iCare® Home vs Goldmann Applanation Tonometry

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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma; Open Angle Glaucoma; Pseudo Exfoliation Syndrome
• Intervention / Treatment: Device: Intraocular pressure measurments

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11282
    • St Erik Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients who are referred to the clinic to perform a Eye pressure curve with iCare® Home are offered to participate in the study. The patient him-/herself or someone accompanying him/her may perform the measurements. Volunteer without an eye history to participate.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between iCare® Home inter-user measurements	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	12 months
Correlation between GAT measurements made by different healthcare personnel	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between iCare® Home tonometry and GAT	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).	12 months

Collaborators and Investigators

• Sponsor: St. Erik Eye Hospital
• Investigators: Principal Investigator: Enping Chen, MD Ph D, St. Erik Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: intraocular pressure; self-tonometry; rebound tonometry; GAT; iCare® Home
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Iris Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Exfoliation Syndrome
• Other Study ID Numbers: iCare Home vs GAT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No