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

Peter Szurman; Kaweh Mansouri; H Burkhard Dick; Andre Mermoud; Esther M Hoffmann; Marc Mackert; Robert N Weinreb; Harsha Laxmana Rao; Anna-Maria Seuthe; EYEMATE-SC study group

doi:10.1136/bjophthalmol-2021-320023

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

Peter Szurman^*, Kaweh Mansouri, H Burkhard Dick, Andre Mermoud, Esther M Hoffmann, Marc Mackert, Robert N Weinreb, Harsha Laxmana Rao, Anna-Maria Seuthe, EYEMATE-SC study group

^*Corresponding author for this work

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

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'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 -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).

CONCLUSIONS: After 6 months, the EYEMATE-SC sensor was safe and well tolerated, and allowed continual IOP monitoring.

TRIAL REGISTRATION NUMBER: NCT03756662.

Original language	English
Article number	bjophthalmol-2021-320023
Pages (from-to)	518-524
Number of pages	7
Journal	British Journal of Ophthalmology
Volume	107
Issue number	4
Early online date	12 Nov 2021
DOIs	https://doi.org/10.1136/bjophthalmol-2021-320023
Publication status	Published - Apr 2023

Keywords

CANALOPLASTY
DRAINAGE
DYNAMIC CONTOUR TONOMETRY
GLAUCOMA
GOLDMANN APPLANATION TONOMETRY
HEALTHY
IMPLANTATION
TERM
glaucoma
intraocular pressure
treatment surgery

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Szurman, P., Mansouri, K., Dick, H. B., Mermoud, A., Hoffmann, E. M., Mackert, M., Weinreb, R. N., Rao, H. L., Seuthe, A.-M., & EYEMATE-SC study group (2023). Safety and performance of a suprachoroidal sensor for telemetric measurement of intraocular pressure in the EYEMATE-SC trial. British Journal of Ophthalmology, 107(4), 518-524. Article bjophthalmol-2021-320023. https://doi.org/10.1136/bjophthalmol-2021-320023

@article{28e221406b36423498fde2f90235c094,

title = "Safety and performance of a suprachoroidal sensor for telemetric measurement of intraocular pressure in the EYEMATE-SC trial",

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'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 -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).CONCLUSIONS: After 6 months, the EYEMATE-SC sensor was safe and well tolerated, and allowed continual IOP monitoring.TRIAL REGISTRATION NUMBER: NCT03756662.",

keywords = "CANALOPLASTY, DRAINAGE, DYNAMIC CONTOUR TONOMETRY, GLAUCOMA, GOLDMANN APPLANATION TONOMETRY, HEALTHY, IMPLANTATION, TERM, glaucoma, intraocular pressure, treatment surgery",

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

note = "{\textcopyright} Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2023",

month = apr,

doi = "10.1136/bjophthalmol-2021-320023",

language = "English",

volume = "107",

pages = "518--524",

journal = "British Journal of Ophthalmology",

issn = "0007-1161",

publisher = "BMJ Publishing Group",

number = "4",

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Szurman, P, Mansouri, K, Dick, HB, Mermoud, A, Hoffmann, EM, Mackert, M, Weinreb, RN, Rao, HL, Seuthe, A-M & EYEMATE-SC study group 2023, 'Safety and performance of a suprachoroidal sensor for telemetric measurement of intraocular pressure in the EYEMATE-SC trial', British Journal of Ophthalmology, vol. 107, no. 4, bjophthalmol-2021-320023, pp. 518-524. https://doi.org/10.1136/bjophthalmol-2021-320023

TY - JOUR

T1 - Safety and performance of a suprachoroidal sensor for telemetric measurement of intraocular pressure in the EYEMATE-SC trial

AU - Szurman, Peter

AU - Mansouri, Kaweh

AU - Dick, H Burkhard

AU - Mermoud, Andre

AU - Hoffmann, Esther M

AU - Mackert, Marc

AU - Weinreb, Robert N

AU - Rao, Harsha Laxmana

AU - Seuthe, Anna-Maria

AU - EYEMATE-SC study group

N1 - © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2023/4

Y1 - 2023/4

N2 - 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'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 -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).CONCLUSIONS: After 6 months, the EYEMATE-SC sensor was safe and well tolerated, and allowed continual IOP monitoring.TRIAL REGISTRATION NUMBER: NCT03756662.

AB - 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'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 -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).CONCLUSIONS: After 6 months, the EYEMATE-SC sensor was safe and well tolerated, and allowed continual IOP monitoring.TRIAL REGISTRATION NUMBER: NCT03756662.

KW - CANALOPLASTY

KW - DRAINAGE

KW - DYNAMIC CONTOUR TONOMETRY

KW - GLAUCOMA

KW - GOLDMANN APPLANATION TONOMETRY

KW - HEALTHY

KW - IMPLANTATION

KW - TERM

KW - glaucoma

KW - intraocular pressure

KW - treatment surgery

U2 - 10.1136/bjophthalmol-2021-320023

DO - 10.1136/bjophthalmol-2021-320023

M3 - Article

C2 - 34772665

SN - 0007-1161

VL - 107

SP - 518

EP - 524

JO - British Journal of Ophthalmology

JF - British Journal of Ophthalmology

IS - 4

M1 - bjophthalmol-2021-320023

ER -

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

Abstract

Keywords

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