Telemetric Intraocular Pressure Monitoring after Boston Keratoprosthesis Surgery Using the Eyemate-IO Sensor: Dynamics in the First Year

Abstract

To analyze the dynamics of telemetrically measured intraocular pressure (IOP) during the first year after implantation of a Boston keratoprosthesis type I (BI-KPro) cornea and to compare agreement of telemetric IOP measurements with finger palpations. Prospective, open-label, multicenter, single-arm clinical trial. In the ARGOS (NCT02945176) study, 12 individuals underwent implantation of an Eyemate-IO intraocular system. Follow-up after surgery took place 12months later with 13 visits planned per patient. During BI-KPro surgery, an electromagnetic induction sensor ring enabling telemetric IOP data transfer to a hand-held reading device outside the eye was implanted into the ciliary sulcus with or without trans-scleral suture fixation. Comprehensive ophthalmic examinations and IOP assessments through the telemetric system were compared to IOP assessed by finger palpation by 2 experts. Preoperative IOP measured by Goldmann tonometry was 13.4 ± 6.2mm Hg. Telemetric IOP peaked at 23.1 ± 16.5mm Hg at the first postoperative day. On day 5, mean IOP was 16.0 ± 5.2mm Hg and 20.95 ± 6.5mm Hg after 6-12months. IOP estimation by finger palpation was grouped in 4 categories: normal, A; soft/hypotonic, B; borderline, C; and hypertonic, D. Mean telemetric IOP was 18.2 ± 6.1mm Hg in category A, 8.9 ± 2.8mm Hg in B, 22.4 ± 4.9mm Hg in C, and 34.3 ± 11.0mm Hg in D. Differences in mean telemetric IOPs per category were statistically significant (P < .001). Daily IOP fluctuations and peaks could be identified. Telemetric IOP assessment seems to be able to identify postoperative IOP peaks and a longitudinal increase of IOP after BI-KPro surgery. IOP measurements using the telemetric Eyemate-IO sensor showed a satisfactory agreement with those of finger palpations by 2 experts.