XEN 45 Gel Stent Implantation in Open Angle Glaucoma: 5-Year Results of a Prospective Study

Abstract

Precis: XEN 45 Gel Stent is safe and effective for 3 years. The study results provide useful insight into the outcome of XEN 45 Gel Stent surgery over 5 years in daily clinical practice. Purpose: To evaluate 5-year outcomes of XEN 45 gel stent implantation (XEN) in patients with open-angle glaucoma. Patients and Methods: This is a prospective, single-center, interventional study. XEN implantation either alone (XEN) or combined with phacoemulsification (Phaco + XEN) was performed on 170 consecutive eyes (126 patients) with uncontrolled intraocular pressure (IOP) or disease progression despite medical treatment. ‘Complete’ surgical success at 60 months was defined as unmedicated IOP ≤15 mmHg and a relative IOP reduction ≥ 20% from medicated baseline, while ‘qualified’ success allowed fewer ocular hypotensive medications (OHM) than at baseline. Other definitions of success with various IOP targets were also analyzed. Secondary outcomes included mean IOP and IOP lowering medication changes, and rates of re-operations. Results: Mean age was 78.1±9.2 years and 70.3% were female. Mean medicated IOP decreased from 19.8±7.7 mmHg (19.6±7.1 [XEN] vs. 19.8±7.0 mmHg [Phaco+XEN]) at baseline to 12.6±3.1 mmHg (12.5± 3.1 [XEN] vs. 12.6±3.1 [Phaco+XEN]) at 5 years (−37.0%; P < 0.001). Medications decreased from 2.0±1.3 (2.0±1.3 [XEN] vs. 2.0±1.3 [Phaco+XEN]) to 0.8±1.1 (0.8±1.1 [XEN] vs. 0.8±1.1 [Phaco + XEN]) (−60%; P<0.001). Needling was performed in 84 eyes (49%), and 19.4% underwent a secondary surgical intervention. Complete success at 3 years was a strong predictor of success at 5 years (OR:3.06, P<0.01), while needling was associated with higher rates of failure (OR:3.6, P<0.01). Conclusion: At 5 years, XEN gel stent implantation was a safe procedure and achieved clinically meaningful IOP and medication reduction. Success at 3 years is a predictor of success at 5 years. Needling correlates with higher failure rates.

Two-year outcomes of Xen 45 gel stent implantation in patients with open-angle glaucoma: real-world data from the Fight Glaucoma Blindness registry

“…Torbey et al presented 5-year outcomes of Xen gel stent in 80 eyes. 22 CS was achieved (IOP threshold of ≤15 mm Hg) in 33.5% and QS (IOP threshold of ≤15 mm H) in 44.7%.…”

“…Other studies have shown no significant difference in outcomes between these two groups. 25 Torbey et al 22 also reported no significant differences in success rates between the Xen stand-alone group and combined cataract+Xen procedure.…”

Resultados iniciais de mundo real do XEN® 45 Gel Stent na população brasileira

“…(13) Diversos outros estudos mostraram taxas de sucesso absoluto em torno dos 70% aos 12 meses de acompanhamento. (14)(15)(16)(17)(18)(19) Alguns fatores podem ter contribuído pelas elevadas taxas de sucesso presentes no nosso estudo, mesmo no início da curva de aprendizado do cirurgião: horizonte limitado do acompanhamento (6 meses); baixo número de olhos (37); cirurgião experiente (mais de 20 anos de experiência) e com alto volume de cirurgia de glaucoma; uso de uma variante pessoal da técnica (uso de mitomicina C e agulhamento primário intraoperatório); perfil, seleção e preparo dos pacientes. Os olhos submetidos ao implante de XEN® 45 Gel Stent neste estudo eram livres de cirurgias conjuntivais prévias e foram todos submetidos a preparo conjuntival prévio à cirurgia com uso de colírio lubrificante (à base de hialuronato de sódio 0,15%) e de colírio de corticoesteroide, ambos quatro vezes por dia, por, no mínimo, 10 dias antes da cirurgia.…”

“…Apesar disso, os resultados apresentados estão em linha com outros estudos de até 5 anos de acompanhamento na literatura e têm a importância de ser a primeira avaliação de uma série de casos de mundo real do implante de XEN® 45 Gel Stent na população brasileira. (9)(10)(11)17,21) Estes achados devem ser confirmados em estudos prospectivos de longo prazo, além de serem comparados com outras opções cirúrgicas existentes para o tratamento do glaucoma.…”