Ophthalmology · 2025
Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Micheletti Eleonora, Mansouri Kaweh, Dick H Burkhard, Hoffmann Esther M, Mackert Marc J, Weinreb Robert N, Szurman Peter, EYEMATE-SC Study Group
Аннотация
PURPOSE: To evaluate the long-term safety and performance of the EYEMATE-SC sensor system, a suprachoroidal implantable diagnostic medical device designed for measuring intraocular pressure (IOP) in patients with glaucoma that offers direct digitized IOP readings in millimeters of mercury.
DESIGN: This study is part of the prospective, open-label, multicenter interventional EYEMATE-SC trial.
PARTICIPANTS: Twenty-two eyes of 22 patients with open-angle glaucoma who received the implant in conjunction with nonpenetrating glaucoma surgery (NPGS) were included in the study.
METHODS: This 3-year follow-up study analyzed the long-term safety of the EYEMATE-SC suprachoroidal sensor system (Implandata). The telemetric sensor system includes an implantable IOP sensor and a handheld reading device.
MAIN OUTCOME MEASURES: All patients underwent 5 follow-up visits over a 24-month follow-up period from month 12 to month 36 after implantation. Each visit consisted of a comprehensive examination including IOP measurement with the EYEMATE-SC system and Goldmann applanation tonometry (GAT). The agreement between GAT and the EYEMATE-SC was analyzed using Bland-Altman analysis. Adverse events (AEs) and device-related adverse events (ADEs) were recorded at all follow-up visits.
RESULTS: Of 24 eligible patients of the EYEMATE-SC trial, 22 patients (mean age 65.0 ± 10.6 years, 54.5% female) were enrolled. The overall mean follow-up was 2.7 ± 0.6 years (range, 1.0-3.4 years). Limits of agreement between GAT and EYEMATE-SC IOP were -6.2 to 5.7 mmHg (mean absolute difference of 2.3 mmHg), with greatest concordance at 12 months (concordance correlation coefficient [rccc] = 0.802, N = 22) and 18 months (rccc = 0.854, N = 19). A difference of < 5 mmHg was recorded in > 85% of the 86 paired measurements. No serious AEs and ADEs were recorded. Most common AEs were raised IOP in 5 patients, reduced visual acuity in 3 patients, and cataract in 3 patients.
CONCLUSIONS: This study demonstrates the long-term safety of the EYEMATE-SC system. No serious AEs related to the EYEMATE-SC were observed. The agreement between the EYEMATE-SC and GAT was within the standard range of IOP-measuring methods set by regulatory agencies. The EYEMATE-SC system is well tolerated and accurate for self- measurement of IOP throughout the day.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
DESIGN: This study is part of the prospective, open-label, multicenter interventional EYEMATE-SC trial.
PARTICIPANTS: Twenty-two eyes of 22 patients with open-angle glaucoma who received the implant in conjunction with nonpenetrating glaucoma surgery (NPGS) were included in the study.
METHODS: This 3-year follow-up study analyzed the long-term safety of the EYEMATE-SC suprachoroidal sensor system (Implandata). The telemetric sensor system includes an implantable IOP sensor and a handheld reading device.
MAIN OUTCOME MEASURES: All patients underwent 5 follow-up visits over a 24-month follow-up period from month 12 to month 36 after implantation. Each visit consisted of a comprehensive examination including IOP measurement with the EYEMATE-SC system and Goldmann applanation tonometry (GAT). The agreement between GAT and the EYEMATE-SC was analyzed using Bland-Altman analysis. Adverse events (AEs) and device-related adverse events (ADEs) were recorded at all follow-up visits.
RESULTS: Of 24 eligible patients of the EYEMATE-SC trial, 22 patients (mean age 65.0 ± 10.6 years, 54.5% female) were enrolled. The overall mean follow-up was 2.7 ± 0.6 years (range, 1.0-3.4 years). Limits of agreement between GAT and EYEMATE-SC IOP were -6.2 to 5.7 mmHg (mean absolute difference of 2.3 mmHg), with greatest concordance at 12 months (concordance correlation coefficient [rccc] = 0.802, N = 22) and 18 months (rccc = 0.854, N = 19). A difference of < 5 mmHg was recorded in > 85% of the 86 paired measurements. No serious AEs and ADEs were recorded. Most common AEs were raised IOP in 5 patients, reduced visual acuity in 3 patients, and cataract in 3 patients.
CONCLUSIONS: This study demonstrates the long-term safety of the EYEMATE-SC system. No serious AEs related to the EYEMATE-SC were observed. The agreement between the EYEMATE-SC and GAT was within the standard range of IOP-measuring methods set by regulatory agencies. The EYEMATE-SC system is well tolerated and accurate for self- measurement of IOP throughout the day.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.