Impact of Primary Needling on the XEN Implant Clinical Outcomes: A Real-Life Retrospective Study

Abstract

To assess the effectiveness and safety of primary-needling in eyes who underwent a XEN45 implant. Methods: Retrospective and single center study. Consecutive patients with early-to-moderate open-angle glaucoma (OAG) or ocular hypertension, who underwent XEN45 surgery, either alone or combined with phacoemulsification, and had at least a valid 12-month post-operative visit, were included in the study. Primary needling was performed by using a 30-gauge needle without viscoelastic. Subjects were divided in two groups: Eyes who underwent XEN+primary-needling (needling) and those who underwent XEN without primary-needling (no-needling). The primary end-point was the mean change in IOP from baseline to the last follow-up visit. Results: Sixty-three eyes, 19 (30.2%) in the needling group and 44 (69.8%) in the no-needling one, were included in the study. There were not significant differences in mean IOP lowering between needling and no-needling groups at month-12 (mean difference −2.5 ±5.3 mm Hg, p=0.0926). No significant differences in mean reduction of ocular-hypotensive medications were observed between needling and no-needling groups, p=0.8690. At month-12, 50 (80.6%) had blebs considered as functioning, with no difference between groups, p = 0.5631. At month-12, 59 (93.7%) eyes were classified as success, with no significant differences between needling (17/19) and no-needling (42/44) groups, p=0.3754. Secondary needling was performed in 8 (12.7%) eyes, without differences between groups (p=0.6333). Conclusion: Primary needling, at the time of surgery, was a safe procedure in OAG patients who underwent a XEN implant, although it was not associated with a lower postoperative IOP or less ocular hypotensive medications.

XEN Gel Stent Versus Nonpenetrating Deep Sclerectomy in Ocular Hypertension and Open Angle Glaucoma Patients

“…XEN implant was placed, under topical anesthesia, in the superior nasal quadrant using a standard ab interno technique following a previously described technique, 23,24 under topical anesthesia. Intraoperatively, 0.1 mL of mitomycin-C (MMC) 0.01% or 0.02% was subconjunctivally injected under the Tenon capsule, depending on the estimated preoperative risk of fibrosis.…”

“…[14][15][16][17] Different studies have shown the good intraocular pressure (IOP)-lowering effect of the XEN device, either alone or in combination with cataract surgery, in patients with glaucoma. [18][19][20][21][22][23][24] Indeed, the results of a systematic review and meta-analysis published recently have shown a mean (95% CI) IOP lowering from a baseline of -7.8 (-7.4 to -8.2) mm Hg and -8,4 (-6.9 to -9.8) mm Hg in the eyes who underwent XEN-solo and XEN+Phacoemulsification, respectively. 25 Despite the large amount of available evidence that has evaluated the efficacy and safety of the NPDS and XENprocedures, as far we know, only 1 study has compared these 2 surgeries in solo procedure 26 and only 1 retrospective study has compared them in combination with cataract surgery.…”

“…Different studies have shown the good intraocular pressure (IOP)–lowering effect of the XEN device, either alone or in combination with cataract surgery, in patients with glaucoma 18–24. Indeed, the results of a systematic review and meta-analysis published recently have shown a mean (95% CI) IOP lowering from a baseline of -7.8 (-7.4 to -8.2) mm Hg and -8,4 (-6.9 to -9.8) mm Hg in the eyes who underwent XEN-solo and XEN+Phacoemulsification, respectively 25…”

Anterior Segment Optical Coherence Tomography for Cases of High Intraocular Pressure Following XEN Implant for Glaucoma

“…14 Specifically, since the fibrosis can surround a hyporeflective cystic space or fill the SS, the authors defined nonfunctional blebs as encapsulated or flat, respectively. 14 Moreover, the AS-OCT allows a clear visualization of the device, its pathway, and patency at the internal and external ostium. 15 The IOP measurements above the target are not always indicative of an implant failure.…”

“…Nowadays, anterior segment optical coherence tomography (AS-OCT) has improved bleb morphology analysis. Bleb morphology has been correlated with the long-term efficacy of XEN gel stent implantation, 11–13 and a recent study classified XEN blebs according to their functionality 14 . Specifically, since the fibrosis can surround a hyporeflective cystic space or fill the SS, the authors defined nonfunctional blebs as encapsulated or flat, respectively 14 .…”