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临床试验/NCT03445806
NCT03445806终止不适用

IOP Monitoring After Trabeculectomy Using iCare Home

St. Erik Eye Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
50
试验地点
1
主要终点
Lowering of IOP levels after trabeculectomy

研究概览

简要总结

The purpose of this study is to investigate how much trabeculectomy 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

Fifty glaucoma patients (POAG and PEX) planned for trabeculectomy will be recruited.

At baseline, patients will be trained to use the iCare Home tonometer (RTHome), 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. At the same visit, 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. A single IOP measurement will be obtained by the same study staff using Goldmann applanation tonometry (GAT). Patients will come for a second visit where new measurements will be made in the same way as at baseline.

In between visits, patients will borrow the iCare Home tonometer to measure their IOP at 06 and 10 am, and at 2, 6 and 10 pm during three consecutive days to obtain an IOP curve.

Two-three months after trabeculectomy, a new IOP curve will be obtained following the same procedure as pre-operatively. There will be no restrictions in patients' daily activities regarding diet, physical activity or slee. If patients use any eyedrops, they will continue to use them as prescribed.

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 trabeculectomy
  • reduced hand and arm mobility (e. due to rheumatism)

结局指标

主要结局

Lowering of IOP levels after trabeculectomy

时间窗: 2-3 months

Mean (SD) IOP pre- and post trabeculectomy

次要结局

  • Lowering of IOP fluctuations after trabeculectomy(2-3 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

Principal Investigator

St. Erik Eye Hospital

研究点 (1)

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