Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study.

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.