XEN implant device versus trabeculectomy, either alone or in combination with phacoemulsification, in open-angle glaucoma patients.

PURPOSE

To compare the efficacy and safety of the XEN45 implant with that of trabeculectomy (TRAB), either alone or in combination with phacoemulsification (PHACO), in patients with open-angle glaucoma (OAG).

METHODS

Retrospective, single-center and comparative study conducted on OAG patients. Patients were divided into four groups: group 1 (XEN alone); group 2 (XEN+PHACO); group 3 (TRAB alone); group 4 (TRAB+PHACO). For statistical purposes, groups 1 and 2 were combined (XEN implant), while groups 3 and 4 were also combined (TRAB surgery). The main outcome measure was intraocular pressure (IOP).

RESULTS

Ninety-one patients (121 eyes; 65 XEN and 56 TRAB) were included. IOP reduction was - 6.7 (- 10.4 to - 3.0) mmHg, p = 0.0013; - 3.5 (- 5.0 to - 2.0) mmHg, p < 0.0001; - 8.1 (- 10.4 to - 5.9) mmHg, p < 0.0001l; and - 7.3 (- 9.3 to - 5.3) mmHg, p < 0.0001 in the XEN alone, XEN+PHACO, TRAB alone, and TRAB+PHACO, respectively. At month 12, an IOP ≥ 6 and ≤ 16 mm without treatment was achieved by 44 (67.7%) and 43 (76.8%), p = 0.2687 in the XEN implant and the TRAB surgery groups, respectively. The mean number of antiglaucoma medications was significantly reduced in all the study groups (p < 0.0001 each). Needling occurred in 20.0% (13/65) of eyes in the XEN implant group, while hyphema occurred in 30.4% (17/56) of eyes in the TRAB group.

CONCLUSIONS

XEN implant, either alone or in combination with phacoemulsification, significantly reduces both IOP and the number of antiglaucoma medications to a similar rate than trabeculectomy, but with a better safety profile.