Purpose: To evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation.
Methods: Prospective real-world evidence study included 39 eyes (of 36 patients) with primary open-angle glaucoma without previous glaucoma surgery and with uncontrolled intraocular pressure (IOP), glaucoma progression, or intolerance to IOP-lowering therapy. Patients underwent mitomycin C-augmented XEN implantation either as a stand-alone procedure or combined with cataract extraction. 5-Fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria (analogous to pro re nata regimen in age-related macular degeneration treatment). Primary outcome was unqualified success, defined as postoperative IOP < 18 mmHg and > 20% reduction from medicated baseline without any antiglaucoma medications and no detected glaucoma progression.
Results: At median follow-up of 8 months (range 3-24 months), IOP decreased from a medicated baseline value of 23 mmHg (95% CI 21-24 mmHg) to 13 mmHg (95% CI 12-15 mmHg) and number of medications decreased from 3 (95% CI 2-3) to 0 (p < 0.0001 for both). Median number of 5-fluorouracil injections per eye was 3 (95% CI 2-3), and median time to first injection was 0.5 months (95% CI 0.25-3 months) after surgery. Thirteen eyes (33.3%) underwent ≥ 1 needling, and surgical revision was performed in three cases (7.7%). The primary outcome measure, which allows performing additional procedures, was achieved in 27 eyes (69%).
Conclusions: 5-Fluorouracil subconjunctival injections are safe and effective in postoperative management of bleb failure after XEN implantation and represent a viable alternative to other methods.
Keywords: 5-Fluorouracil; Glaucoma; Minimally invasive glaucoma surgery; Stent; XEN.