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临床试验/NCT03164941
NCT03164941Unknown不适用

Effect of 180 Degree Selective Laser Trabeculoplasty Location on Treatment Outcomes

St. Joseph's Healthcare Hamilton1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
84
试验地点
1
主要终点
Intraocular Pressure

研究概览

简要总结

Selective Laser Trabeculoplasty (SLT) is a glaucoma treatment that has been shown to effectively lower intraocular pressure by increasing aqueous outflow through macrophage recruitment. There is evidence of increased drainage in the nasal quadrants of the eye. This study aims to compare whether there is a difference in the reduction of eye pressure when SLT is performed nasally and temporally.

详细描述

This study aims to evaluate if there is a difference between 180 degree nasal and temporal selective laser trabeculoplasty (SLT) in treatment outcomes. It is known that there is increased aqueous collectors and veins and thus aqueous drainage in the nasal quadrants of the eye. If SLT works by the hypothesized biologic mechanism in which macrophages remodel the aqueous drainage system to increase outflow, performing SLT in an area concentrated with aqueous veins may increase outflow more. As a result, we hypothesize that nasal 180 degree SLT may have better outcomes compared to the temporal counterpart. The results of this study may help inform decisions when performing 180 degree SLT and provide insight to SLT's mechanism of action. The primary objective of this study is to determine if there is a difference in treatment efficacy between nasal and temporal 180 degree SLT by measuring differences in baseline and post-operative intraocular pressures. We hypothesize that nasal SLT will have superior outcomes compared to temporal SLT due to increased number of aqueous veins.

研究设计

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

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

  • Diagnosis of open angle glaucoma, ocular hypertension, pigmentary dispersion syndrome and pseudoexfoliation syndrome
  • Participant must be over 18 years of age
  • IOP > 16mmHg on at least two consecutive occasions separated by one month
  • Two sighted eyes with visual acuity of 20/200 or better
  • Informed consent from patient

排除标准

  • Diagnosis of secondary OAG (aside from pigmentary and pseudoexfoliation glaucoma) or narrow angle glaucoma
  • Previous incisional glaucoma surgery
  • Incisional glaucoma surgery scheduled within 1 year of intervention
  • Corneal disease affecting visualization of anterior chamber of the eye
  • Treatment or plan to treat with topical or systemic steroids
  • Previous selective laser trabeculoplasty treatment

结局指标

主要结局

Intraocular Pressure

时间窗: 1 year

The primary outcome in this study is the change in intraocular pressure from baseline to the 1 year follow-up visit (continuous variable). The percentage decrease in IOP from baseline will also be calculated and compared between the two groups.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Enitan Sogbesan

Ophthalmologist

St. Joseph's Healthcare Hamilton

研究点 (1)

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