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

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.