Ewa Wałek1, Joanna Przeździecka-Dołyk2,3, Iwona Helemejko2, Marta Misiuk-Hojło2. 1. Department of Ophthalmology, Wroclaw Medical University, Borowska 213, Wrocław, Poland. ewka.walek@gmail.com. 2. Department of Ophthalmology, Wroclaw Medical University, Borowska 213, Wrocław, Poland. 3. Department of Optics and Photonics, Faculty of Fundamental Problems of Technology, Wroclaw University of Science and Technology, Wrocław, Poland.
Abstract
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.
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.
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