Long-term follow-up after implantation of a telemetric intraocular pressure sensor in patients with glaucoma: a safety report
| Autor: | Peter Walter, Niklas Plange, Gernot Roessler, Antonis Koutsonas |
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| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
Intraocular pressure genetic structures Long term follow up business.industry medicine.medical_treatment Glaucoma Cataract surgery medicine.disease eye diseases Clinical trial 03 medical and health sciences Ophthalmology 0302 clinical medicine Tolerability 030221 ophthalmology & optometry medicine In patient sense organs Adverse effect business 030217 neurology & neurosurgery |
| Zdroj: | Clinical & Experimental Ophthalmology. 46:473-479 |
| ISSN: | 1442-6404 |
| DOI: | 10.1111/ceo.13100 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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