PMID- 31545953
OWN - NLM
STAT- MEDLINE
DCOM- 20200417
LR  - 20200417
IS  - 1879-1891 (Electronic)
IS  - 0002-9394 (Linking)
VI  - 209
DP  - 2020 Jan
TI  - Telemetric Measurement of Intraocular Pressure via an Implantable Pressure 
      Sensor-12-Month Results from the ARGOS-02 Trial.
PG  - 187-196
LID - S0002-9394(19)30469-6 [pii]
LID - 10.1016/j.ajo.2019.09.011 [doi]
AB  - 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.
CI  - Copyright (c) 2019 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Choritz, Lars
AU  - Choritz L
AD  - University Eye Clinic Magdeburg, Magdeburg, Germany. Electronic address: 
      lars.choritz@med.ovgu.de.
FAU - Mansouri, Kaweh
AU  - Mansouri K
AD  - Glaucoma Research Center, Montchoisi Clinic, Swiss Vision Network, Lausanne, 
      Switzerland; Department of Ophthalmology, University of Colorado, Denver, 
      Colorado, USA.
FAU - van den Bosch, Jacqueline
AU  - van den Bosch J
AD  - University Eye Clinic Magdeburg, Magdeburg, Germany; Implandata Ophthalmic 
      Products GmbH, Hannover, Germany.
FAU - Weigel, Melanie
AU  - Weigel M
AD  - University Eye Clinic Magdeburg, Magdeburg, Germany.
FAU - Dick, H Burkhard
AU  - Dick HB
AD  - University Eye Clinic Bochum, Bochum, Germany.
FAU - Wagner, Markus
AU  - Wagner M
AD  - University Eye Clinic Magdeburg, Magdeburg, Germany.
FAU - Thieme, Hagen
AU  - Thieme H
AD  - University Eye Clinic Magdeburg, Magdeburg, Germany.
CN  - ARGOS study group
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190920
PL  - United States
TA  - Am J Ophthalmol
JT  - American journal of ophthalmology
JID - 0370500
SB  - IM
MH  - Aged
MH  - Biosensing Techniques/*instrumentation
MH  - Electrodes, Implanted
MH  - Equipment Design
MH  - Female
MH  - Glaucoma, Open-Angle/*diagnosis/physiopathology
MH  - Humans
MH  - Intraocular Pressure/*physiology
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Telemetry/*methods
MH  - Tonometry, Ocular/*instrumentation
MH  - Visual Acuity
FIR - Thieme, Hagen
IR  - Thieme H
FIR - Rufer, Florian
IR  - Rufer F
FIR - Szurmann, Peter
IR  - Szurmann P
FIR - Wehner, Wolfram
IR  - Wehner W
FIR - Spitzer, Martin
IR  - Spitzer M
FIR - Hesse, Lutz
IR  - Hesse L
FIR - Junemann, Anselm
IR  - Junemann A
FIR - Plange, Niklas
IR  - Plange N
FIR - Schmickler, Stefanie
IR  - Schmickler S
FIR - Dick, Burkhard
IR  - Dick B
FIR - Hakan, Kaymak
IR  - Hakan K
EDAT- 2019/09/24 06:00
MHDA- 2020/04/18 06:00
CRDT- 2019/09/24 06:00
PHST- 2018/09/18 00:00 [received]
PHST- 2019/09/11 00:00 [revised]
PHST- 2019/09/12 00:00 [accepted]
PHST- 2019/09/24 06:00 [pubmed]
PHST- 2020/04/18 06:00 [medline]
PHST- 2019/09/24 06:00 [entrez]
AID - S0002-9394(19)30469-6 [pii]
AID - 10.1016/j.ajo.2019.09.011 [doi]
PST - ppublish
SO  - Am J Ophthalmol. 2020 Jan;209:187-196. doi: 10.1016/j.ajo.2019.09.011. Epub 2019 
      Sep 20.