PURPOSE: We investigated the safety of a telemetric IOP sensor and the accuracy of its IOP measurements in six patients with open-angle glaucoma and cataract. METHODS: The study design was a prospective, single-center clinical trial. Here we present 1-year follow-up data. A ring-shaped telemetric IOP sensor was implanted in the ciliary sulcus after implantation of the intracapsular lens, during planned cataract surgery. The sensor is encapsulated in silicone rubber and consists of a miniature device with eight pressure-sensitive capacitors and a circular microcoil antenna. IOP measurements are performed with a reader unit held in front of the eye. IOP is calculated as the differences between the absolute pressure inside the eye (pressure sensor) and that outside the eye (reader unit). RESULTS: The sensor was successfully implanted in all patients. Four patients developed sterile anterior chamber inflammation that resolved completely within 9 days after surgery with anti-inflammatory treatment. All patients showed mild to moderate pupillary distortion and pigment dispersion after surgery. Telemetric IOP measurement was performed in all patients at all visits, and the patients successfully performed self-tonometry at home after receiving instructions. Telemetric IOP values showed similar profiles compared to those of Goldmann applanation tonometry (GAT). Three patients showed a relevant IOP step during follow-up, and in one patient, negative values were obtained throughout the study. CONCLUSIONS: Despite early postoperative anterior chamber inflammation, the IOP sensor was well tolerated by all patients. We describe the first prospective clinical study of a noncontact IOP sensor that potentially enables continuous IOP monitoring in patients with glaucoma. The sensor shape and size needs to be adapted to avoid pupillary distortion and to confirm that IOP measurements are accurately recorded in comparison to those of GAT. ( www.germanctr.de; number DRKS00003335.). Copyright 2015 The Association for Research in Vision and Ophthalmology, Inc.
RCT Entities:
PURPOSE: We investigated the safety of a telemetric IOP sensor and the accuracy of its IOP measurements in six patients with open-angle glaucoma and cataract. METHODS: The study design was a prospective, single-center clinical trial. Here we present 1-year follow-up data. A ring-shaped telemetric IOP sensor was implanted in the ciliary sulcus after implantation of the intracapsular lens, during planned cataract surgery. The sensor is encapsulated in silicone rubber and consists of a miniature device with eight pressure-sensitive capacitors and a circular microcoil antenna. IOP measurements are performed with a reader unit held in front of the eye. IOP is calculated as the differences between the absolute pressure inside the eye (pressure sensor) and that outside the eye (reader unit). RESULTS: The sensor was successfully implanted in all patients. Four patients developed sterile anterior chamber inflammation that resolved completely within 9 days after surgery with anti-inflammatory treatment. All patients showed mild to moderate pupillary distortion and pigment dispersion after surgery. Telemetric IOP measurement was performed in all patients at all visits, and the patients successfully performed self-tonometry at home after receiving instructions. Telemetric IOP values showed similar profiles compared to those of Goldmann applanation tonometry (GAT). Three patients showed a relevant IOP step during follow-up, and in one patient, negative values were obtained throughout the study. CONCLUSIONS: Despite early postoperative anterior chamber inflammation, the IOP sensor was well tolerated by all patients. We describe the first prospective clinical study of a noncontact IOP sensor that potentially enables continuous IOP monitoring in patients with glaucoma. The sensor shape and size needs to be adapted to avoid pupillary distortion and to confirm that IOP measurements are accurately recorded in comparison to those of GAT. ( www.germanctr.de; number DRKS00003335.). Copyright 2015 The Association for Research in Vision and Ophthalmology, Inc.
Authors: Anastasios G Konstas; Malik Y Kahook; Makoto Araie; Andreas Katsanos; Luciano Quaranta; Luca Rossetti; Gábor Holló; Efstathios T Detorakis; Francesco Oddone; Dimitrios G Mikropoulos; Gordon N Dutton Journal: Adv Ther Date: 2018-10-20 Impact factor: 3.845