Abstract
PurposeTo assess the 3‐year effectiveness and safety of the XEN gel stent implanted ab interno in open‐angle glaucoma (OAG).MethodsThis 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.ResultsThe 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.ConclusionThe 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.
Highlights
Glaucoma is the leading cause of irreversible blindness worldwide and is considered a global medical challenge (American Academy of Ophthalmology 2020; European Glaucoma Society 2020)
Data were collected from 174 consecutive patients (212 eyes with open-angle glaucoma (OAG)); 38 (21.8%) patients had received the gel stent in both eyes
White/Caucasian, and 73.6% were diagnosed with primary open-angle glaucoma (POAG) (Table 1)
Summary
Glaucoma is the leading cause of irreversible blindness worldwide and is considered a global medical challenge (American Academy of Ophthalmology 2020; European Glaucoma Society 2020). Invasive glaucoma surgery (MIGS) devices (Caprioli et al 2015) are an important part of the glaucoma treatment armamentarium. The gel stent (XENÒ45 Glaucoma Treatment System, Allergan, an AbbVie company, North Chicago, IL) is a less invasive surgical device that facilitates subconjunctival drainage similar to trabeculectomy. The stent is a 6-mm-long gelatin tube (Allergan 2016; Vera & Horvath 2014) with a 45-μm lumen that connects the anterior chamber to the subconjunctival space. In Europe, the gel stent is indicated for the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) where previous medical treatments have failed (Allergan 2016). While previously published studies have shown effectiveness and safety of the gel stent at 2 years (single- and multicentre studies) (Gillmann et al 2019; Reitsamer et al 2019; Gabbay et al 2020; Gillmann et al 2020b) and 3 years (single-centre study) (Gillmann et al 2020a), this is the first multicentre study to report 3-year effectiveness and safety of the 45-μm gel stent in clinical settings
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