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临床试验/NCT03187418
NCT03187418已完成不适用

Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation (mTSCPC) in Uncontrolled Glaucoma at the University of Montreal Hospital Center (CHUM)

Centre hospitalier de l'Université de Montréal (CHUM)2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2017年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
2
主要终点
Intraocular Pressure (IOP)

研究概览

简要总结

The goal of this study is to evaluate the efficacy and safety of the novel form of trans-scleral cyclophotocoagulation using micropulse diode laser and trans-pars plana treatment (Micropulse TSCPC, mTSCPC MP3, IRIDEX CYCLO G6™ Glaucoma Laser System, CA, USA) in adults for the treatment of uncontrolled glaucoma.

详细描述

Cyclophotocoagulation (CPC) is a type of cycloablation using laser to treat glaucoma. It involves ciliary body destruction by targeting the ciliary epithelium and stroma, resulting in a reduction in aqueous secretion and hence intraocular pressure. This strategy is effective for all forms of glaucoma.

Traditional trans-scleral cyclophotocoagulation (TSCPC) achieve its cyclodestructive action by using continuous diode laser to target the melanin in the pigmented ciliary body epithelium. However, the continuous mode has been shown to cause significant collateral tissue damage to adjacent non-pigmented structures including the ciliary stroma and ciliary muscle. Traditional TSCPC may therefore be associated with serious complications including uveitis, visual deterioration, chronic hypotony, and others.

More recently, a micropulse delivery mode of diode laser (Micropulse TSCPC, mTSCPC) has been used to treat glaucoma by ablating the ciliary processes and reduce aqueous humor production with more selective targeting and less collateral damage. In contrast to conventional laser delivery where a continuous flow of high intensity energy is delivered, micropulse laser application delivers a series of repetitive short pulses of energy with rest periods in between pulses. Only a few studies have described the outcomes of this novel glaucoma therapy, showing mTSCPC to have comparable efficacy with fewer side effects when compared with traditional continuous wave mode diode laser delivery.This improved side effect profile has the potential to make mTSCPC an earlier therapeutic option instead of reserving it exclusively for end-stage refractory eyes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Patients of either sex and any race aged 18 years old and above.
  • Followed by a glaucoma subspecialist at University of Montreal Hospital Center.
  • Intraocular pressure (IOP) above target and unresponsive to maximal tolerated medical therapy with or without previous surgical intervention.
  • mild glaucoma: IOP > 18 mmHg
  • moderate glaucoma: IOP > 15 mmHg
  • advanced glaucoma: IOP > 12 mmHg
  • Considered poor candidates for additional filtering surgery or implantation of glaucoma drainage devices.

排除标准

  • Patients unable to give informed consent.
  • Patients with significant scleral thinning, defined as thinning of more than one clock hour noticed on scleral transillumination.
  • Ocular infection or inflammation in the study eye in the 2 months prior to enrolment.
  • Intraocular surgery in the study eye in the 2 months prior to enrolment.

结局指标

主要结局

Intraocular Pressure (IOP)

时间窗: 18 months

In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer

次要结局

  • Mean Deviation (MD)(18 months)
  • Number of Participants With Repeat Treatments(18 months)
  • Intraocular Pressure (IOP)(1 week, 1 month, 3 months, 6 months, 12 months)
  • Pain Level During Laser Treatment(1 day)
  • Visual Field Index (VFI)(18 months)
  • Number of Intraocular Pressure Lowering Medications(1 week, 1 month, 3 months, 6 months, 12 months, 18 months)
  • Corrected Distance Visual Acuity (CDVA)(1 week, 1 month, 3 months, 6 months, 12 months, 18 months)
  • Cup-to-disc Ratio (CDR)(18 months)
  • Pattern Standard Deviation (PSD)(18 months)
  • Cup-to-disc Ratio (CDR) Assessed by Optical Coherence Tomography (OCT)(18 months)
  • Average Retinal Nerve Fiber Layer (RNFL) Thickness(18 months)
  • Average Ganglion Cell Layer (GCL) Thickness(18 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 (2)

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