TY - JOUR
T1 - Comparison of Clinical Outcomes with Open Versus Closed Conjunctiva Implantation of the XEN45 Gel Stent
AU - Do, Anna
AU - McGlumphy, Elyse
AU - Shukla, Aakriti
AU - Dangda, Sonal
AU - Schuman, Joel S.
AU - Boland, Michael V.
AU - Yohannan, Jithin
AU - Panarelli, Joseph F.
AU - Craven, E. Randy
N1 - Funding Information:
J.S.S.: Consultant ? Aerie Pharmaceuticals, Boehringer Ingelheim, Carl Zeiss Meditec, Ocular Therapeutix, Opticient, Perfuse, Regeneron; Equity ? Aerie Pharmaceuticals, Inc, Ocugenix, Ocular Therapeutix, Opticient; Grant Support ? BrightFocus Foundation, National Eye Institute; Intellectual Property ? Massachusetts Eye and Ear Infirmary, Massachusetts Institute of Technology, New York University, Ocugenix, Tufts University, University of Pittsburgh. Royalties: Ocugenix, SLACK.Supported by a grant from Allergan to Johns Hopkins, and an unrestricted grant from Research to Prevent Blindness (New York, NY) to the Department of Ophthalmology, NYU Langone Health, NYU Grossman School of Medicine, New York, NY (Principal Investigator: J.S.S.). Obtained funding: Craven, Panarelli, Schuman; Study was performed as part of regular employment duties at both NYU and JHU.
Publisher Copyright:
© 2020 American Academy of Ophthalmology
PY - 2021/7/1
Y1 - 2021/7/1
N2 - Purpose: To describe the efficacy and safety of open versus closed conjunctival implantation of the XEN45 Gel Stent (Allergan Inc). Design: Retrospective, multicenter study. Participants: A total of 137 patients with glaucoma who underwent XEN45 implantation via open or closed conjunctival methods. The XEN45 was implanted as a stand-alone procedure or at the time of cataract surgery by 5 surgeons. Methods: Patient demographics, diagnoses, preoperative and postoperative clinical data, outcome measures including intraocular pressure (IOP), use of glaucoma medications, visual acuity, and complications were collected. Statistical analyses were performed with P < 0.05 as significant. Main Outcome Measures: Failure was defined as less than 20% reduction of IOP from medicated baseline or IOP >21 mmHg at 2 consecutive visits at postoperative month 1 and beyond, the need for subsequent operative intervention or additional glaucoma surgery, or a catastrophic event such as loss of light perception. Eyes that had not failed by these criteria and were not on glaucoma medications were considered complete successes. Eyes that had not failed but required glaucoma medications were defined as qualified successes. Results: Complete success was achieved in 31% and 56% of the closed and open groups, respectively (P = 0.01). Qualified success was achieved in 53% and 71% of the closed and open groups, respectively (P = 0.06). At postoperative month 12, the open conjunctiva group was using fewer glaucoma medications than the closed group (0.9 vs. 1.8, respectively; P = 0.02). At postoperative month 12, the open group had a significantly greater percentage of IOP reduction compared with the closed group (43.1% vs. 24.8%, respectively; P = 0.02). Postoperative needling rates were higher in the closed group compared with the open group (36.1% vs. 11.8%, P = 0.001). Conclusions: Implantation of the XEN45 with opening of the conjunctiva is a safe and efficacious procedure to lower IOP with comparable success rate and lower needling rate compared with the closed conjunctiva technique. Prospective evaluation of the various methods for XEN45 implantation will allow for further comparison.
AB - Purpose: To describe the efficacy and safety of open versus closed conjunctival implantation of the XEN45 Gel Stent (Allergan Inc). Design: Retrospective, multicenter study. Participants: A total of 137 patients with glaucoma who underwent XEN45 implantation via open or closed conjunctival methods. The XEN45 was implanted as a stand-alone procedure or at the time of cataract surgery by 5 surgeons. Methods: Patient demographics, diagnoses, preoperative and postoperative clinical data, outcome measures including intraocular pressure (IOP), use of glaucoma medications, visual acuity, and complications were collected. Statistical analyses were performed with P < 0.05 as significant. Main Outcome Measures: Failure was defined as less than 20% reduction of IOP from medicated baseline or IOP >21 mmHg at 2 consecutive visits at postoperative month 1 and beyond, the need for subsequent operative intervention or additional glaucoma surgery, or a catastrophic event such as loss of light perception. Eyes that had not failed by these criteria and were not on glaucoma medications were considered complete successes. Eyes that had not failed but required glaucoma medications were defined as qualified successes. Results: Complete success was achieved in 31% and 56% of the closed and open groups, respectively (P = 0.01). Qualified success was achieved in 53% and 71% of the closed and open groups, respectively (P = 0.06). At postoperative month 12, the open conjunctiva group was using fewer glaucoma medications than the closed group (0.9 vs. 1.8, respectively; P = 0.02). At postoperative month 12, the open group had a significantly greater percentage of IOP reduction compared with the closed group (43.1% vs. 24.8%, respectively; P = 0.02). Postoperative needling rates were higher in the closed group compared with the open group (36.1% vs. 11.8%, P = 0.001). Conclusions: Implantation of the XEN45 with opening of the conjunctiva is a safe and efficacious procedure to lower IOP with comparable success rate and lower needling rate compared with the closed conjunctiva technique. Prospective evaluation of the various methods for XEN45 implantation will allow for further comparison.
KW - Gel stent
KW - Glaucoma
KW - MIGS
KW - Minimally invasive glaucoma surgery
KW - XEN
KW - Cataract Extraction
KW - Humans
KW - Glaucoma Drainage Implants
KW - Treatment Outcome
KW - Glaucoma, Open-Angle/surgery
KW - Conjunctiva/surgery
KW - Stents/adverse effects
KW - Retrospective Studies
UR - http://www.scopus.com/inward/record.url?scp=85112484161&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85112484161&partnerID=8YFLogxK
U2 - 10.1016/j.ogla.2020.12.003
DO - 10.1016/j.ogla.2020.12.003
M3 - Article
C2 - 33321200
AN - SCOPUS:85112484161
SN - 2589-4234
VL - 4
SP - 343
EP - 349
JO - Ophthalmology Glaucoma
JF - Ophthalmology Glaucoma
IS - 4
ER -