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临床试验/NCT05900063
NCT05900063已完成不适用

Evaluation of the Efficacy of Selecta Laser Trabeculoplasty in Patients Undergoing Filtering Surgery

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年1月1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
75
试验地点
1
主要终点
Change of the intraocular pressure after surgery

研究概览

简要总结

Glaucoma is a common, potentially blinding pathology, threatening patients' autonomy and quality of life. The main aim of treatment is to lower intraocular pressure (IOP) in order to slow nerve fiber loss as much as possible, leading to alterations in the visual field and even reduced visual acuity. To achieve this drop in pressure, there are, of course, hypotonizing eye drops, trabeculoplasty with Laser Selecta (SLT) or filtering surgery (trabeculectomy, deep non-perforating sclerectomy, insertion of drainage devices). Laser Selecta specifically targets pigmented trabecular meshwork cells without damaging adjacent structures, and is thought to act via three mechanisms: distension of Schlemm's canal, reorganization of trabecular meshwork cells and stimulation of extracellular matrix production. Its efficacy has been demonstrated in several studies, with a 20-30% reduction in intraocular pressure in patients who have never undergone surgery. Few studies have investigated the efficacy of SLT in patients who have already undergone filtering surgery. The aim of this study is therefore to determine the efficacy of SLT in previously operated patients whose intraocular pressure remains insufficiently controlled.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Patients aged ≥ 18 years
  • Patients who have undergone filtering surgery such as trabeculectomy, deep non-perforating sclerectomy, or placement of a Xen®-type device
  • Patients who have undergone laser SLT
  • Patient with primary open-angle glaucoma, exfoliative glaucoma or pigmentary glaucoma
  • Insufficiently controlled intraocular pressure.

排除标准

  • Patients under guardianship or curatorship
  • Patient deprived of liberty
  • Patient objecting to the use of his or her data for this research
  • Patient with angle-closure glaucoma
  • Patient having undergone any other type of eye surgery except cataract surgery

结局指标

主要结局

Change of the intraocular pressure after surgery

时间窗: 12 months

Intraocular pressure is measured before procedure , 1 month, 6months and 12 months after procedure

次要结局

  • Average change of the intraocular pressure after procedure depending on the type of filtering surgery(12 months)
  • Average change of the intraocular pressure after procedure depending of the initial IOP(12 months)
  • Average change of the intraocular pressure after procedure depending on the delay between filtering surgery and the Selecta Laser procedure.(12 months)
  • Average change of the intraocular pressure after procedure depending on the type of glaucoma(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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