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.

No abstract

Précis: XEN gel stent and nonpenetrating deep sclerectomy, both either alone or in combination with cataract surgery, significantly lowered the intraocular pressure (IOP) and reduced the number of antiglaucoma medications in patients with open angle glaucoma, with no significant differences between them. Purpose: To compare the surgical outcomes of XEN45 implant and nonpenetrating deep sclerectomy (NPDS), either alone or in combination with cataract surgery, in patients with ocular hypertension and open angle glaucoma (OAG). A retrospective and single-center cohort study was conducted on consecutive patients who underwent a XEN45 implant or an NPDS, either alone or in combination with phacoemulsification. The primary endpoint was the mean change in IOP from the baseline to the last follow-up visit. One hundred twenty-eight eyes, 65 (50.8%) eyes in the NPDS group and 63 (49.2%) eyes in the XEN group, were included in the study. The mean preoperative IOP was significantly lowered from 17.6±5.3 mm Hg and 17.8±6.2 mm Hg to 12.6±2.6 mm Hg and 13.8±2.8 mm Hg at month 12 in the XEN and NPDS groups, respectively; P<0.0001 each. At month 12, 70 (54.7%) eyes were classified as a success, with no significant differences between XEN (57.1%; 36/63 eyes) and NPDS (52.3%; 34/65 eyes) (mean difference: 4.8%; 95% CI: −30.5% to 20.8%; P=0.7115). The number of ocular hypotensive medications was significantly reduced in the XEN (from 2.1±0.7–0.2±0.5, P<0.0001) and in the NPDS (from 2.0±0.8 to 0.3±0.6, P<0.0001) groups, with no significant differences between them (P=0.2629). The incidence of postoperative adverse events in the overall study population was 12.5%, with no significant differences between groups (P=0.1275). Seven (11.1%) eyes underwent needling (XEN group) and 10 (15.4%) goniopuncture (NPDS group); P=0.4753. Conclusions: XEN45 implant and the NPDS, either alone or in combination with cataract surgery, significantly lowered IOP and reduced the number of ocular hypotensive medications in ocular hypertension and patients with open angle glaucoma.