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临床试验/NCT04911387
NCT04911387已完成不适用

iCare® Home vs Goldmann Applanation Tonometry: Agreement of the Methods and Comparison of Inter-observer Variation at a Tertiary Eye Centre

St. Erik Eye Hospital1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2020年4月1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
61
试验地点
1
主要终点
Correlation between iCare® Home inter-user measurements

研究概览

简要总结

Self-tonometry with iCare Home is regularly performed at Sankt Erik's Eye Hospital since a few years back. The purpose of this study was to show that the eye pressure measurements made with iCare® Home by patients / relatives do not vary more than those made with the standard method, Goldman applanation tonometry (GAT), by different healthcare professionals. This will hopefully confirm the usefulness of self-tonometry.

详细描述

Since a few years back, self-tonometry with iCare® Home has been available in glaucoma care. Sankt Erik's Eye Hospital was first in Sweden to use the new technology. Several studies have shown good agreement between measurements made by patients or healthcare professionals with iCare® Home and Goldman applanation tonometry (GAT). However, some researchers raise critical voices about the reliability of iCare® Home measurements because they can differ from GAT. GAT is considered the gold standard method of tonometry to which all other instruments are compared. But like all other methods, GAT has some limitations.

At the clinic, the eye pressure is usually measured with GAT by different staff (ophthalmological nurses, opticians or doctors) from visit to visit. This can sometimes lead to pressure variations that may affect the follow-up of glaucoma patients. This raises the question of whether the difference between GAT and iCare® Home is statistically and clinically significant.

The purpose of this study was to show that the eye pressure measurements made with iCare® Home by patients / relatives do not vary more than those made with the standard method GAT by different healthcare professionals. This will hopefully confirm the usefulness of self-tonometry.

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

  • primary open angle glaucoma (POAG)
  • pseudo-exfoliation glaucoma (PEX)
  • ocular hypertension (OHT)
  • no eye disease,

排除标准

  • inability to perform measurements due to limited hand or arm mobility (eg rheumatism, tremor)
  • measurements outside the iCare® Home manufacturer's recommendations.

结局指标

主要结局

Correlation between iCare® Home inter-user measurements

时间窗: 12 months

iCare® Home measurements made by participants (patients and volunteers) will be compared to iCare® Home measurements made by trainers' using the same device on the same occasion

Correlation between GAT measurements made by different healthcare personnel

时间窗: 12 months

GAT measurements made by iCare® Home trainers will be compared to GAT measurements made by other available healthcare personnel using a different device on the same occasion

次要结局

  • Agreement between iCare® Home tonometry and GAT(12 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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