Philip Enders1, Jonathan Hall2, Marco Bornhauser2, Kaweh Mansouri3, Lebriz Altay4, Stefan Schrader5, Thomas S Dietlein4, Bjoern O Bachmann4, Thomas Neuhann2, Claus Cursiefen4. 1. Department of Ophthalmology, University Hospital of Cologne, Cologne, Germany. Electronic address: philip.enders@uk-koeln.de. 2. MVZ Prof. Neuhann mit Augenabteilung, Rotkreuzklinikum München, Munich, Germany. 3. Glaucoma Research Center, Montchoisi Clinic, Swiss Vision Network, Lausanne, Switzerland. 4. Department of Ophthalmology, University Hospital of Cologne, Cologne, Germany. 5. Department of Ophthalmology, Pius Hospital of the University of Oldenburg, Oldenburg, Germany.
Abstract
PURPOSE: To analyze the dynamics of telemetrically measured intraocular pressure (IOP) during the first year after implantation of a Boston keratoprosthesis type I (BI-KPro) cornea and to compare agreement of telemetric IOP measurements with finger palpations. DESIGN: Prospective, open-label, multicenter, single-arm clinical trial. METHODS: In the ARGOS (NCT02945176) study, 12 individuals underwent implantation of an Eyemate-IO intraocular system. Follow-up after surgery took place 12 months later with 13 visits planned per patient. During BI-KPro surgery, an electromagnetic induction sensor ring enabling telemetric IOP data transfer to a hand-held reading device outside the eye was implanted into the ciliary sulcus with or without trans-scleral suture fixation. Comprehensive ophthalmic examinations and IOP assessments through the telemetric system were compared to IOP assessed by finger palpation by 2 experts. RESULTS:Preoperative IOP measured by Goldmann tonometry was 13.4 ± 6.2 mm Hg. Telemetric IOP peaked at 23.1 ± 16.5 mm Hg at the first postoperative day. On day 5, mean IOP was 16.0 ± 5.2 mm Hg and 20.95 ± 6.5 mm Hg after 6-12 months. IOP estimation by finger palpation was grouped in 4 categories: normal, A; soft/hypotonic, B; borderline, C; and hypertonic, D. Mean telemetric IOP was 18.2 ± 6.1 mm Hg in category A, 8.9 ± 2.8 mm Hg in B, 22.4 ± 4.9 mm Hg in C, and 34.3 ± 11.0 mm Hg in D. Differences in mean telemetric IOPs per category were statistically significant (P < .001). Daily IOP fluctuations and peaks could be identified. CONCLUSIONS:Telemetric IOP assessment seems to be able to identify postoperative IOP peaks and a longitudinal increase of IOP after BI-KPro surgery. IOP measurements using the telemetric Eyemate-IO sensor showed a satisfactory agreement with those of finger palpations by 2 experts.
RCT Entities:
PURPOSE: To analyze the dynamics of telemetrically measured intraocular pressure (IOP) during the first year after implantation of a Boston keratoprosthesis type I (BI-KPro) cornea and to compare agreement of telemetric IOP measurements with finger palpations. DESIGN: Prospective, open-label, multicenter, single-arm clinical trial. METHODS: In the ARGOS (NCT02945176) study, 12 individuals underwent implantation of an Eyemate-IO intraocular system. Follow-up after surgery took place 12 months later with 13 visits planned per patient. During BI-KPro surgery, an electromagnetic induction sensor ring enabling telemetric IOP data transfer to a hand-held reading device outside the eye was implanted into the ciliary sulcus with or without trans-scleral suture fixation. Comprehensive ophthalmic examinations and IOP assessments through the telemetric system were compared to IOP assessed by finger palpation by 2 experts. RESULTS: Preoperative IOP measured by Goldmann tonometry was 13.4 ± 6.2 mm Hg. Telemetric IOP peaked at 23.1 ± 16.5 mm Hg at the first postoperative day. On day 5, mean IOP was 16.0 ± 5.2 mm Hg and 20.95 ± 6.5 mm Hg after 6-12 months. IOP estimation by finger palpation was grouped in 4 categories: normal, A; soft/hypotonic, B; borderline, C; and hypertonic, D. Mean telemetric IOP was 18.2 ± 6.1 mm Hg in category A, 8.9 ± 2.8 mm Hg in B, 22.4 ± 4.9 mm Hg in C, and 34.3 ± 11.0 mm Hg in D. Differences in mean telemetric IOPs per category were statistically significant (P < .001). Daily IOP fluctuations and peaks could be identified. CONCLUSIONS: Telemetric IOP assessment seems to be able to identify postoperative IOP peaks and a longitudinal increase of IOP after BI-KPro surgery. IOP measurements using the telemetric Eyemate-IO sensor showed a satisfactory agreement with those of finger palpations by 2 experts.