Intraocular Pressure and Medication Changes Associated with Xen Gel Stent: A Systematic Review of the Literature

Abstract

The Xen gel stent (Allergan Inc, an AbbVie company; Dublin, Ireland) was conceived as an option for patients requiring modest IOP reduction but for whom trabeculectomy was not yet indicated. As with any glaucoma surgery, establishing criteria for patient selection and identifying factors that contribute to a high likelihood of success are important. To help guide clinical decisionmaking, a systematic review of published studies on the gel stent was performed, with the goal of understanding postoperative outcomes based on clinical and patient factors. Results were organized around a series of pertinent clinical questions based on scenarios encountered in clinical practice. Criteria for including studies were intentionally broad, with the objective of simulating the diverse population of glaucoma patients encountered in real-world practice. Outcomes for IOP and medication reduction postoperatively were assessed in various analyses, including in eyes with various glaucoma types and severity; in eyes naïve to surgery as well as those with a history of prior incisional glaucoma surgery; and when surgery was performed as a standalone procedure or at the time of cataract surgery. The results of each of the various analyses were consistent in demonstrating that successful gel stent surgery achieved a postoperative IOP of approximately 14.0 mm Hg and reduction to fewer than 1 glaucoma medication. Additional data are shown on outcomes by method of implant (ab interno vs ab externo); intraoperative use of antifibrotics; and rates of needling in published studies.

Effectiveness and Safety of Xen Gel Stent in Glaucoma Surgery: A Systematic Review of the Literature

“…Similarly, Yang et al [ 103 ], in a systematic review and metanalysis, did not find significant differences between XEN and phaco-XEN surgery in terms of IOP after surgery (standardized mean difference: −0.01, 95% CI −0.09 to 0.08, p value 0.894). Nevertheless, the reduction in the number of ocular hypotensive medications was greater in the XEN solo group ( p = 0.019) [ 102 ].…”

“…Similarly, Yang et al [ 102 ] did not find significant differences in IOP lowering between XEN-solo and XEN + Phaco (standardized mean difference: −0.01, 95% CI −0.09 to 0.08, p value 0.894). Moreover, Panarelli et al [ 103 ] reported that, on average, successful gel stent surgery achieved a postoperative IOP of approximately 14.0 mm Hg and reduction to fewer than 1 ocular hypotensive medication.…”

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

“…Apesar do número reduzido de olhos e, também, pelo fato de esta série ter sido constituída pelos primeiros olhos submetidos ao procedimento pelo cirurgião, o resultado encontrado é bastante similar ao encontrado por análise conjunta de um grupo de estudos, realizado por Panarelli et em metanálise recente. (9) Eles encontraram uma redução média absoluta da PIO de 6,6 mmHg para o mesmo tempo de acompanhamento pós-operatório. (9) Isso demonstra que, mesmo no início da curva de aprendizado, é possível alcançar resultados semelhantes ao encontrados na literatura.…”

“…A técnica cirúrgica usa habitualmente uma abordagem ab interna, sem a necessidade de abertura conjuntival e nem de suturas. (8,9) Esse implante já é de uso corrente nos principais países da Europa, da Ásia e da América do Norte há aproximadamente uma década, contudo, só foi disponibilizado para o mercado brasileiro no começo de 2023.…”

“…A experiência clínica e a literatura científica global demonstram reduções significativas da PIO e da necessidade de colírios hipotensores oculares com uso do XEN® 45 Gel Stent, enquanto é elevado o perfil de segurança. (9)(10)(11)(12) Não há publicações do uso do XEN® 45 Gel Stent na população brasileira.…”