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临床试验/NCT02628223
NCT02628223已完成不适用

A Randomized Trial of 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma

Temple University4 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
4
主要终点
Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up

研究概览

简要总结

Selective laser trabeculoplasty (SLT) is a well-recognized way to lower eye pressure in treatment of glaucoma. This treatment is performed for 180 degrees or 360 degrees, and studies at academic centers have shown mixed results when comparing the success rates of 180 degrees or 360 degrees. Both protocols are now typically done by comprehensive ophthalmologists. However, there is no data that compares success rates of 180 degrees and 360 degrees in the community setting.

详细描述

This study is designed as a prospective evaluation of the two treatment algorithms for SLT by measuring intraocular pressure (IOP) after treatment. The hypothesis is that 360 degrees of SLT will produce a greater reduction in IOP than 180 degrees of SLT at 3 months follow up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

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 who have been diagnosed with open-angle glaucoma including ocular hypertension, pseudoexfoliation and pigment dispersion syndrome
  • greater than 18 years of age
  • initial intraocular pressure (IOP) of ≥ 21 mmHg

排除标准

  • prior medical or laser therapy to lower IOP
  • previous incisional glaucoma surgery before the study period

结局指标

主要结局

Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up

时间窗: 3 months

Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at three months of follow-up

次要结局

  • Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at 1 Year of Follow-up(1 year)
  • Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Time at Which Additional Glaucoma Therapy is Required(within 1 year of study intervention)
  • Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Last Follow-up(within 1 year of study intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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