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Implantation de l'implant XEN 45 Gel Stent dans le glaucome à angle ouvert : résultats à 5 ans d'une étude prospective

To evaluate 5-year treatment outcomes of XEN gel stent implantation in patients with open-angle glaucoma. 

In this prospective, single-center interventional study, XEN implantation either alone or combined with phacoemulsification (Phaco + XEN) was performed on consecutive eyes with uncontrolled intraocular pressure (IOP) or disease progression despite medical treatment. Surgical success was defined as ’complete’ when 60-month unmedicated IOP was ≤15 mmHg with a relative IOP reduction ≥ 20% from medicated baseline. At the same time, the definition of qualified success allowed no more medications than at baseline. Secondary outcomes included mean IOP reduction, changes in ocular hypotensive medications, and rates of reoperations.

Out of 170 eyes initially included, 80 eyes (53.7%) of 68 patients completed the 5-year follow-up and were included in the data (XEN: n = 17; Phaco + XEN: n = 63) after 46.3% were lost to follow-up. The mean age was 78.1 &plusmn; 9.1 years, and 69.8% were female. Mean medicated IOP decreased from 19.8 &plusmn; 7.0 mmHg (19.9 &plusmn; 7.8 [XEN] vs. 20.1 &plusmn; 7.6 mmHg [Phaco + XEN]) at baseline to 12.6 &plusmn; 3.1 mmHg (12.6&plusmn; 3.1 [XEN] vs. 12.7 &plusmn; 3.1 [Phaco + XEN]) at 5 years (&plusmn;37.0%; p < 0.001). Medications decreased from 2.0 &plusmn; 1.3 (2.0 &plusmn; 1.3 [XEN] vs. 2.0 &plusmn; 1.3 [Phaco + XEN]) to 0.8 &plusmn; 0.5 (0.8 &plusmn; 1.1 [XEN] vs. 0.8 &plusmn; 1.1 [Phaco + XEN]) (&plusmn;60%; p < 0.001). Needling revision was performed in 39 eyes (49%), and 19.4% underwent reoperations. 

At 5 years, XEN 45 gel stent implantation achieved clinically significant IOP and medication reduction. The procedure carries a substantial rate of needling and re-operations. The study was limited by a significant number of patients lost to follow-up. 

Xen 45 Gel Stent remains effective at 5-years with an acceptable safety profile.