iCare® Home vs Goldmann Applanation Tonometry

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04911387
• Other study ID #: iCare Home vs GAT
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: May 2021
• Source: St. Erik Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Exfoliation Syndrome
• Glaucoma
• Glaucoma, Open-Angle
• Ocular Hypertension
• Open Angle Glaucoma
• Pseudo Exfoliation Syndrome

Intervention

Device:
• Intraocular pressure measurments
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.

Locations

Country	Name	City	State
Sweden	St Erik Eye Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
St. Erik Eye Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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