H Burkhard Dick; Esther M Hoffmann; Andre Mermoud; Marc J Mackert; Robert N Weinreb; Harsha L Rao; Kaweh Mansouri; EYEMATE-SC Study Group

doi:10.1016/j.ophtha.2022.09.021

EYEMATE-SC Trial: Twelve-Month Safety, Performance, and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure

Ophthalmology. 2023 Mar;130(3):304-312. doi: 10.1016/j.ophtha.2022.09.021. Epub 2022 Oct 3.

Authors

Collaborators

Affiliations

¹ Eye Clinic Sulzbach, Knappschaft Hospital Saar, Sulzbach, Germany; Klaus Heimann Eye Research Institute, Sulzbach, Germany.
² Glaucoma Research Center, Montchoisi Clinic, Swiss Visio, Lausanne, Switzerland; Glaucoma Services, Moorfields Eye Hospital, London, United Kingdom; Department of Ophthalmology, Byers Eye Institute, Stanford University, Palo Alto, California.
³ Eye Clinic Sulzbach, Knappschaft Hospital Saar, Sulzbach, Germany.
⁴ University Eye Clinic Bochum, Bochum, Germany.
⁵ Department of Ophthalmology, University Medical Center, Mainz, Germany.
⁶ Glaucoma Research Center, Montchoisi Clinic, Swiss Visio, Lausanne, Switzerland.
⁷ Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany.
⁸ Hamilton Glaucoma Center, Shiley Eye Institute, and the Viterbi Department of Ophthalmology, University of California, San Diego, La Jolla, California.
⁹ Narayana Nethralaya, Bangalore, India; University Eye Clinic Maastricht, University Medical Center, Maastricht, the Netherlands.
¹⁰ Glaucoma Research Center, Montchoisi Clinic, Swiss Visio, Lausanne, Switzerland. Electronic address: kwmansouri@gmail.com.

PMID: 36202141
DOI: 10.1016/j.ophtha.2022.09.021

Abstract

Purpose: Measuring and controlling intraocular pressure (IOP) provide the foundation for glaucoma treatment. Self-tonometry has been proposed as an alternative to measure IOP throughout the entire day better. The novel EYEMATE-SC sensor (Implandata) is implanted in the suprachoroidal space to enable contactless continual IOP monitoring. The aim of the present study was to investigate the 1-year safety, performance, and accuracy of the EYEMATE-SC in patients with primary open-angle glaucoma undergoing simultaneous nonpenetrating glaucoma surgery (NPGS).

Design: Prospective, multicenter, open-label, single-arm, interventional clinical trial.

Participants: Twenty-four eyes of 24 patients with primary open-angle glaucoma who were due to undergo NPGS (canaloplasty or deep sclerectomy).

Methods: An EYEMATE-SC sensor was implanted during NPGS. Goldmann applanation tonometry (GAT) measurements were compared with the sensors' IOP measurements at all postoperative visits through 12 months.

Main outcome measures: Device position and adverse events.

Results: Fifteen eyes underwent canaloplasty, and 9 underwent deep sclerectomy. Successful implantation of the sensor was achieved in all eyes with no reported intraoperative difficulties. Through the 12-month follow-up, no device migration, dislocation, or serious device-related complications were recorded. A total of 536 EYEMATE-SC measurements were pairwise included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 0.8 mmHg (95% confidence interval [CI] of the limits of agreement [LoA], -5.1 to 6.7 mmHg). The agreement gradually improved, and from 3 months after surgery until the end of the follow-up, the mean difference was -0.2 mmHg (95% CI of LoA, -4.6 to 4.2 mmHg) over a total of 264 EYEMATE-SC measurements, and 100% of measurements were within ±5 mmHg of GAT.

Conclusions: The EYEMATE-SC sensor was safe and well tolerated through 12 months. Moreover, it allowed accurate, continuous IOP monitoring.

Financial disclosure(s): Proprietary or commercial disclosure may be found after the references.

Keywords: Glaucoma; IOP; Implantable; Self-tonometry; Telemetry.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Glaucoma, Open-Angle*
Humans
Intraocular Pressure*
Prospective Studies
Reproducibility of Results
Tonometry, Ocular

Substances

N-palmitoylgalactosylsphingosine