PMID- 28784554
OWN - NLM
STAT- MEDLINE
DCOM- 20171102
LR  - 20230512
IS  - 1879-1891 (Electronic)
IS  - 0002-9394 (Linking)
VI  - 183
DP  - 2017 Nov
TI  - Performance and Safety of a New Ab Interno Gelatin Stent in Refractory Glaucoma 
      at 12 Months.
PG  - 25-36
LID - S0002-9394(17)30324-0 [pii]
LID - 10.1016/j.ajo.2017.07.023 [doi]
AB  - PURPOSE: To evaluate the intraocular pressure (IOP)-lowering performance and 
      safety of an ab interno gelatin stent (XEN 45 Gel Stent, Allergan plc, Irvine, 
      California, USA), a minimally invasive glaucoma surgery device, in refractory 
      glaucoma. DESIGN: Single-arm, open-label, multicenter clinical study. METHODS: 
      Following mitomycin C pretreatment, the stent was placed ab interno in patients 
      who failed prior filtering/cilioablative procedure or had uncontrolled IOP on 
      maximum-tolerated medical therapy, with medicated IOP >/=20 and </=35 mm Hg and 
      visual field mean deviation </=-3 dB. Primary performance outcomes: patients (%) 
      achieving >/=20% IOP reduction from baseline on the same or fewer medications and 
      mean IOP change from baseline at month 12. Procedure-related complications and 
      ocular adverse events (AEs) were assessed. RESULTS: Sixty-five patients were 
      implanted (intent-to-treat/safety population). At 12 months, 75.4% (46/61; 
      observed data) reported >/=20% IOP lowering from baseline on the same or fewer 
      medications. Mean IOP change from baseline was -9.1 mm Hg (95% confidence 
      interval [CI]: -10.7, -7.5) (n = 52; observed data) at 12 months, excluding 
      patients with missing data (n = 4) and those requiring a glaucoma-related 
      secondary surgical intervention (n = 9). Mean medication count decreased from 3.5 
      (baseline) to 1.7 (12 months). No intraoperative complications or unexpected 
      postoperative AEs were reported. Most AEs were mild/moderate; common AEs included 
      needling (without sight-threatening complications), nonpersistent loss of 
      best-corrected visual acuity, and transient hypotony (requiring no surgical 
      intervention). CONCLUSIONS: The gelatin stent reduced IOP and medication use 
      without raising unexpected safety concerns, offering a minimally invasive 
      surgical option for refractory glaucoma patients.
CI  - Copyright (c) 2017 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Grover, Davinder S
AU  - Grover DS
AD  - Glaucoma Associates of Texas, Dallas, Texas. Electronic address: 
      dgrover@glaucomaassociates.com.
FAU - Flynn, William J
AU  - Flynn WJ
AD  - Rashid, Rice, Flynn & Reilly Eye Associates, San Antonio, Texas.
FAU - Bashford, Kent P
AU  - Bashford KP
AD  - Eye Center of Northern Colorado, Fort Collins, Colorado.
FAU - Lewis, Richard A
AU  - Lewis RA
AD  - Sacramento Eye Consultants, Sacramento, California.
FAU - Duh, Yi-Jing
AU  - Duh YJ
AD  - StatServe Consulting Inc, Chino Hills, California.
FAU - Nangia, Rupali S
AU  - Nangia RS
AD  - Allergan plc, Irvine, California.
FAU - Niksch, Barbara
AU  - Niksch B
AD  - Allergan plc, Irvine, California.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170805
PL  - United States
TA  - Am J Ophthalmol
JT  - American journal of ophthalmology
JID - 0370500
RN  - 9000-70-8 (Gelatin)
SB  - IM
CIN - Am J Ophthalmol. 2018 Apr;188:185-186. PMID: 29452693
CIN - Am J Ophthalmol. 2018 Apr;188:186-187. PMID: 29463383
CIN - Eye (Lond). 2023 Apr;37(6):1047-1060. PMID: 35347294
MH  - Aged
MH  - Female
MH  - Filtering Surgery/*methods
MH  - Follow-Up Studies
MH  - *Gelatin
MH  - *Glaucoma Drainage Implants
MH  - Glaucoma, Open-Angle/diagnosis/physiopathology/*surgery
MH  - Gonioscopy
MH  - Humans
MH  - Intraocular Pressure
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - *Stents
MH  - Time Factors
MH  - Trabecular Meshwork/pathology
MH  - Treatment Outcome
MH  - Visual Fields/*physiology
EDAT- 2017/08/09 06:00
MHDA- 2017/11/03 06:00
CRDT- 2017/08/09 06:00
PHST- 2017/05/02 00:00 [received]
PHST- 2017/07/26 00:00 [revised]
PHST- 2017/07/27 00:00 [accepted]
PHST- 2017/08/09 06:00 [pubmed]
PHST- 2017/11/03 06:00 [medline]
PHST- 2017/08/09 06:00 [entrez]
AID - S0002-9394(17)30324-0 [pii]
AID - 10.1016/j.ajo.2017.07.023 [doi]
PST - ppublish
SO  - Am J Ophthalmol. 2017 Nov;183:25-36. doi: 10.1016/j.ajo.2017.07.023. Epub 2017 
      Aug 5.