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临床试验/NCT03310788
NCT03310788Unknown不适用

Monitoring of the Intraocular Pressure After Selective Laser Trabeculoplasty Using iCare Home

St. Erik Eye Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年10月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Lowering of IOP fluctuations after SLT

研究概览

简要总结

The purpose of this study is to investigate how much selective trabeculoplasty (SLT) influences intraocular pressure (IOP) fluctuations measured with iCare Home rebound tonometry (RTHome) in patients with primary open-angle glaucoma (POAG) or pseudo-exfoliation glaucoma (PEX).

详细描述

Sixty glaucoma patients (POAG and PEX) planned for SLT will be recruited.

At baseline, patients will be trained to use the iCare Home tonometer, a handheld device based on rebound tonometry and designed for patients to use at home. After the training session and when patients feel confident, a measurement will be recorded. Thereafter, a new measurement will be obtained by the study staff (an optometrist or a nurse) using the same device. No IOP values will be visible for the examiner at that point. Thereafter, a single IOP measurement will be obtained by the same study staff using Goldmann applanation tonometry (GAT). Patients will then borrow the iCare Home tonometer to meaure their IOP at 06 and 10 am, and at 2, 6 and 10 pm during three consecutive days to obtain an IOP curve. Patients will come for a second visit where new measurements will be made in the same way as at baseline.

Two months after SLT, a new IOP curve will be obtained following the same procedure as pre-operatively. Patients' daily activities (diet, motion or sleeping habits) will not be controlled.

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

  • 未提供

排除标准

  • previous SLT
  • reduced hand and arm mobility (e.g. due to rheumatism)

结局指标

主要结局

Lowering of IOP fluctuations after SLT

时间窗: 2 months

The amplitude of the IOP fluctuations pre- and post SLT will be compared

次要结局

  • Lowering of IOP level after SLT(2 months)

研究者

发起方
St. Erik Eye Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Enping Chen

MD Ph D

St. Erik Eye Hospital

研究点 (1)

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