Long‐term follow‐up after implantation of a telemetric intraocular pressure sensor in patients with glaucoma: a safety report

摘要

Abstract Importance To investigate the long‐term safety of a novel intraocular telemetric pressure sensor. Background Acquisition of accurate intraocular pressure (IOP) data is vital for sufficient medical care of glaucoma patients. Non‐invasive self‐tonometry with a telemetric IOP sensor can provide important information regarding the individual IOP profile. Design Retrospective analysis of long‐term follow‐up data assessed during outpatient visits in a university hospital. Participants Six patients with open‐angle glaucoma were included. Unfortunately, one patient passed away shortly after completion of the original 1‐year study. Methods Within the scope of a prospective 1‐year pilot clinical trial, a telemetric IOP sensor was inserted into the ciliary sulcus after intracapsular lens implantation during planned cataract surgery. Patients were regularly examined as outpatients even beyond the duration of the 1‐year study. Data concerning sensor functionality, safety parameters and home self‐tonometry were assessed. Main Outcome Measures Long‐term sensor functionality and safety. Results Sensor measurements were always successful in every patient. Additionally, home self‐tonometry was conducted without any problems by every patient. The average follow‐up period was 37.5 months (21–50?months). During this period, the average number of IOP measurements performed per patient was 1273 (223–2884 measurements). No severe adverse events were reported. A varying degree of pupillary distortion was observed after 6–12?months in every patient; this remained unchanged thereafter with only one exception. Conclusions and Relevance Telemetric IOP sensors showed good functionality and tolerability during long‐term follow‐up. Non‐invasive self‐tonometry with a telemetric IOP sensor can provide useful additional data for future monitoring of patients with glaucoma.