Jeremy C.K. Tan MD, FRANZCO , Yohei Hashimoto MD, PhD , Pierre Henry Gabrielle PhD , Catherine Creuzot Garcher MD, PhD , Andrew White PhD, FRANZCO , Hamish Dunn MBBS, FRANZCO , Mark Walland FRANZCO, FRACS , David Wechsler MBBS, FRANZCO , Louis Arnould MD, PhD , Mitchell Lawlor PhD, FRANZCO
{"title":"初级独立 Xen45 凝胶支架与小梁切除术治疗青光眼失败的结果和基线预测因素。","authors":"Jeremy C.K. Tan MD, FRANZCO , Yohei Hashimoto MD, PhD , Pierre Henry Gabrielle PhD , Catherine Creuzot Garcher MD, PhD , Andrew White PhD, FRANZCO , Hamish Dunn MBBS, FRANZCO , Mark Walland FRANZCO, FRACS , David Wechsler MBBS, FRANZCO , Louis Arnould MD, PhD , Mitchell Lawlor PhD, FRANZCO","doi":"10.1016/j.ogla.2024.07.002","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose</h3><div>To compare safety, effectiveness, and baseline predictors of failure in standalone primary Xen45 gel stent (Xen) versus trabeculectomy (Trab) in glaucoma.</div></div><div><h3>Design</h3><div>Retrospective study.</div></div><div><h3>Subjects</h3><div>Subjects that underwent primary Xen or Trab augmented by mitomycin-C with at least 12 months follow-up.</div></div><div><h3>Methods</h3><div>Multinational observational study of eyes in the Fight Glaucoma Blindness international registry</div></div><div><h3>Main Outcome Measures</h3><div>The primary outcome was success at 12 months defined by intraocular pressure (IOP) reduction ≥ 20% from baseline and ≤ threshold IOPs of 15, 18, and 21 mmHg with (qualified) or without (complete) medications and without secondary glaucoma surgery. Multivariable mixed effects Cox regression models were used to identify risk factors for failure in each cohort.</div></div><div><h3>Results</h3><div>A total of 701 eyes (Xen, 308; Trab, 393) of 596 subjects were included with baseline IOP being significantly higher (22.4 vs. 19.9 mmHg, <em>P</em> < 0.001) and baseline medications significantly lower in the Xen versus the Trab group (2.9 vs. 3.4, <em>P</em> < 0.001). Baseline visual field mean deviation was less severe in the Xen group (–9.47 vs. –13.04 dB, <em>P</em> < 0.001). The proportion of complete surgical success was significantly lower in the Xen versus Trab group across the 3 upper IOP limits at 12 months; 32% versus 52% at 15 mmHg, 37% versus 54% at 18 mmHg, and 39% versus 55% at 21 mmHg (<em>P</em> < 0.001). The incidence of postoperative numerical and symptomatic hypotony was lower in the Xen versus Trab group. In the Xen cohort, a higher failure rate was associated with Asian ethnicity (hazard ratio [HR], 1.97; 95% confidence interval (CI), 1.03–3.79) and use of oral acetazolamide at baseline (HR, 1.74; 95% CI, 1.13–2.70), whereas a lower failure rate was associated with diagnosis of ocular hypertension/open-angle glaucoma suspect (HR, 0.40; 95% CI, 0.20–0.82) and secondary open-angle glaucoma (HR, 0.46; 95% CI, 0.26–0.82). Exposure to prostaglandin analog was associated with greater failure in the Trab group (HR, 2.66; 95% CI, 1.18–6.01).</div></div><div><h3>Conclusions</h3><div>There was significantly greater complete success at 12 months across all complete success definitions for Trab compared with Xen, whereas the rate of postoperative hypotony was significantly lower in the Xen group. Asian ethnicity and use of oral acetazolamide at baseline were associated with greater failure in Xen, whereas exposure to prostaglandin analog was associated with greater failure in Trab patients. Such baseline predictors of success and failure may help guide patient selection for subconjunctival minimally invasive glaucoma surgery in patients undergoing surgical intervention.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":19519,"journal":{"name":"Ophthalmology. Glaucoma","volume":"7 6","pages":"Pages 539-550"},"PeriodicalIF":2.8000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Outcomes and Baseline Predictors of Failure in Primary Standalone Xen45 Gel Stent versus Trabeculectomy for Glaucoma\",\"authors\":\"Jeremy C.K. Tan MD, FRANZCO , Yohei Hashimoto MD, PhD , Pierre Henry Gabrielle PhD , Catherine Creuzot Garcher MD, PhD , Andrew White PhD, FRANZCO , Hamish Dunn MBBS, FRANZCO , Mark Walland FRANZCO, FRACS , David Wechsler MBBS, FRANZCO , Louis Arnould MD, PhD , Mitchell Lawlor PhD, FRANZCO\",\"doi\":\"10.1016/j.ogla.2024.07.002\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Purpose</h3><div>To compare safety, effectiveness, and baseline predictors of failure in standalone primary Xen45 gel stent (Xen) versus trabeculectomy (Trab) in glaucoma.</div></div><div><h3>Design</h3><div>Retrospective study.</div></div><div><h3>Subjects</h3><div>Subjects that underwent primary Xen or Trab augmented by mitomycin-C with at least 12 months follow-up.</div></div><div><h3>Methods</h3><div>Multinational observational study of eyes in the Fight Glaucoma Blindness international registry</div></div><div><h3>Main Outcome Measures</h3><div>The primary outcome was success at 12 months defined by intraocular pressure (IOP) reduction ≥ 20% from baseline and ≤ threshold IOPs of 15, 18, and 21 mmHg with (qualified) or without (complete) medications and without secondary glaucoma surgery. Multivariable mixed effects Cox regression models were used to identify risk factors for failure in each cohort.</div></div><div><h3>Results</h3><div>A total of 701 eyes (Xen, 308; Trab, 393) of 596 subjects were included with baseline IOP being significantly higher (22.4 vs. 19.9 mmHg, <em>P</em> < 0.001) and baseline medications significantly lower in the Xen versus the Trab group (2.9 vs. 3.4, <em>P</em> < 0.001). Baseline visual field mean deviation was less severe in the Xen group (–9.47 vs. –13.04 dB, <em>P</em> < 0.001). The proportion of complete surgical success was significantly lower in the Xen versus Trab group across the 3 upper IOP limits at 12 months; 32% versus 52% at 15 mmHg, 37% versus 54% at 18 mmHg, and 39% versus 55% at 21 mmHg (<em>P</em> < 0.001). The incidence of postoperative numerical and symptomatic hypotony was lower in the Xen versus Trab group. In the Xen cohort, a higher failure rate was associated with Asian ethnicity (hazard ratio [HR], 1.97; 95% confidence interval (CI), 1.03–3.79) and use of oral acetazolamide at baseline (HR, 1.74; 95% CI, 1.13–2.70), whereas a lower failure rate was associated with diagnosis of ocular hypertension/open-angle glaucoma suspect (HR, 0.40; 95% CI, 0.20–0.82) and secondary open-angle glaucoma (HR, 0.46; 95% CI, 0.26–0.82). Exposure to prostaglandin analog was associated with greater failure in the Trab group (HR, 2.66; 95% CI, 1.18–6.01).</div></div><div><h3>Conclusions</h3><div>There was significantly greater complete success at 12 months across all complete success definitions for Trab compared with Xen, whereas the rate of postoperative hypotony was significantly lower in the Xen group. Asian ethnicity and use of oral acetazolamide at baseline were associated with greater failure in Xen, whereas exposure to prostaglandin analog was associated with greater failure in Trab patients. Such baseline predictors of success and failure may help guide patient selection for subconjunctival minimally invasive glaucoma surgery in patients undergoing surgical intervention.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>\",\"PeriodicalId\":19519,\"journal\":{\"name\":\"Ophthalmology. Glaucoma\",\"volume\":\"7 6\",\"pages\":\"Pages 539-550\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Ophthalmology. 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引用次数: 0
摘要
目的:比较独立初级Xen45凝胶支架(Xen)与小梁切除术(Trab)治疗青光眼的安全性、有效性和失败的基线预测因素:设计:回顾性研究:随访至少12个月并接受Xen或Trab术后丝裂霉素-C辅助治疗的受试者:主要结果测量:主要结果是 12 个月时的成功率,定义为眼压较基线降低≥ 20%,且眼压≤ 15mmHg、18mmHg 和 21mmHg 临界值,有(合格)或无(完全)药物治疗,且未进行二次青光眼手术。多变量混合效应考克斯回归模型用于确定每个队列中失败的风险因素:596名受试者中有701只眼睛(Xen组,308只;Trab组,393只)入选,Xen组与Trab组相比,基线眼压明显更高(22.4 mmHg vs 19.9 mmHg,p < 0.001),基线用药明显更少(2.9 mmHg vs 3.4 mmHg,p 结论:Xen组与Trab组相比,基线用药明显更少(2.9 mmHg vs 3.4 mmHg,p < 0.001):在所有完全成功定义中,Trab组在12个月时的完全成功率明显高于Xen组,而Xen组的术后低张力率明显低于Trab组。亚裔和基线使用口服乙酰唑胺与 Xen 的更大失败率相关,而前列腺素类似物与 Trab 患者的更大失败率相关。这些成功和失败的基线预测因素有助于指导接受手术干预的患者选择结膜下微创青光眼手术。
Outcomes and Baseline Predictors of Failure in Primary Standalone Xen45 Gel Stent versus Trabeculectomy for Glaucoma
Purpose
To compare safety, effectiveness, and baseline predictors of failure in standalone primary Xen45 gel stent (Xen) versus trabeculectomy (Trab) in glaucoma.
Design
Retrospective study.
Subjects
Subjects that underwent primary Xen or Trab augmented by mitomycin-C with at least 12 months follow-up.
Methods
Multinational observational study of eyes in the Fight Glaucoma Blindness international registry
Main Outcome Measures
The primary outcome was success at 12 months defined by intraocular pressure (IOP) reduction ≥ 20% from baseline and ≤ threshold IOPs of 15, 18, and 21 mmHg with (qualified) or without (complete) medications and without secondary glaucoma surgery. Multivariable mixed effects Cox regression models were used to identify risk factors for failure in each cohort.
Results
A total of 701 eyes (Xen, 308; Trab, 393) of 596 subjects were included with baseline IOP being significantly higher (22.4 vs. 19.9 mmHg, P < 0.001) and baseline medications significantly lower in the Xen versus the Trab group (2.9 vs. 3.4, P < 0.001). Baseline visual field mean deviation was less severe in the Xen group (–9.47 vs. –13.04 dB, P < 0.001). The proportion of complete surgical success was significantly lower in the Xen versus Trab group across the 3 upper IOP limits at 12 months; 32% versus 52% at 15 mmHg, 37% versus 54% at 18 mmHg, and 39% versus 55% at 21 mmHg (P < 0.001). The incidence of postoperative numerical and symptomatic hypotony was lower in the Xen versus Trab group. In the Xen cohort, a higher failure rate was associated with Asian ethnicity (hazard ratio [HR], 1.97; 95% confidence interval (CI), 1.03–3.79) and use of oral acetazolamide at baseline (HR, 1.74; 95% CI, 1.13–2.70), whereas a lower failure rate was associated with diagnosis of ocular hypertension/open-angle glaucoma suspect (HR, 0.40; 95% CI, 0.20–0.82) and secondary open-angle glaucoma (HR, 0.46; 95% CI, 0.26–0.82). Exposure to prostaglandin analog was associated with greater failure in the Trab group (HR, 2.66; 95% CI, 1.18–6.01).
Conclusions
There was significantly greater complete success at 12 months across all complete success definitions for Trab compared with Xen, whereas the rate of postoperative hypotony was significantly lower in the Xen group. Asian ethnicity and use of oral acetazolamide at baseline were associated with greater failure in Xen, whereas exposure to prostaglandin analog was associated with greater failure in Trab patients. Such baseline predictors of success and failure may help guide patient selection for subconjunctival minimally invasive glaucoma surgery in patients undergoing surgical intervention.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.