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临床试验/NCT04602923
NCT04602923已完成不适用

Comparison of Keratometric Change After Xen Gel Stent Implantation, Trabeculectomy, and Tube Shunts

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年11月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Keratometric values (OPD-Scan)

研究概览

简要总结

The main goal of this study is to assess the severity of postoperative corneal astigmatism induced by implantation of the XEN Gel Stent compared to that induced by traditional filtering surgery (trabeculectomy and GDDs). Corneal astigmatism can be assessed using corneal topography, a non-invasive tool which provides an accurate estimate of corneal curvature in all meridians. To the best of our knowledge, no study has yet attempted to quantify the amount of astigmatism induced by the XEN Gel Stent.

详细描述

Following glaucoma surgery, patients often experience decreased visual acuity (VA) which can partly be explained by induced changes to the optical properties of the cornea. Corneal astigmatism can be assessed using corneal topography, a non-invasive tool which provides an accurate estimate of corneal curvature in all meridians. Obtained keratometric measures (termed K values) can allow clinicians to quantify the amount of astigmatism before and after surgical intervention.

Multiple studies have been previously published to evaluate induced postoperative astigmatism after trabeculectomy. However, only two studies have characterized the impact of GDDs on keratometric values. To the best of our knowledge, no study has yet attempted to quantify the amount of astigmatism induced by the XEN Gel Stent.

Assessing the impact of the XEN implant on corneal astigmatism is important to better characterize the expected course of postoperative visual rehabilitation, the impact of novel glaucoma devices on corneal properties and the predictability of refractive outcomes after XEN implantation. Compared to traditional filtering surgery, the XEN Gel Stent is inserted without opening the conjunctiva and is implanted further from the corneal limbus (5 mm). These factors may allow for a reduced amount of surgically induced corneal astigmatism.

We hypothesize that the XEN Gel Stent implantation induces less corneal astigmatism compared to traditional filtering surgery, such as the trabeculectomy and GDDs (BGI or AGV).

The main goal of this prospective interventional comparative study is to assess the severity of postoperative corneal astigmatism induced by implantation of the XEN Gel Stent compared to that induced by traditional filtering surgery (trabeculectomy and GDDs).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Eyes with an IOP above target and/or progressing on maximally tolerated medical therapy;
  • •Patients aged 18 years or older;
  • •Ability to provide informed consent;
  • •Ability to be followed for the entire duration of the study.

排除标准

  • •Patients less than 18 years old;
  • •Inability to provide informed consent;
  • •Inability to be followed for the entire duration of the study;
  • •Patients undergoing surgery combined with cataract extraction;
  • •Presence of severe dry eye disease;
  • •Presence of ocular comorbidities other than glaucoma, such as corneal or retinal disease.

研究组 & 干预措施

XEN Gel Stent implantation

Experimental

Participants suffering from glaucoma who are candidates for XEN Gel Stent implantation

干预措施: Corneal topography: OPD-Scan (Diagnostic Test)

XEN Gel Stent implantation

Experimental

Participants suffering from glaucoma who are candidates for XEN Gel Stent implantation

干预措施: Corneal topography: Pentacam (Diagnostic Test)

Trabeculectomy

Experimental

Participants suffering from glaucoma who are candidates for trabeculectomy

干预措施: Corneal topography: OPD-Scan (Diagnostic Test)

Trabeculectomy

Experimental

Participants suffering from glaucoma who are candidates for trabeculectomy

干预措施: Corneal topography: Pentacam (Diagnostic Test)

GDD implantation

Experimental

Participants suffering from glaucoma who are candidates for GDD implantation (BGI or AGV)

干预措施: Corneal topography: OPD-Scan (Diagnostic Test)

GDD implantation

Experimental

Participants suffering from glaucoma who are candidates for GDD implantation (BGI or AGV)

干预措施: Corneal topography: Pentacam (Diagnostic Test)

结局指标

主要结局

Keratometric values (OPD-Scan)

时间窗: Baseline, 2 months, 6 months, 12 months

Change in simulated keratometric (K) values obtained by OPD-Scan between the indicated timepoints.

Keratometric values (Pentacam)

时间窗: Baseline, 2 months, 6 months, 12 months

Change in simulated keratometric (K) values obtained by Pentacam between the indicated timepoints.

次要结局

  • Intraocular pressure change(Baseline, 2 months, 6 months, 12 months)
  • Visual field change change(Baseline, 6 months, 12 months)
  • Retinal nerve fiber layer thickness change(Baseline, 6 months, 12 months)
  • Best-corrected visual acuity change(Baseline, 2 months, 6 months, 12 months)
  • Ganglion cell layer thickness change(Baseline, 6 months, 12 months)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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