PMID- 34329772
OWN - NLM
STAT- MEDLINE
DCOM- 20220421
LR  - 20230512
IS  - 2589-4196 (Electronic)
IS  - 2589-4196 (Linking)
VI  - 5
IP  - 2
DP  - 2022 Mar-Apr
TI  - Safety and Effectiveness of the PRESERFLO(R) MicroShunt in Primary Open-Angle 
      Glaucoma: Results from a 2-Year Multicenter Study.
PG  - 195-209
LID - S2589-4196(21)00179-4 [pii]
LID - 10.1016/j.ogla.2021.07.008 [doi]
AB  - PURPOSE: To assess the safety and effectiveness of the PRESERFLO(R) MicroShunt 
      (formerly InnFocus MicroShunt) in patients with primary open-angle glaucoma 
      (POAG). DESIGN: The MicroShunt, a controlled ab externo glaucoma filtration 
      surgery device, was investigated in a 2-year, multicenter, single-arm study. 
      PARTICIPANTS: Eligible patients were aged 18-85 years with POAG inadequately 
      controlled on maximal tolerated medical therapy with intraocular pressure (IOP) 
      >/=18 and </=35 mmHg or when glaucoma progression warranted surgery. METHODS: The 
      MicroShunt was implanted as a stand-alone procedure with adjunctive use of 
      topical mitomycin C (MMC; 0.2-0.4 mg/ml) for 2-3 minutes. MAIN OUTCOME MEASURES: 
      The primary effectiveness outcome was IOP reduction and success (not requiring 
      reoperation or pressure failures [IOP > 21 mmHg and < 20% reduction in IOP]) at 
      year 1. Additional end points at year 2 included IOP reduction, success, glaucoma 
      medications, adverse events (AEs), and reoperations. Results are reported in the 
      overall population and subgroups of patients receiving 0.2 or 0.4 mg/ml MMC. 
      RESULTS: In 81 patients, mean (+/- standard deviation [SD]) IOP decreased from 21.7 
      +/- 3.4 mmHg at baseline to 14.5 +/- 4.6 mmHg at year 1 and 14.1 +/- 3.2 mmHg at year 2 
      (P < 0.0001). Overall success (with and without supplemental glaucoma medication 
      use) at year 1 was 74.1%. Mean (+/- SD) number of medications decreased from 2.1 +/- 
      1.3 at baseline to 0.5 +/- 0.9 at year 2 (P < 0.0001), and 73.8% of patients were 
      medication free. Most common nonserious AEs were increased IOP requiring 
      medication or selective laser trabeculoplasty (25.9%) and mild-to-moderate 
      keratitis (11.1%). There were 6 (7.4%) reoperations and 5 (6.2%) needlings by 
      year 2. In an analysis (post hoc) according to MMC concentration, overall success 
      was 78.1% (0.2 mg/ml) and 74.4% (0.4 mg/ml; P = 0.710). In the 0.2 and 0.4 mg/ml 
      MMC groups, 51.9% and 90.3% of patients were medication free, respectively (P = 
      0.001). There was a trend toward lower IOP and higher medication reduction in the 
      0.4 mg/ml MMC subgroup. CONCLUSIONS: In this study, mean IOP and glaucoma 
      medication reductions were significant and sustained over 2 years postsurgery. No 
      long-term, sight-threatening AEs were reported. Further studies may confirm 
      potential risk/benefits of higher MMC concentration.
CI  - Copyright (c) 2021 American Academy of Ophthalmology. Published by Elsevier Inc. 
      All rights reserved.
FAU - Beckers, Henny J M
AU  - Beckers HJM
AD  - University Eye Clinic, Maastricht University Medical Center, Maastricht, the 
      Netherlands. Electronic address: henny.beckers@mumc.nl.
FAU - Aptel, Florent
AU  - Aptel F
AD  - CHU de Grenoble-Alpes, Grenoble, France.
FAU - Webers, Carroll A B
AU  - Webers CAB
AD  - University Eye Clinic, Maastricht University Medical Center, Maastricht, the 
      Netherlands.
FAU - Bluwol, Elisa
AU  - Bluwol E
AD  - Hopital Paris Saint Joseph, Paris, France.
FAU - Martinez-de-la-Casa, Jose M
AU  - Martinez-de-la-Casa JM
AD  - Departamento de Oftalmologia Universidad Complutense, Hospital Clinico San 
      Carlos, OFTARED, Madrid, Spain.
FAU - Garcia-Feijoo, Julian
AU  - Garcia-Feijoo J
AD  - Departamento de Oftalmologia Universidad Complutense, Hospital Clinico San 
      Carlos, OFTARED, Madrid, Spain.
FAU - Lachkar, Yves
AU  - Lachkar Y
AD  - Hopital Paris Saint Joseph, Paris, France.
FAU - Mendez-Hernandez, Carmen D
AU  - Mendez-Hernandez CD
AD  - Departamento de Oftalmologia Universidad Complutense, Hospital Clinico San 
      Carlos, OFTARED, Madrid, Spain.
FAU - Riss, Isabelle
AU  - Riss I
AD  - Pole Ophtalmologique de la Clinique Mutualiste, Bordeaux, France.
FAU - Shao, Hui
AU  - Shao H
AD  - Santen Inc., Emeryville, California.
FAU - Pinchuk, Leonard
AU  - Pinchuk L
AD  - InnFocus Inc., a Santen Company, Miami, Florida.
FAU - Angeles, Raymund
AU  - Angeles R
AD  - Santen Inc., Emeryville, California.
FAU - Sadruddin, Omar
AU  - Sadruddin O
AD  - Santen Inc., Emeryville, California.
FAU - Shaarawy, Tarek M
AU  - Shaarawy TM
AD  - Hopitaux Universitaires de Geneve, Geneva, Switzerland.
LA  - eng
SI  - ClinicalTrials.gov/NCT02177123
PT  - Journal Article
PT  - Multicenter Study
DEP - 20210728
PL  - United States
TA  - Ophthalmol Glaucoma
JT  - Ophthalmology. Glaucoma
JID - 101730510
RN  - 50SG953SK6 (Mitomycin)
SB  - IM
CIN - Ophthalmol Glaucoma. 2022 Jan-Feb;5(1):e1-e2. PMID: 34801438
CIN - Ophthalmol Glaucoma. 2022 Jan-Feb;5(1):e1. PMID: 34801439
CIN - Eye (Lond). 2023 Mar;37(4):644-649. PMID: 35277663
MH  - *Glaucoma/surgery
MH  - *Glaucoma, Open-Angle/drug therapy/surgery
MH  - Humans
MH  - Intraocular Pressure
MH  - Mitomycin
MH  - *Ocular Hypotension/surgery
MH  - Tonometry, Ocular
MH  - *Trabeculectomy
OTO - NOTNLM
OT  - Clinical trial
OT  - Glaucoma filtration surgery
OT  - MIGS
OT  - Primary open-angle glaucoma
EDAT- 2021/07/31 06:00
MHDA- 2022/04/22 06:00
CRDT- 2021/07/30 20:13
PHST- 2021/04/01 00:00 [received]
PHST- 2021/07/16 00:00 [revised]
PHST- 2021/07/21 00:00 [accepted]
PHST- 2021/07/31 06:00 [pubmed]
PHST- 2022/04/22 06:00 [medline]
PHST- 2021/07/30 20:13 [entrez]
AID - S2589-4196(21)00179-4 [pii]
AID - 10.1016/j.ogla.2021.07.008 [doi]
PST - ppublish
SO  - Ophthalmol Glaucoma. 2022 Mar-Apr;5(2):195-209. doi: 10.1016/j.ogla.2021.07.008. 
      Epub 2021 Jul 28.