To describe the efficacy and safety of open versus closed conjunctival implantation of the XEN45 Gel Stent.
Retrospective multicenter study.
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 five surgeons.
Patient demographics, diagnoses, preoperative and postoperative clinical data, outcome measures including intraocular pressure (IOP), use of glaucoma medications, visual acuity, complications were collected. Statistical analyses were performed with P<0.05 as significant.
Failure was defined as less than 20% reduction of IOP from medicated baseline or IOP >21 mm Hg at two consecutive visits at postoperative month 1 and beyond, the need for subsequent operative intervention or additional glaucoma surgery, or catastrophic event such as loss of light perception. Eyes that had not failed by the above 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.
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 less glaucoma medications than the closed group (0.9 vs 1.8, respectively p=0.02). Furthermore, at postoperative month 12, the open group had a significantly greater percentage of IOP reduction compared to the closed group (43.1% vs 24.8%, respectively p=0.02). Postoperative needling rates were higher in the closed group compared to the open group (36.1% vs 11.8%, p=0.001).
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 to the closed conjunctiva technique. Prospective evaluation of the various methods for XEN45 implantation will allow for further comparison.

Copyright © 2020. Published by Elsevier Inc.