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OpenTrials
Completed

NCT Number: NCT04911387

iCare® Home vs Goldmann Applanation Tonometry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Erik Eye Hospital

Stockholm, 11282, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Intraocular pressure measurments

Device

Intraocular pressure measurements with iCare Home by participants (patients, volunteers) and healthcare staff as well as intraocular pressure measurements with GAT by participants different healthcare staff.

Primary outcomes

  1. Correlation between iCare® Home inter-user measurements

    Time frame: 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

  2. Correlation between GAT measurements made by different healthcare personnel

    Time frame: 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

Secondary outcomes

  1. Agreement between iCare® Home tonometry and GAT

    Time frame: 12 months

    Agreement, repeatability and reliability of measurements made with iCare® Home tonometry and GAT will be assessed using Bland Altman analysis, ANOVA and interclass correlation coefficient (ICC).

Sponsors and collaborators

Lead sponsor

St. Erik Eye Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 3, 2021
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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