PMID- 36137526
OWN - NLM
STAT- MEDLINE
DCOM- 20231225
LR  - 20231225
IS  - 1423-0259 (Electronic)
IS  - 0030-3747 (Linking)
VI  - 66
IP  - 1
DP  - 2023
TI  - A 2-Year, Single-Center Study to Assess the Safety and Effectiveness of the 
      MicroShunt in Primary Open-Angle Glaucoma.
PG  - 206-217
LID - 10.1159/000526960 [doi]
AB  - AIM: The aim of the study was to assess the effectiveness and safety of the 
      MicroShunt (formerly known as the MIDI-Arrow or InnFocus MicroShunt(R)), an 
      8.5-mm-long, 70-mum lumen-controlled ab externo glaucoma filtration surgery device 
      made from poly(styrene-block-isobutylene-block-styrene) (SIBS), in patients with 
      primary open-angle glaucoma (POAG). METHODS: A 2-year, single-center, 
      single-surgeon, nonrandomized, adaptive feasibility clinical study (NCT01563237) 
      was conducted in France from June 2011 to November 2016. Eligible patients were 
      aged 18-85 years and had POAG inadequately controlled on maximum tolerated 
      medical therapy with intraocular pressure (IOP) >/=18 and </=40 mm Hg. The MicroShunt 
      was implanted ab externo with adjunctive use of mitomycin C (0.2-0.4 mg/mL 
      applied for 2-3 min), alone or in combination with cataract surgery. The primary 
      effectiveness endpoints were the reduction in IOP relative to the preoperative 
      value assessed at each postoperative visit and the measurement of success at 
      years 1 and 2. The primary safety endpoint was the incidence of all procedure- 
      and/or device-related adverse events (AEs) during the study. The secondary 
      effectiveness endpoint was the mean number of glaucoma medications per patient, 
      and the secondary safety endpoint was the incidence of glaucoma reoperation. 
      RESULTS: Sixty-one eyes from 61 patients underwent MicroShunt implantation. Mean 
      IOP +/- standard deviation (SD) was significantly reduced from 25.7 +/- 6.1 mm Hg at 
      baseline (N = 61) to 15.8 +/- 4.7 mm Hg at year 1 (n = 58) and 16.5 +/- 6.0 mm Hg at 
      year 2 (n = 52) (both p < 0.001). Overall success rates for patients achieving 
      IOP >/=6 mm Hg and <21 mm Hg at year 1 and year 2 were 80.3% and 75.4%, 
      respectively. Mean +/- SD number of glaucoma medications per patient decreased 
      significantly from 2.9 +/- 1.1 at baseline to 0.6 +/- 1.0 at year 1 (n = 58) and 1.0 
      +/- 1.3 at year 2 (n = 52) (both p < 0.001). The most common procedure- and/or 
      device-related AEs were investigator-reported increased IOP and hyphema. Four 
      patients required reoperation. CONCLUSIONS: In this study, sustained reductions 
      in mean IOP and number of glaucoma medications from baseline were observed up to 
      2 years post-surgery. No long-term, sight-threatening AEs were observed.
CI  - (c) 2022 The Author(s). Published by S. Karger AG, Basel.
FAU - Riss, Isabelle
AU  - Riss I
AD  - Pole Ophtalmologique de la Clinique Mutualiste, Pessac, France.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
DEP - 20220922
PL  - Switzerland
TA  - Ophthalmic Res
JT  - Ophthalmic research
JID - 0267442
RN  - 0 (Styrenes)
SB  - IM
MH  - Humans
MH  - *Glaucoma, Open-Angle/drug therapy/surgery
MH  - Prospective Studies
MH  - *Glaucoma/surgery
MH  - Intraocular Pressure
MH  - Trabecular Meshwork/surgery
MH  - Styrenes
MH  - Treatment Outcome
MH  - Retrospective Studies
OTO - NOTNLM
OT  - Ab externo
OT  - Minimally invasive glaucoma surgery
OT  - Mitomycin C
OT  - Primary open-angle glaucoma
OT  - SIBS
EDAT- 2022/09/23 06:00
MHDA- 2023/12/25 06:42
CRDT- 2022/09/22 18:29
PHST- 2021/03/05 00:00 [received]
PHST- 2022/08/14 00:00 [accepted]
PHST- 2023/12/25 06:42 [medline]
PHST- 2022/09/23 06:00 [pubmed]
PHST- 2022/09/22 18:29 [entrez]
AID - 000526960 [pii]
AID - 10.1159/000526960 [doi]
PST - ppublish
SO  - Ophthalmic Res. 2023;66(1):206-217. doi: 10.1159/000526960. Epub 2022 Sep 22.