PMID- 35277663
OWN - NLM
STAT- MEDLINE
DCOM- 20230313
LR  - 20230512
IS  - 1476-5454 (Electronic)
IS  - 0950-222X (Print)
IS  - 0950-222X (Linking)
VI  - 37
IP  - 4
DP  - 2023 Mar
TI  - Short-term safety and efficacy of Preserflo Microshunt in glaucoma patients: a 
      multicentre retrospective cohort study.
PG  - 644-649
LID - 10.1038/s41433-022-01995-7 [doi]
AB  - BACKGROUND/AIMS: To evaluate 1-year success rates and safety profile of 
      Preserflo Microshunt in glaucoma patients. METHODS: Retrospective multicentre 
      cohort study of 100 consecutive eyes (91 patients) from four tertiary-referral 
      glaucoma centres. Four intraocular pressure (IOP) criteria were defined: A: 
      IOP </= 21 mmHg+IOP reduction >/=20% from baseline; B: IOP </= 18 mmHg+IOP reduction 
      >/=20%; C: IOP </= 15 mmHg+IOP reduction >/=25%; D: IOP</=12 mmHg+IOP reduction >/=30%. 
      Success was defined as qualified or complete based on whether reached with or 
      without medication. Primary outcome was success according to the above criteria. 
      Secondary outcomes included: IOP, best-corrected visual acuity (BCVA), medication 
      use, complications, postoperative interventions, and failure-associated factors. 
      RESULTS: Qualified and complete success rates (95% CI) at 12 months were 
      74%(66-83%) and 58%(49-69%) for criterion A, 72%(63-82%) and 57%(48-68%) for B, 
      52%(43-63%) and 47%(38-58%) for C, 29%(21-40%) and 26%(19-36%) for D. Overall 
      median (interquartile range (IQR)) preoperative IOP decreased from 
      21.5(19-28) mmHg to 13(11-16) mmHg at 12 months. BCVA was not significantly 
      different up to 12 months (p = 0.79). Preoperative median (IQR) number of 
      medications decreased from 3 (2-3) to 0 (0-1) at 12 months. Twelve eyes underwent 
      needling, five surgical revision and one device removal due to corneal oedema. 
      There were no hypotony-related complications. Non-Caucasian ethnicity was the 
      only risk factor consistently associated with increased failure. CONCLUSIONS: 
      Preserflo Microshunt is a viable surgical option in glaucoma patients, with 
      reasonable short-term success rates, decreased medications use, excellent safety 
      profile, smooth postoperative care, and rapid learning curve. Success rates for 
      the most stringent IOP cutoffs were modest, indicating that it may not be the 
      optimal surgery when very low target IOP is required.
CI  - (c) 2022. The Author(s).
FAU - Bhayani, Raj
AU  - Bhayani R
AUID- ORCID: 0000-0003-2003-5895
AD  - Manchester Royal Eye Hospital, Manchester University NHS Foundation Trust, 
      Manchester, UK.
FAU - Martinez de la Casa, Jose Maria
AU  - Martinez de la Casa JM
AD  - Ophthalmology Unit, Department of Ophthalmology and ORL, Faculty of Medicine, 
      Hospital Clinico San-Carlos, Universidad Complutense de Madrid, Instituto de 
      Investigacion Sanitaria del Hospital Clinico San-Carlos (IdISSC), Madrid, Spain.
FAU - Figus, Michele
AU  - Figus M
AD  - Department of Surgical, Medical and Molecular Pathology and Critical Care 
      Medicine, University of Pisa, Pisa, Italy.
FAU - Klabe, Karsten
AU  - Klabe K
AD  - Breyer-Kaymak-Klabe Augenchirurgie, Duesseldorf, Germany.
FAU - Rabiolo, Alessandro
AU  - Rabiolo A
AD  - Department of Ophthalmology, Gloucestershire Hospitals NHS Foundation Trust, 
      Cheltenham, UK.
FAU - Mercieca, Karl
AU  - Mercieca K
AD  - University Hospitals Eye Clinic, Ernst-Abbe Strasse 2, Bonn, Germany. 
      karl.mercieca@ukbonn.de.
AD  - University of Manchester, Manchester, UK. karl.mercieca@ukbonn.de.
LA  - eng
PT  - Comment
PT  - Journal Article
PT  - Multicenter Study
DEP - 20220312
PL  - England
TA  - Eye (Lond)
JT  - Eye (London, England)
JID - 8703986
SB  - IM
CON - Ophthalmol Glaucoma. 2022 Mar-Apr;5(2):195-209. PMID: 34329772
MH  - Humans
MH  - Cohort Studies
MH  - Retrospective Studies
MH  - Treatment Outcome
MH  - *Glaucoma/surgery
MH  - Intraocular Pressure
MH  - *Ocular Hypotension
MH  - *Trabeculectomy
MH  - Follow-Up Studies
PMC - PMC8916945
COIS- Karl Mercieca has the following financial disclosures: Alcon: honorarium; 
      Allergan/Abbvie: consultancy, honorarium and research grants; Bausch & Lomb: 
      honorarium; IOPtima: consultancy; Ivantis: research grants; Santen: consultancy 
      and honorarium; Thea: honorarium; Topcon: honorarium. The other authors have no 
      conflicts of interest.
EDAT- 2022/03/13 06:00
MHDA- 2023/03/14 06:00
PMCR- 2022/03/12
CRDT- 2022/03/12 05:25
PHST- 2021/08/09 00:00 [received]
PHST- 2022/02/16 00:00 [accepted]
PHST- 2022/02/03 00:00 [revised]
PHST- 2022/03/13 06:00 [pubmed]
PHST- 2023/03/14 06:00 [medline]
PHST- 2022/03/12 05:25 [entrez]
PHST- 2022/03/12 00:00 [pmc-release]
AID - 10.1038/s41433-022-01995-7 [pii]
AID - 1995 [pii]
AID - 10.1038/s41433-022-01995-7 [doi]
PST - ppublish
SO  - Eye (Lond). 2023 Mar;37(4):644-649. doi: 10.1038/s41433-022-01995-7. Epub 2022 
      Mar 12.