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临床试验/NCT05201378
NCT05201378已完成不适用

Deep Sclerectomy vs Xen in Solo Procedure: Comparative Study, Efficacy and Safety Profile

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2021年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
282
试验地点
1
主要终点
Rate of surgical success at last visit in both groups

研究概览

简要总结

Glaucoma is the leading cause of irreversible blindness in the world and the second leading cause of blindness after cataract after the age of 50. Lowering intraocular pressure (IOP) is the only treatment option to prevent visual field degradation. While medical treatment and selective laser trabeculoplasty are considered first-line options in open-angle glaucoma, the surgical option is considered in patients who have uncontrolled IOP under maximal tolerated medical treatment. In this situation, trabeculectomy or deep nonperforating sclerectomy may be performed. Although it is uncertain whether SPNP is superior to trabeculectomy, which is considered the gold standard of surgery, SPNP is a procedure that offers a better quality of life and fewer intra- and postoperative complications. SPNP was first described by Zimmerman. It consists in peeling off the internal wall of Schlemm's canal and the juxta-canalicular trabeculum which represent the main resistances to the evacuation of the aqueous humor. The trabecular meshwork is left intact and acts as a filter membrane between the subconjunctival space and the anterior chamber. The addition of mitomycin (MMC) is necessary because it is associated with better IOP control and greater surgical success. Although postoperative procedures such as needling or Nd:YAG laser-assisted gonioponctures are often required, SPNP offers good long-term results in patients who are naïve to any filtering surgery.

Minimally invasive surgery has been used more and more over the last 10 years. It aims to reduce surgical complications in comparison to classical filtering procedures while respecting the eye's own anatomy. Several devices have been invented to increase aqueous humor elimination. They can be implanted ab-interno or ab-externo and can be implanted in the suprachoroidal space, in Schlemm's canal or in the subconjunctival space. The XEN gelstent (Allergan, Dublin, Ireland) is placed ab-interno between the subconjunctival space and the anterior chamber, either in combination with cataract surgery or as a solo procedure.

The aim of the study is to compare the surgical success of these 2 techniques. No study has ever compared these 2 surgeries in solo procedure. A recent retrospective trial compared them in combined procedures without showing significant differences in IOP reduction. Nevertheless, the short follow-up period of 9 months may have been insufficient to show a real difference.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient whose age ≥ 18 years
  • Patient with primary or secondary open angle glaucoma
  • Patient who has undergone a SPNP or XEN procedure in solo
  • French speaking patient

排除标准

  • Angle closure
  • Less than 6 months follow-up
  • History of eye filtering surgery included
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his/her data for this research

结局指标

主要结局

Rate of surgical success at last visit in both groups

时间窗: through study completion, an average of 6 months

This outcome corresponds to intraocular pressure assessed at last visit, an average of 6 months.

次要结局

  • number of antiglaucoma medications(through study completion, an average of 6 months)
  • Intra- and postoperative complications(through study completion, an average of 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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