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临床试验/NCT04888156
NCT04888156已完成不适用

Impact of Self-tonometry With iCare Home ® on Glaucoma Treatment Decision.

St. Erik Eye Hospital1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2021年5月10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
133
试验地点
1
主要终点
Clinician's choice of glaucoma treatment

研究概览

简要总结

Self-tonometry with iCare Home is performed by one hundred patients annually at Sankt Erik's Eye Hospital. The investigators want to evaluate the impact that self-tonometry results have on the clinician's choice of glaucoma treatment. The investigators also want to evaluate how often pressure peaks occur outside the clinic's opening hours.

详细描述

Since a few years back, self-tonometry has been available in glaucoma care. Self-tonometry allows patients to measure their eye pressure themselves using a portable tonometer. Sankt Erik's Eye Hospital was the first healthcare provider in Sweden to use this new technology. The investigators have previously conducted studies that have shown good agreement between the measurements made by patients and the gold standard method, e.g. Goldman applanation tonometry (GAT) (Chen, Querat et al. 2016, Querat and Chen 2017). About one hundred patients perform pressure curves with self-tonometry annually.

As the method is used regularly, the investigators want to evaluate the impact of self-tonometry results on the clinician's choice of glaucoma treatment. The investigators also want to evaluate how often pressure peaks occur outside the clinic's opening hours and how much they differ from GAT.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

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

  • Age ≥ 18 years
  • Diagnosed with POAG (primary open-angle glaucoma), PEX (pseudo-exfoliation glaucoma) or OHT (ocular hypertension)
  • Difference between patients' and staff's iCare Home® measurements less than 5 mmHg at Baseline
  • Difference between Goldman Applanation tonometry (GAT) and patient's highest iCare Home® measurements less than 7 mmHg at baseline
  • Monitoring over at least two days

排除标准

  • More than one measurement with iCare Home® tonometer below 5 mmHg
  • Missing more than one daily measurement with iCare Home® tonometer

结局指标

主要结局

Clinician's choice of glaucoma treatment

时间窗: One month

Type of treatment received by patient after performance of self-tonometry with iCare Home

次要结局

  • Occurence of IOP peaks(Three days of self-tonometry)

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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