PDF(Pubmed)
Abstract：
BACKGROUND: Minimally invasive bleb surgery using the XEN-45 gel stent has not been established for the treatment of normal-tension glaucoma (NTG). The main objective of this study was to evaluate the long-term treatment efficacy and safety of XEN-45 in eyes with uncontrolled NTG.
METHODS: A retrospective analysis of patients with NTG who underwent XEN-45 gel stent implantation at university hospital Tuebingen between 2016 and 2021. The primary outcome measure was surgical success after three years defined as lowering of intraocular pressure (IOP) of ≥ 20%, with target IOP between 6 and 15 mmHg. Success was complete without and qualified irrespective of topical antiglaucoma medication use. The need for further glaucoma surgery, except for needling, was regarded as a failure. The secondary outcome measures included changes in mean IOP, number of antiglaucoma medications, and needling and complication rates.
RESULTS: Twenty-eight eyes from 23 patients were included in the final analysis. Complete and qualified success rates were 56.5% and 75% after three years, respectively. Mean postoperative IOP ± standard deviation decreased significantly after three years from 19.3 ± 2.0 mmHg at baseline to 13.7 ± 4.2 mmHg (n = 22; p < 0.0001). The median number of antiglaucoma medications decreased from 2 (range 0-4) to 0 after three years (range 0-3; p < 0.0001). Sixteen eyes (57%) required a median of 1 (range 1-3) needling procedures. One eye required further glaucoma surgery. No sight-threatening complications were observed.
CONCLUSIONS: The XEN-45 stent is effective and safe for the long-term treatment of NTG. However, needling was frequently required to improve outcomes.
METHODS: A retrospective analysis of patients with NTG who underwent XEN-45 gel stent implantation at university hospital Tuebingen between 2016 and 2021. The primary outcome measure was surgical success after three years defined as lowering of intraocular pressure (IOP) of ≥ 20%, with target IOP between 6 and 15 mmHg. Success was complete without and qualified irrespective of topical antiglaucoma medication use. The need for further glaucoma surgery, except for needling, was regarded as a failure. The secondary outcome measures included changes in mean IOP, number of antiglaucoma medications, and needling and complication rates.
RESULTS: Twenty-eight eyes from 23 patients were included in the final analysis. Complete and qualified success rates were 56.5% and 75% after three years, respectively. Mean postoperative IOP ± standard deviation decreased significantly after three years from 19.3 ± 2.0 mmHg at baseline to 13.7 ± 4.2 mmHg (n = 22; p < 0.0001). The median number of antiglaucoma medications decreased from 2 (range 0-4) to 0 after three years (range 0-3; p < 0.0001). Sixteen eyes (57%) required a median of 1 (range 1-3) needling procedures. One eye required further glaucoma surgery. No sight-threatening complications were observed.
CONCLUSIONS: The XEN-45 stent is effective and safe for the long-term treatment of NTG. However, needling was frequently required to improve outcomes.
摘要：
背景：使用XEN-45凝胶支架的微创气泡手术尚未建立用于治疗正常眼压性青光眼（NTG）。这项研究的主要目的是评估XEN-45在非受控NTG眼中的长期治疗效果和安全性。
方法：回顾性分析2016年至2021年在Tuebingen大学医院接受XEN-45凝胶支架植入术的NTG患者。主要结果指标是手术成功三年后定义为眼内压（IOP）降低≥20％，目标IOP在6和15mmHg之间。无论使用局部抗青光眼药物，成功都是完全的，并且是合格的。需要进一步的青光眼手术，除了针刺,被视为失败。次要结果指标包括平均IOP的变化，抗青光眼药物的数量，针刺和并发症的发生率。
结果：23例患者的28只眼纳入最终分析。三年后，完全和合格的成功率分别为56.5%和75%，分别。术后平均眼压±标准差在三年后从基线时的19.3±2.0mmHg显著下降至13.7±4.2mmHg(n=22;p<0.0001)。抗青光眼药物的中位数量在三年后从2（范围0-4）降至0（范围0-3；p<0.0001）。16只眼睛（57％）需要中位数为1（范围1-3）的针刺程序。一只眼睛需要进一步的青光眼手术。未观察到危及视力的并发症。
结论：XEN-45支架对于NTG的长期治疗是有效和安全的。然而,经常需要针刺来改善结果.
方法：回顾性分析2016年至2021年在Tuebingen大学医院接受XEN-45凝胶支架植入术的NTG患者。主要结果指标是手术成功三年后定义为眼内压（IOP）降低≥20％，目标IOP在6和15mmHg之间。无论使用局部抗青光眼药物，成功都是完全的，并且是合格的。需要进一步的青光眼手术，除了针刺,被视为失败。次要结果指标包括平均IOP的变化，抗青光眼药物的数量，针刺和并发症的发生率。
结果：23例患者的28只眼纳入最终分析。三年后，完全和合格的成功率分别为56.5%和75%，分别。术后平均眼压±标准差在三年后从基线时的19.3±2.0mmHg显著下降至13.7±4.2mmHg(n=22;p<0.0001)。抗青光眼药物的中位数量在三年后从2（范围0-4）降至0（范围0-3；p<0.0001）。16只眼睛（57％）需要中位数为1（范围1-3）的针刺程序。一只眼睛需要进一步的青光眼手术。未观察到危及视力的并发症。
结论：XEN-45支架对于NTG的长期治疗是有效和安全的。然而,经常需要针刺来改善结果.
