Real-world comparison of efficacy and safety of XEN45 implant with phacoemulsification versus iStent inject® W with phacoemulsification.
Objective: To compare iStent inject® W+phacoemulsification with XEN45 implant+phacoemulsification over 12 months in mild to moderate glaucoma patients needing cataract surgery at the Hospital General Universitario Dr. Balmis, Alicante, Spain.
Methods: Retrospective clinical cohort study. Consecutive patients who underwent phacoemulsification either combined with XEN45 implantation or iStent inject® W from 2020 to 2022 were included. The main outcome measure was surgical success at 12 months postoperatively. Intraocular pressure (IOP), number of antiglaucoma medications, intraoperative and postoperative complications, number of revision surgeries, use of the operating room and required visits were also evaluated.
Results: A total of 167 eyes were included in the study, with 101 eyes of 61 patients undergoing iStent+PHACO and 66 eyes of 46 patients undergoing XEN45+PHACO. The proportion of patients achieving a complete success (IOP≥5 and ≤ 18mmHg without medication) at the conclusion of the 12-month follow-up was 47.9% (35/73) in the iStent+PHACO and 48.2% (27/56) in the XEN45+PHACO surgery group, P=1.000. The mean (95% CI) IOP reduction at the conclusion of the study follow-up was -2.4 (-3.5 to -1.3mmHg, P<0.001, iStent+PHACO) and -3.10 (-4.8 to -1.4mmHg, P<0.001, XEN45+PHACO). The mean number of antiglaucoma medications was significantly reduced in both study groups. Rates of intraoperative complications (5 vs. 15.2%), postoperative complications (1 vs. 46.2%), reoperations (0 vs. 24.6%), mean number of operating room visits (1 vs. 1.41), and mean number of required postoperative visits (4.50 vs. 11.13) were all statistically significantly higher in the XEN45+PHACO group (< 0.001).
Conclusions: Both procedures achieved similar surgical success rates, with comparable reductions in IOP and the number of antiglaucoma medications. After one year, a modest IOP reduction of 10.83% was observed in the iStent group and 13.65% in the Xen group. However, the iStent inject® W demonstrated a better intraoperative and postoperative safety profile.