NCT05162989

iCare HOME2 Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Icare Finland Oy · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinical study is to provide information about the variability of the intraocular pressure (IOP) self-measurements with the iCare HOME2 tonometer in comparison to the variability of the IOP measurements with the reference tonometer (iCare IC200), over a wide range of IOP values.

Detailed description

The clinical study is planned to estimate the variability of the IOP measurement of iCare HOME2 and IC200. In the study, the subjects will learn to operate the iCare HOME2 tonometer independently by using the labeling materials provided to them. Once they learn to operate the tonometer, subjects will take three self-measurements on the selected eye both in sitting and supine position. The variability of the measurement results taken with iCare HOME2 will be compared to the variability of the measurement results taken with iCare IC200 by using the recorded results from the study subjects.

Conditions

• Intraocular Pressure
• Glaucoma

Interventions

Type	Name	Description
DEVICE	iCare HOME2 vs iCare IC200	Measurement of IOP with iCare HOME2 compared with iCare IC200.

Timeline

• Start date: 2021-11-26
• Primary completion: 2021-12-15
• Completion: 2021-12-15
• First posted: 2021-12-20
• Last updated: 2021-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study