Comparison of Efficacy and Safety of XEN45 Implant Versus Trabeculectomy in Asian Eyes

Abstract

Combined phacoemulsification and trabeculectomy is able to achieve greater reduction in intraocular pressure (IOP), higher rates of complete surgical success and fewer postoperative manipulations and visits compared with combined phacoemulsification and Xen implantation in glaucomatous eyes.Purpose: Our study aims to compare and understand the differences between the efficacy and safety of XEN45 implantation and trabeculectomy in Asian eyes with glaucoma. Materials and Methods: This was a retrospective, single-center, comparative study of consecutive patients who underwent combined phacoemulsification and trabeculectomy (Phaco-Trab) from January 2013 to June 2014 and combined phacoemulsification and XEN45 implantation (Phaco-Xen) from May 2017 to September 2018 in a tertiary Ophthalmology center in Singapore. Outcome measures included IOP, number of anti-glaucoma eyedrops, success rate, factors leading to success/failure, number of postoperative interventions and visits required, and surgical complications.Results: A total of 137 eyes (91 Phaco-Trab, 46 Phaco-Xen) were included. Phaco-Trab group had greater mean IOP reduction at all time points beyond postoperative month (POM) 1 (mean difference 2.9 to 3.8 mm Hg; P < 0.05), and greater reduction in mean number of antiglaucoma eyedrops beyond POM3, thought this was not statistically significant. At POM12, complete success was achieved in 83.5% in Phaco-Trab and 52.2% of Phaco-Xen group, respectively (P < 0.001). There was no significant factor associated with surgical failure, other than the difference in surgical procedure. Phaco-Trab group required fewer number of postoperative interventions (P = 0.009), with only a mean of 0.1 bleb interventions required per patient, versus 1.5 in Phaco-Xen group (P < 0.001). Safety profiles in both groups were comparable, with no statistically significant difference in intraoperative/postoperative complications. Conclusion:Phaco-Trab has significantly higher reduction in both IOP and number of antiglaucoma medications compared with Phaco-Xen group, with greater surgical success and fewer postoperative manipulations and visits. Safety profiles were comparable.

3-Year Outcomes of XEN Implant Compared With Trabeculectomy, With or Without Phacoemulsification for Open Angle Glaucoma

“…Theilig21 reported a similar incidence of hyphema between the both groups (7% in XEN and 8% in TRAB). Hyphema and hypotonia rates in the TRAB surgery group were higher in our study related to that of Kee et al20 and Nuzzi et al23,30 The high rate of hyphema in our TRAB group study might be related to the characteristics of the study population, like the use of anticoagulants. Unfortunately, we did not document it in the variables of our study.…”

“…This study confirms these results. Furthermore, this IOP reduction showed a tendency to decrease over time in all groups 18,20,21,23. Interestingly, the IOP difference between the XEN alone and TRAB alone group in our study continued to be not statistically significant at any time point 18.…”

“…Furthermore, this IOP reduction showed a tendency to decrease over time in all groups. 18,20,21,23 Interestingly, the IOP difference between the XEN alone and TRAB alone group in our study continued to be not statistically significant at any time point. 18 The small number of eyes in the XEN45 alone group might be a probable reason for this finding; therefore, the study was underpowered to detect differences between these groups.…”

“…XEN45 implant eyes undergo needling more than TRAB surgery patients. [18][19][20][21][22][23][24][25][26] We performed needling for more patients in the XEN45 group (19%) compared with Kee et al 20 (1.5%) and Wagner et al 22 (16%); however, the incidence was less than that observed in other studies. 19,21,23,25,26 The needling rate published by studies with 36-month followup is 36.6%-55.4%.…”

“…29 The result agrees with that found in other studies about no difference in the postoperative NOAM between the XEN45 implant and TRAB surgery. [18][19][20][21][22][23][24] There are more limitations to this study. The retrospective design carries a risk of selection bias, the variability of treatment, IOP measurement, and loss of follow-up.…”