iCare® Home vs Goldmann Applanation Tonometry

Completed

• Conditions: Open Angle Glaucoma; Ocular Hypertension; Glaucoma; Pseudo Exfoliation Syndrome

• Registration Number: NCT04911387
• Lead Sponsor: St. Erik Eye Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2020-04-01
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Status Verified: 2021-05
• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-27
• Last Update Submitted: 2021-05-27
• Study First Posted: 2021-06-03
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between iCare® Home inter-user measurements	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	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 Outcome Measures

Name	Time	Method
Agreement between iCare® Home tonometry and GAT	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).

Trial Locations

Locations (1)

St Erik Eye Hospital; 🇸🇪 Stockholm, Sweden