XEN-45 collagen implant for the treatment of uveitic glaucoma.

IMPORTANCE

The XEN-45 implant, a hydrophilic collagen implant which drains aqueous to the subconjunctival space, has not been investigated in the context of uveitic glaucoma.

BACKGROUND

To determine the safety and efficacy of the XEN-45 collagen implant in eyes with uveitic glaucoma.

DESIGN

Exploratory prospective case series.

PARTICIPANTS

patients with medically uncontrolled uveitic glaucoma.

METHODS

Twenty-four consecutive patients (mean age ± standard deviation [SD] = 45.3 ± 18.1 years) were implanted with the XEN-45 implant.

MAIN OUTCOME MEASURES

The primary outcome measure was intraocular pressure (IOP) reduction at 12 months as compared to baseline. Secondary outcome measures included ocular hypotensive medication use at 12 months, the requirement for further glaucoma surgery and failure. Intraoperative and postoperative complications were documented.

RESULTS

The baseline mean ± SD IOP was 30.5 ± 9.8 mmHg and the mean ± SD number of glaucoma medications required was 3.3 ± 0.8. In 20 eyes (83.3%) in whom conventional glaucoma surgery was originally perceived to be inevitable, further surgery was not required after XEN-45 implantation. The mean IOP was reduced by 60.2% from baseline to 12.2 ± 3.1 mmHg and mean medication usage was reduced to 0.4 ± 0.9 at 12 months (both P < 0.001). One patient had hypotony persisting beyond 2 months that required surgical revision and one patient developed blebitis. The 12-month cumulative Kaplan-Meier survival probability was 79.2%.

CONCLUSIONS AND RELEVANCE

The XEN-45 implant is effective for the treatment of patients with medically uncontrolled uveitic glaucoma. Potentially sight-threatening complications, including bleb-related ocular infection and persistent hypotony, may occur.