EYEMATE-SC Trial: 12-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: 12-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

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUND: Measuring and controlling intraocular pressure (IOP) provide the foundation for glaucoma treatment. Self-tonometry has been proposed as an alternative to better measure IOP throughout the entire day. The novel EYEMATE-SC sensor 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 primary open-angle glaucoma (POAG) patients undergoing simultaneous non-penetrating glaucoma surgery (NPGS).

METHODS: In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An EYEMATE-SC sensor was implanted during NPGS. Goldmann applanation tonometry (GAT) measures were compared with the sensors' IOP measures at all post-operative visits through 12 months. Device position and adverse events were recorded throughout the follow-up.

RESULTS: 15 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 measures were pairwise included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 0.8 mmHg (limits of agreement (CI 95%, LoA): -5.1 and 6.7 mmHg). The agreement gradually improved and from 3-month post-operatively until the end of the follow-up, the mean difference was -0.2 mmHg (LoA: -4.6 and 4.2 mmHg) over a total of 264 EYEMATE-SC measures, and 100% of measures 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.

Original language	English
Pages (from-to)	304-312
Number of pages	9
Journal	Ophthalmology
Volume	130
Issue number	3
Early online date	3 Oct 2022
DOIs	https://doi.org/10.1016/j.ophtha.2022.09.021
Publication status	Published - Mar 2023

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10.1016/j.ophtha.2022.09.021

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Szurman, P., Gillmann, K., Seuthe, A.-M., Dick, H. B., Hoffmann, E. M., Mermoud, A., Mackert, M. J., Weinreb, R. N., Rao, H. L., Mansouri, K., & EYEMATE-SC study group (2023). EYEMATE-SC Trial: 12-Month Safety, Performance and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure. Ophthalmology, 130(3), 304-312. https://doi.org/10.1016/j.ophtha.2022.09.021

@article{27bfc50f4cac439caca02d3b46bc165b,

title = "EYEMATE-SC Trial: 12-Month Safety, Performance and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure",

abstract = "BACKGROUND: Measuring and controlling intraocular pressure (IOP) provide the foundation for glaucoma treatment. Self-tonometry has been proposed as an alternative to better measure IOP throughout the entire day. The novel EYEMATE-SC sensor 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 primary open-angle glaucoma (POAG) patients undergoing simultaneous non-penetrating glaucoma surgery (NPGS).METHODS: In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An EYEMATE-SC sensor was implanted during NPGS. Goldmann applanation tonometry (GAT) measures were compared with the sensors' IOP measures at all post-operative visits through 12 months. Device position and adverse events were recorded throughout the follow-up.RESULTS: 15 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 measures were pairwise included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 0.8 mmHg (limits of agreement (CI 95%, LoA): -5.1 and 6.7 mmHg). The agreement gradually improved and from 3-month post-operatively until the end of the follow-up, the mean difference was -0.2 mmHg (LoA: -4.6 and 4.2 mmHg) over a total of 264 EYEMATE-SC measures, and 100% of measures 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.",

author = "Peter Szurman and Kevin Gillmann and Anna-Maria Seuthe and Dick, {H Burkhard} and Hoffmann, {Esther M} and Andre Mermoud and Mackert, {Marc J} and Weinreb, {Robert N} and Rao, {Harsha L} and Kaweh Mansouri and {EYEMATE-SC study group}",

note = "Copyright {\textcopyright} 2022. Published by Elsevier Inc.",

year = "2023",

month = mar,

doi = "10.1016/j.ophtha.2022.09.021",

language = "English",

volume = "130",

pages = "304--312",

journal = "Ophthalmology",

issn = "0161-6420",

publisher = "Elsevier Science",

number = "3",

}

Szurman, P, Gillmann, K, Seuthe, A-M, Dick, HB, Hoffmann, EM, Mermoud, A, Mackert, MJ, Weinreb, RN, Rao, HL, Mansouri, K & EYEMATE-SC study group 2023, 'EYEMATE-SC Trial: 12-Month Safety, Performance and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure', Ophthalmology, vol. 130, no. 3, pp. 304-312. https://doi.org/10.1016/j.ophtha.2022.09.021

TY - JOUR

T1 - EYEMATE-SC Trial

T2 - 12-Month Safety, Performance and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure

AU - Szurman, Peter

AU - Gillmann, Kevin

AU - Seuthe, Anna-Maria

AU - Dick, H Burkhard

AU - Hoffmann, Esther M

AU - Mermoud, Andre

AU - Mackert, Marc J

AU - Weinreb, Robert N

AU - Rao, Harsha L

AU - Mansouri, Kaweh

AU - EYEMATE-SC study group

PY - 2023/3

Y1 - 2023/3

N2 - BACKGROUND: Measuring and controlling intraocular pressure (IOP) provide the foundation for glaucoma treatment. Self-tonometry has been proposed as an alternative to better measure IOP throughout the entire day. The novel EYEMATE-SC sensor 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 primary open-angle glaucoma (POAG) patients undergoing simultaneous non-penetrating glaucoma surgery (NPGS).METHODS: In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An EYEMATE-SC sensor was implanted during NPGS. Goldmann applanation tonometry (GAT) measures were compared with the sensors' IOP measures at all post-operative visits through 12 months. Device position and adverse events were recorded throughout the follow-up.RESULTS: 15 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 measures were pairwise included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 0.8 mmHg (limits of agreement (CI 95%, LoA): -5.1 and 6.7 mmHg). The agreement gradually improved and from 3-month post-operatively until the end of the follow-up, the mean difference was -0.2 mmHg (LoA: -4.6 and 4.2 mmHg) over a total of 264 EYEMATE-SC measures, and 100% of measures 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.

AB - BACKGROUND: Measuring and controlling intraocular pressure (IOP) provide the foundation for glaucoma treatment. Self-tonometry has been proposed as an alternative to better measure IOP throughout the entire day. The novel EYEMATE-SC sensor 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 primary open-angle glaucoma (POAG) patients undergoing simultaneous non-penetrating glaucoma surgery (NPGS).METHODS: In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An EYEMATE-SC sensor was implanted during NPGS. Goldmann applanation tonometry (GAT) measures were compared with the sensors' IOP measures at all post-operative visits through 12 months. Device position and adverse events were recorded throughout the follow-up.RESULTS: 15 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 measures were pairwise included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 0.8 mmHg (limits of agreement (CI 95%, LoA): -5.1 and 6.7 mmHg). The agreement gradually improved and from 3-month post-operatively until the end of the follow-up, the mean difference was -0.2 mmHg (LoA: -4.6 and 4.2 mmHg) over a total of 264 EYEMATE-SC measures, and 100% of measures 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.

U2 - 10.1016/j.ophtha.2022.09.021

DO - 10.1016/j.ophtha.2022.09.021

M3 - Article

C2 - 36202141

SN - 0161-6420

VL - 130

SP - 304

EP - 312

JO - Ophthalmology

JF - Ophthalmology

IS - 3

ER -