Combined and stand-alone XEN 45 gel stent implantation: 3-year outcomes and success predictors.
Gillmann Kevin, Bravetti Giorgio Enrico, Rao Harsha L, Mermoud André, Mansouri Kaweh
AI Summary
XEN gel stent implantation significantly lowered IOP and medication use at 3 years for glaucoma, despite needing frequent revisions. Identifying high-risk patients preoperatively is crucial.
Abstract
Purpose
To evaluate the 3-year treatment outcomes of XEN 45 gel stent in open-angle glaucoma patients.
Methods
In this prospective, single-centre interventional study, consecutive eyes with uncontrolled intraocular pressure (IOP) or signs of disease progression despite medical treatment underwent XEN implantation either alone or combined with phacoemulsification (Phaco + XEN).
Main outcome measures
Surgical success was defined as 'complete' when 36-month unmedicated IOP was ≤15 mmHg with a relative IOP reduction ≥ 20% from medicated baseline, while the definition of qualified success allowed no more medications than at baseline. Other definitions of success with different IOP thresholds were also analysed. Secondary outcomes included mean IOP reduction, changes in ocular hypotensive medications and rates of reoperations.
Results
Out of 149 eyes initially included, 92 eyes (61.7%) of 68 patients had complete 3-year data (XEN: n = 26; Phaco + XEN: n = 66) after 38.2% were lost to follow-up. Mean age was 76.3 ± 9.1 years, and 66.2% were female. Mean medicated IOP decreased from 20.8 ± 7.4 mmHg (21.0 ± 7.4 [XEN] vs. 20.0 ± 6.9 mmHg [Phaco + XEN]) at baseline to 13.1 ± 3.4 mmHg (12.9 ± 2.9 [XEN] vs. 12.9 ± 3.4 [Phaco + XEN]) at 3 years (-37.0%; p < 0.001). Medications decreased from 1.9 ± 1.3 (2.4 ± 1.5 [XEN] vs. 1.9 ± 1.2 [Phaco + XEN]) to 0.4 ± 0.9 (0.3 ± 0.8 [XEN] vs. 0.5 ± 0.9 [Phaco + XEN]) (-78.9%; p < 0.001). Complete success and qualified success were achieved in 29.0% and 31.0% of eyes, respectively. Needling revision was performed in 51 eyes (55.4%), and 26.1% underwent reoperations. Risk factors for surgical failure included male gender (odds ratio [OR]:3.6; p = 0.03), diagnosis of POAG (OR: 4.5; p < 0.01) and undergoing needling revision (OR: 4.6; p < 0.01). While the type of procedure had no effect on the outcomes of PEXG, POAG eyes undergoing combined surgery had significantly higher rates of failure (OR: 7.29; p = 0.023). Most patients stable at 12-month remained so through to 3 years.
Conclusions
At 3 years, XEN gel stent implantation achieved clinically significant IOP and medication reduction despite relatively high rates of needling and reoperations. Identifying patients at risk preoperatively may help optimize surgical outcomes.
MeSH Terms
Shields Classification
Key Concepts5
In a prospective, single-centre interventional study, the mean medicated intraocular pressure (IOP) in open-angle glaucoma patients who underwent XEN 45 gel stent implantation (either alone or combined with phacoemulsification) decreased from 20.8 7.4 mmHg at baseline to 13.1 3.4 mmHg at 3 years (-37.0%; p < 0.001) in 92 eyes.
In a prospective, single-centre interventional study of open-angle glaucoma patients, the number of ocular hypotensive medications decreased from 1.9 1.3 at baseline to 0.4 0.9 at 3 years (-78.9%; p < 0.001) after XEN 45 gel stent implantation (either alone or combined with phacoemulsification) in 92 eyes.
In a prospective, single-centre interventional study of open-angle glaucoma patients treated with XEN 45 gel stent implantation, complete success (36-month unmedicated IOP ≤15 mmHg with ≥20% IOP reduction from medicated baseline) was achieved in 29.0% of eyes, and qualified success (complete success with no more medications than at baseline) was achieved in 31.0% of eyes, among 92 eyes with 3-year data.
In a prospective, single-centre interventional study of open-angle glaucoma patients undergoing XEN 45 gel stent implantation, risk factors for surgical failure included male gender (odds ratio [OR]: 3.6; p = 0.03), diagnosis of POAG (OR: 4.5; p < 0.01), and undergoing needling revision (OR: 4.6; p < 0.01) among 92 eyes with 3-year data.
In a prospective, single-centre interventional study evaluating XEN 45 gel stent implantation for open-angle glaucoma, needling revision was performed in 51 eyes (55.4%) and 26.1% underwent reoperations among 92 eyes with 3-year data.
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