PMID- 33137019
OWN - NLM
STAT- MEDLINE
DCOM- 20210909
LR  - 20230912
IS  - 1536-481X (Electronic)
IS  - 1057-0829 (Print)
IS  - 1057-0829 (Linking)
VI  - 30
IP  - 3
DP  - 2021 Mar 1
TI  - Long-term Results of the PRESERFLO MicroShunt in Patients With Primary Open-angle 
      Glaucoma From a Single-center Nonrandomized Study.
PG  - 281-286
LID - 10.1097/IJG.0000000000001734 [doi]
AB  - PRECIS: The MicroShunt was implanted in 23 patients with primary open-angle 
      glaucoma (POAG) in a feasibility study. Reductions in intraocular pressure (IOP) 
      and medications were sustained for up to 5 years with no long-term 
      sight-threatening adverse events (AEs). PURPOSE: The purpose of this study was to 
      assess the long-term effectiveness and safety of the PRESERFLO MicroShunt (8.5 mm 
      long, 70 microm lumen surgical device, formerly known as the InnFocus MicroShunt) in 
      POAG. PATIENTS AND METHODS: In a feasibility study (NCT00772330), patients with 
      POAG inadequately controlled on maximum tolerated therapy with IOP >/=18 to 
      </=40 mm Hg underwent MicroShunt implantation with adjunctive mitomycin C 
      (0.4 mg/mL), alone or in combination with cataract surgery. Years 1 to 3 findings 
      have previously been reported. Endpoints of this extension study included IOP 
      reduction and success at years 4 and 5 (primary), incidence of AEs, medication 
      use, and reoperations. RESULTS: Mean IOP was reduced from 23.8+/-5.3 mm Hg at 
      baseline to 12.8+/-5.6 mm Hg (year 4; n=21) and 12.4+/-6.5 mm Hg (year 5; n=21). 
      Overall success (with/without medication use) was 87.0% (year 4) and 82.6% (year 
      5). The mean number of medications reduced from 2.4+/-1.0 at baseline to 0.8+/-1.3 
      (year 5). Common (>/=5% of patients) AEs included corneal edema (n=4), transient 
      hypotony (n=4), bleb-related complications (n=3), and device touching the iris 
      (n=3). There were 4 reports of serious AEs and 2 reoperations. CONCLUSIONS: In 
      this extension study, sustained reductions in mean IOP and medications were 
      observed up to 5 years post-MicroShunt implantation. There were no reports of 
      long-term sight-threatening AEs and a low rate of postoperative interventions.
CI  - Copyright (c) 2021 The Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Batlle, Juan F
AU  - Batlle JF
AD  - Laser Center, Santo Domingo, Dominican Republic.
FAU - Corona, Adalgisa
AU  - Corona A
FAU - Albuquerque, Rachel
AU  - Albuquerque R
LA  - eng
SI  - ClinicalTrials.gov/NCT00772330
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Glaucoma
JT  - Journal of glaucoma
JID - 9300903
RN  - 50SG953SK6 (Mitomycin)
SB  - IM
MH  - *Glaucoma Drainage Implants
MH  - *Glaucoma, Open-Angle/drug therapy/surgery
MH  - Humans
MH  - Intraocular Pressure
MH  - Mitomycin
MH  - Tonometry, Ocular
MH  - Treatment Outcome
PMC - PMC8041565
COIS- Disclosure: J.F.B. is a consultant for InnFocus Inc. (a Santen Pharmaceutical Co. 
      Ltd company) and received travel grants from Santen. The remaining authors 
      declare no conflict of interest.
EDAT- 2020/11/03 06:00
MHDA- 2021/09/10 06:00
PMCR- 2021/04/12
CRDT- 2020/11/02 17:13
PHST- 2020/06/25 00:00 [received]
PHST- 2020/10/11 00:00 [accepted]
PHST- 2020/11/03 06:00 [pubmed]
PHST- 2021/09/10 06:00 [medline]
PHST- 2020/11/02 17:13 [entrez]
PHST- 2021/04/12 00:00 [pmc-release]
AID - 00061198-202103000-00028 [pii]
AID - 10.1097/IJG.0000000000001734 [doi]
PST - ppublish
SO  - J Glaucoma. 2021 Mar 1;30(3):281-286. doi: 10.1097/IJG.0000000000001734.