Telemetric Intraocular Pressure Monitoring after Boston Keratoprosthesis Surgery Using the Eyemate-IO Sensor: Dynamics in the First Year

Am J Ophthalmol. 2019 Oct;206:256-263. doi: 10.1016/j.ajo.2019.02.025. Epub 2019 Mar 5.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Artificial Organs / adverse effects*
  • Corneal Diseases / physiopathology
  • Corneal Diseases / surgery*
  • Female
  • Follow-Up Studies
  • Glaucoma / diagnosis*
  • Glaucoma / etiology
  • Glaucoma / physiopathology
  • Humans
  • Intraocular Pressure / physiology*
  • Male
  • Middle Aged
  • Ophthalmologic Surgical Procedures / adverse effects*
  • Postoperative Complications
  • Prospective Studies
  • Reproducibility of Results
  • Telemetry / methods*
  • Tonometry, Ocular / methods*
  • Visual Acuity
  • Young Adult