iCare HOME2 Clinical Trial

Not Applicable

Completed

• Conditions: Glaucoma; Intraocular Pressure
• Interventions: Device: iCare HOME2 vs iCare IC200

• Registration Number: NCT05162989
• Lead Sponsor: Icare Finland Oy

Brief 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.

Study Timeline

• Study Start: 2021-11-26
• Status Verified: 2021-12
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-15
• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2021-12-17
• Last Update Submitted: 2021-12-17
• Study First Posted: 2021-12-20
• Last Update Posted: 2021-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Glaucoma patients having confirmed optic nerve damage with visual field defects consistent with the glaucomatous optic neuropathy or
• Glaucoma-suspects being followed because of elevated IOP, and/or because of other risk factors for developing glaucoma or optic nerve damage.

Exclusion Criteria

• Active ocular infection (e.g., pink eye or infectious conjunctivitis)
• Recent trauma to the eye including corneal laceration or corneal/scleral perforation
• Disabling arthritis or difficulty handling the tonometer
• Severe difficulty in opening the eyes including abnormal contractions or twitches of the eyelid (blepharospasm)
• Involuntary, rapid, and repetitive eye movements (nystagmus)
• Low uncorrected near visual acuity of 20/200 or below
• Significant glaucomatous central field loss
• Only one functional eye
• Poor or off-center visual fixation
• Poor hearing and/or communicates using sign language
• Keratoconus (or other corneal disorder)
• Congenitally small eye (microphthalmos)
• Enlarged eyeball from the childhood glaucoma (buphthalmos)
• Previous experience using or interacting with the HOME tonometer during usability tests or clinical trials
• Any affiliation with Icare and its employees
• High corneal astigmatism (>3d)
• History of prior invasive corneal surgery including corneal laser surgery less than six months ago (e.g., LASIK, LASEK, Smile)
• Corneal scarring
• Very thick or very thin corneas (central corneal thickness greater than 600 μm or less than 500 μm)
• Cataract extraction within the last 2 months
• Wearing contact lenses during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iCare HOME2 vs iCare IC200	iCare HOME2 vs iCare IC200	Measurement of intraocular pressure (IOP) with iCare IC200 reference tonometer compared to iCare HOME2 test tonometer. Measurement will be performed to categorize each subject as having Low IOP (7 to 16 mmHg), Medium IOP (\>16 to \<23 mmHg), or High IOP (≥23 mmHg).

Primary Outcome Measures

Name	Time	Method
Repeatability of IOP measurements	Through study completion, an average of 1-2 months	Repeatability of IOP measurements comparison of iCare HOME2 vs iCare IC200

Trial Locations

Locations (1)

East West Eye Institute; 🇺🇸 Los Angeles, California, United States