PMID- 36972738
OWN - NLM
STAT- MEDLINE
DCOM- 20230717
LR  - 20231118
IS  - 1879-1891 (Electronic)
IS  - 0002-9394 (Linking)
VI  - 252
DP  - 2023 Aug
TI  - Gel Stent Versus Trabeculectomy: The Randomized, Multicenter, Gold-Standard 
      Pathway Study (GPS) of Effectiveness and Safety at 12 Months.
PG  - 306-325
LID - S0002-9394(23)00134-4 [pii]
LID - 10.1016/j.ajo.2023.03.026 [doi]
AB  - PURPOSE: To compare effectiveness and safety of the gel stent to trabeculectomy 
      in open-angle glaucoma (OAG). DESIGN: Prospective, randomized, multicenter, 
      noninferiority study. METHODS: Patients with OAG and intraocular pressure (IOP) 
      15 to 44 mm Hg on topical IOP-lowering medication were randomized 2:1 to gel 
      stent implantation or trabeculectomy. Primary end point (surgical success): 
      percentage of patients at month 12 achieving >/=20% IOP reduction from baseline 
      without medication increase, clinical hypotony, vision loss to counting fingers, 
      or secondary surgical intervention (SSI) in a noninferiority test with 24% 
      margins. Secondary end points (month 12) included mean IOP and medication count, 
      postoperative intervention rate, visual recovery, and patient-reported outcomes 
      (PROs). Safety end points included adverse events (AEs). RESULTS: At month 12, 
      the gel stent was statistically noninferior to trabeculectomy (between-treatment 
      difference [Delta], -6.1%; 95% CI, -22.9%, 10.8%); 62.1% and 68.2% achieved the 
      primary end point, respectively (P=.487); mean IOP and medication count 
      reductions from baseline were significant (P<.001); and the IOP change-related Delta 
      (2.8 mm Hg) favored trabeculectomy (P=.024). The gel stent resulted in fewer eyes 
      requiring in-office postoperative interventions (P=.024 after excluding laser 
      suture lysis), faster visual recovery (P</=.048), and greater 6-month improvements 
      in visual function problems (ie, PROs; P</=.022). The most common AEs were reduced 
      visual acuity at any time (gel stent, 38.9%; trabeculectomy, 54.5%) and hypotony 
      (IOP <6 mm Hg at any time) (gel stent, 23.2%; trabeculectomy, 50.0%). 
      CONCLUSIONS: At month 12, the gel stent was statistically noninferior to 
      trabeculectomy, per the percentage of patients achieving >/=20% IOP reduction from 
      baseline without medication increase, clinical hypotony, vision loss to counting 
      fingers, or SSI. Trabeculectomy achieved a statistically lower mean IOP, 
      numerically lower failure rate, and numerically lower need for supplemental 
      medications. The gel stent resulted in fewer postoperative interventions, better 
      visual recovery, and fewer AEs.
CI  - Copyright (c) 2023 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Sheybani, Arsham
AU  - Sheybani A
AD  - Washington University School of Medicine (A.S.), St Louis, Missouri, USA. 
      Electronic address: sheybaniar@wustl.edu.
FAU - Vera, Vanessa
AU  - Vera V
AD  - Allergan, an AbbVie company (V.V.), Irvine, California, USA.
FAU - Grover, Davinder S
AU  - Grover DS
AD  - Glaucoma Associates of Texas (D.S.G.), Dallas, Texas, USA.
FAU - Vold, Steven D
AU  - Vold SD
AD  - Vold Vision (S.D.V.), Fayetteville, Arkansas, USA.
FAU - Cotter, Frank
AU  - Cotter F
AD  - Vistar Eye Center (F.C.), Roanoke, Virginia, USA.
FAU - Bedrood, Sahar
AU  - Bedrood S
AD  - Acuity Eye Group (S.B.), Arcadia, California, USA; Advanced Vision Care (S.B.), 
      Los Angeles, California, USA.
FAU - Sawhney, Gagan
AU  - Sawhney G
AD  - Georgia Eye Partners (G.S.), Atlanta, Georgia, USA.
FAU - Piette, Scott D
AU  - Piette SD
AD  - Mid Florida Eye Center (S.D.P.), Leesburg, Florida, USA.
FAU - Simonyi, Susan
AU  - Simonyi S
AD  - Allergan, an AbbVie company (S.S.), Singapore.
FAU - Gu, Xuemin
AU  - Gu X
AD  - AbbVie (X.G.), Madison, New Jersey, USA.
FAU - Balaram, Mini
AU  - Balaram M
AD  - Nethra Consulting LLC (M.B.), Princeton, New Jersey, USA.
FAU - Gallardo, Mark J
AU  - Gallardo MJ
AD  - El Paso Eye Surgeons P.A. (M.J.G.), El Paso, Texas, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03654885
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20230325
PL  - United States
TA  - Am J Ophthalmol
JT  - American journal of ophthalmology
JID - 0370500
SB  - IM
MH  - Humans
MH  - *Trabeculectomy/methods
MH  - *Glaucoma, Open-Angle/surgery
MH  - Prospective Studies
MH  - Intraocular Pressure
MH  - Trabecular Meshwork/surgery
MH  - Vision Disorders/surgery
MH  - Stents
MH  - Treatment Outcome
EDAT- 2023/03/28 06:00
MHDA- 2023/07/17 06:42
CRDT- 2023/03/27 20:22
PHST- 2022/10/03 00:00 [received]
PHST- 2023/03/16 00:00 [revised]
PHST- 2023/03/18 00:00 [accepted]
PHST- 2023/07/17 06:42 [medline]
PHST- 2023/03/28 06:00 [pubmed]
PHST- 2023/03/27 20:22 [entrez]
AID - S0002-9394(23)00134-4 [pii]
AID - 10.1016/j.ajo.2023.03.026 [doi]
PST - ppublish
SO  - Am J Ophthalmol. 2023 Aug;252:306-325. doi: 10.1016/j.ajo.2023.03.026. Epub 2023 
      Mar 25.