iCare® Home vs Goldmann Applanation Tonometry

Sponsor

St. Erik Eye Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04911387

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Open Angle Glaucoma Ocular Hypertension Pseudo Exfoliation Syndrome	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 Design

Study Type:

Observational

Actual Enrollment :

61 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2020

Actual Primary Completion Date :

Oct 31, 2020

Actual Study Completion Date :

Oct 31, 2020

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.