Clinical trial NCT04911387: iCare® Home vs Goldmann Applanation Tonometry
Official title: iCare® Home vs Goldmann Applanation Tonometry: Agreement of the Methods and Comparison of Inter-observer Variation at a Tertiary Eye Centre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Open Angle Glaucoma
Ocular Hypertension
Pseudo Exfoliation Syndrome
Keywords: intraocular pressure
GAT
rebound tonometry
self-tonometry
iCare® Home
Lead sponsor: St. Erik Eye Hospital
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between iCare® Home inter-user measurements
timeFrame: 12 months
measure: Correlation between GAT measurements made by different healthcare personnel
timeFrame: 12 months
Secondary outcomes:
measure: Agreement between iCare® Home tonometry and GAT
timeFrame: 12 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: St Erik Eye Hospital
Study officials:
affiliation: St. Erik Eye Hospital
name: Enping Chen, MD Ph D
role: PRINCIPAL_INVESTIGATOR
References: