Three‐year effectiveness and safety of the XEN gel stent as a solo procedure or in combination with phacoemulsification in open‐angle glaucoma: a multicentre study

PURPOSE: To assess the 3‐year effectiveness and safety of the XEN gel stent implanted ab interno in open‐angle glaucoma (OAG). METHODS: This study was a multicentre, retrospective chart review of consecutive patients with OAG who underwent ab‐interno gel stent placement alone or combined with phacoemulsification between 1 January 2014 and 1 October 2015. Outcome measures included mean changes in intraocular pressure (IOP) and IOP‐lowering medication count from medicated baseline at 1, 2, 3 (primary outcome) and 4 years (if available) postimplantation. Intraoperative complications, adverse events of special interest (AESIs) and secondary surgical interventions (SSIs) were recorded. RESULTS: The safety and effectiveness populations included 212 eyes (primary and secondary) and 174 eyes (primary), respectively. Mean IOP and medication decreased from 20.7 mmHg and 2.5 at baseline (n = 163 primary/first implanted eyes) to 13.9 mmHg and 1.1 medications (n = 76) at 3 years postimplantation, respectively. Mean changes from baseline in IOP (−5.6, −6.2 and −6.6 mmHg) and IOP‐lowering medication count (−1.8, −1.6 and −1.4) were statistically significant at 1, 2 and 3 years postimplantation, respectively. Results appeared comparable when implantation was performed with (n = 76) or without (n = 98) phacoemulsification. In primary eyes with 4‐year IOP and medication count data (n = 27), mean IOP was 14.0 mmHg on 1.3 medications at 4 years postimplantation. Fifteen (7.1%) eyes had intraoperative complications, 31 (14.6%) experienced 46 postoperative AESIs, and 26 (12.3%) required SSI. CONCLUSION: The gel stent effectively lowered IOP and IOP‐lowering medication count over 3 years, with a predictable and acceptable safety profile, when implanted via the traditional ab‐interno technique.