期刊
BRITISH JOURNAL OF OPHTHALMOLOGY
卷 107, 期 4, 页码 518-524出版社
BMJ PUBLISHING GROUP
DOI: 10.1136/bjophthalmol-2021-320023
关键词
glaucoma; intraocular pressure; treatment surgery
The aim of this study was to evaluate the safety and performance of a telemetric suprachoroidal intraocular pressure (IOP) sensor (EYEMATE-SC) in patients with open angle glaucoma (OAG) undergoing non-penetrating glaucoma surgery (NPGS), and to assess the agreement between its IOP measurements and Goldmann applanation tonometry (GAT). The results showed that the EYEMATE-SC sensor was safe and well tolerated after 6 months, and demonstrated good agreement with GAT measurements.
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 1.31mm Hg (lower limit of agreement (LoA) 7.55mm Hg; upper LoA -4.92mm Hg). The maximum difference of 2.5mm Hg 3.96 (LoA 0.30-2.29) was reached on day 10 and continuously improved to an agreement of -0.15mm Hg 2.28 (LoA -1.24 to 0.89) after 6 months. Accordingly, the percentage of eyes within an IOP difference of +/- 5mm Hg improved from 78% (day 3) to 100% (6 months). Conclusions After 6months, the EYEMATE-SC sensor was safe and well tolerated, and allowed continual IOP monitoring. Trial registration number NCT03756662.
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