Purpose

To evaluate in glaucoma patients the feasibility and use of remote monitoring of intraocular pressure (IOP) with an implanted telemetry sensor during the coronavirus disease 2019 (COVID-19) lockdown.

Design

Cross-sectional study.

Participants

Patients previously implanted with a telemetric IOP sensor (Eyemate; Implandata GmbH) were included.

Methods

Intraocular pressure measurements acquired by the patients during the lockdown were collected by physicians who were located remotely. A questionnaire was sent to 10 participating study centers to evaluate the clinical impact of remote monitoring of IOP via the IOP sensor system.

Main outcome measures

Number of patients who obtained home IOP measurements.

Results

Data were available from all centers and from 37 eyes of 37 patients (16 patients with a sulcus-based sensor and 21 patients with a suprachoroidal sensor). Thirty-four patients obtained IOP measurements during the lockdown. Mean age of the patients was 69.3 ± 9.6 years, and 48.6% were women. A total of 8415 IOP measurements from 370 measurement days were obtained. Based on remote IOP measurements, treatment was changed in 5 patients. In another 5 patients, treatment change was considered when physicians received the IOP measurements after the lockdown. Nine of the 10 study centers judged remote IOP measurements to have a clinical impact.

Conclusions

These results show the feasibility of patient-acquired measurement of IOP in conjunction with remote IOP monitoring by physicians with an implantable sensor. The data obtained impacted clinical decision making, including adjustment of ocular hypotensive therapy and avoiding unnecessary office visits during the COVID-19 pandemic.

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.