24-month outcomes of XEN45 gel implant versus trabeculectomy in primary glaucoma.

PURPOSE: To compare the efficacy and safety profiles of XEN implant versus trabeculectomy as a surgical intervention for primary glaucoma.

METHODS

A retrospective cohort study of mild to moderate stage glaucoma patients, who had undergone either XEN implantation or trabeculectomy with adjunctive mitomycin C, was performed in a tertiary eye center.

RESULTS

Fifty-seven eyes for XEN implant and 57 eyes for trabeculectomy with medically uncontrolled glaucoma were included. Preoperative IOP was 16-33 mmHg. Visual field mean deviation was -9.11±6.93 dB in XEN group, and -9.67±5.06 dB in trabeculectomy group (p = 0.195). At the 24-month timepoint, mean IOP was reduced from 21.6±4.0 to 14.6±3.5 mmHg (32.4% reduction) in the XEN group (p<0.001), and from 22.5±5.8 to 12.5±4.1 mmHg (44.4% reduction) in the trabeculectomy group (p<0.001). Final IOP in XEN was significantly higher than trabeculectomy (p = 0.008) with lesser mean IOP percentage reduction at month 24 (p = 0.045). Mean number of medications was reduced from 2.2±1.4 to 0.5±0.7 in XEN group (p<0.001), and from 2.4±0.7 to 0.8±1.3 in trabeculectomy group (p<0.001). Final number of medications was not different between the groups (p = 0.225). Surgical success was comparable between XEN and trabeculectomy group. Overall success was 71.4% vs. 73.3% (p = 0.850), and complete success was 62.9% vs. 62.2% (p = 0.954), respectively. XEN had lower rate of numerical hypotony than trabeculectomy. No serious complication occurred in either procedure group.

CONCLUSION

At 24 months, XEN showed a rate of success comparable to that of trabeculectomy. Although XEN had a higher final IOP than trabeculectomy, XEN achieved 32% IOP reduction, and achieved final IOP in mid-teen level. No serious complication occurred in either group. XEN can be applied for treatment of mild to moderate stages of glaucoma in Southeast Asian patients.