Lars Choritz1, Kaweh Mansouri2, Jacqueline van den Bosch3, Melanie Weigel4, H Burkhard Dick5, Markus Wagner4, Hagen Thieme4. 1. University Eye Clinic Magdeburg, Magdeburg, Germany. Electronic address: lars.choritz@med.ovgu.de. 2. Glaucoma Research Center, Montchoisi Clinic, Swiss Vision Network, Lausanne, Switzerland; Department of Ophthalmology, University of Colorado, Denver, Colorado, USA. 3. University Eye Clinic Magdeburg, Magdeburg, Germany; Implandata Ophthalmic Products GmbH, Hannover, Germany. 4. University Eye Clinic Magdeburg, Magdeburg, Germany. 5. University Eye Clinic Bochum, Bochum, Germany.
Abstract
PURPOSE: The aim of this study was to investigate the safety and performance of the second generation of an implantable intraocular pressure (IOP) sensor in patients with primary open angle glaucoma (POAG). DESIGN: prospective, noncomparative, open-label, multicenter clinical investigation. METHODS: In this study, patients with POAG, regularly scheduled for cataract surgery, were implanted with a ring-shaped, sulcus-placed, foldable IOP sensor in a single procedure after intraocular lens implantation. Surgical complications as well as adverse events (AEs) during 12 months of follow-up were recorded. At each follow-up visit, a complete ophthalmic examination, including visual acuity, IOP, slit lamp examination, and dilated funduscopy as well as comparative measurements between Goldmann applanation tonometry and the EYEMATE-IO implant were performed. RESULTS: The EYEMATE-IO implant was successfully implanted in 22 patients with few surgical complications and no unexpected device-related AEs. All ocular AEs resolved quickly under appropriate treatment. Comparative measurements showed good agreement between EYEMATE-IO and Goldmann applanation tonometry (GAT) with an intraclass correlation coefficient (ICC(3,k)) of 0.783 (95% confidence interval [CI]: 0.743, 0.817). EYEMATE-IO measurements were higher than GAT, with a mean difference of 3.2 mm Hg (95% CI: 2.8, 3.5 mm Hg). CONCLUSIONS: The EYEMATE-IO sensor was safely implanted in 22 patients and performed reliably until the end of follow-up. This device allows for continual and long-term measurements of IOP.
PURPOSE: The aim of this study was to investigate the safety and performance of the second generation of an implantable intraocular pressure (IOP) sensor in patients with primary open angle glaucoma (POAG). DESIGN: prospective, noncomparative, open-label, multicenter clinical investigation. METHODS: In this study, patients with POAG, regularly scheduled for cataract surgery, were implanted with a ring-shaped, sulcus-placed, foldable IOP sensor in a single procedure after intraocular lens implantation. Surgical complications as well as adverse events (AEs) during 12 months of follow-up were recorded. At each follow-up visit, a complete ophthalmic examination, including visual acuity, IOP, slit lamp examination, and dilated funduscopy as well as comparative measurements between Goldmann applanation tonometry and the EYEMATE-IO implant were performed. RESULTS: The EYEMATE-IO implant was successfully implanted in 22 patients with few surgical complications and no unexpected device-related AEs. All ocular AEs resolved quickly under appropriate treatment. Comparative measurements showed good agreement between EYEMATE-IO and Goldmann applanation tonometry (GAT) with an intraclass correlation coefficient (ICC(3,k)) of 0.783 (95% confidence interval [CI]: 0.743, 0.817). EYEMATE-IO measurements were higher than GAT, with a mean difference of 3.2 mm Hg (95% CI: 2.8, 3.5 mm Hg). CONCLUSIONS: The EYEMATE-IO sensor was safely implanted in 22 patients and performed reliably until the end of follow-up. This device allows for continual and long-term measurements of IOP.
Authors: Jacqueline J O N van den Bosch; Vincenzo Pennisi; Azzurra Invernizzi; Kaweh Mansouri; Robert N Weinreb; Hagen Thieme; Michael B Hoffmann; Lars Choritz Journal: Invest Ophthalmol Vis Sci Date: 2021-05-03 Impact factor: 4.799
Authors: Jessica V Jasien; Ye Emma Zohner; Sonia Kuhn Asif; Lindsay A Rhodes; Brian C Samuels; Christopher A Girkin; Jeffrey S Morris; J Crawford Downs Journal: Sci Rep Date: 2020-12-01 Impact factor: 4.379