Abstract
PurposeTo evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation.MethodsProspective 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.ResultsAt 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%).Conclusions5-Fluorouracil subconjunctival injections are safe and effective in postoperative management of bleb failure after XEN implantation and represent a viable alternative to other methods.
Highlights
The introduction of minimally invasive glaucoma surgery (MIGS) devices is a recent innovation that has changed the therapeutic perspective in glaucoma surgery
A total of 39 eyes without previous glaucoma surgery were included in the study; two patients had combined surgery in both eyes; and one patient had a stand-alone phakic procedure in both eyes
The requirement for 5-FU injections was significantly lower in phakic eyes that received the XEN Gel Stent compared with pseudophakic eyes and eyes that had undergone a combined procedure (p \ 0.05)
Summary
The introduction of minimally invasive glaucoma surgery (MIGS) devices is a recent innovation that has changed the therapeutic perspective in glaucoma surgery. One MIGS device is the XEN Gel Stent (Allergan plc, Irvine, CA), a 6-mm-long stent of collagen-derived gelatin cross-linked with glutaraldehyde [1]. The stent allows outflow of aqueous humor from the anterior chamber (AC) into the subconjunctival space. It is placed ab interno with less damage to the ocular surface than with traditional methods, and with an inner lumen diameter of 45 lm, it limits postoperative hypotony. The XEN Gel Stent received approval from the United States Food and Drug Administration in 2016 [4]
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