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CompletedNCT05162989Updated Dec 20, 2021

iCare HOME2 Clinical Trial

An interventional study of iCare HOME2 vs iCare IC200 in Intraocular Pressure and Glaucoma, sponsored by Icare Finland Oy. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-20.

Sponsored by Icare Finland Oy · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was Dec 2021, 4 years 9 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Intraocular Pressure
  • Glaucoma

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03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 47 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Icare Finland Oy is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    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).

    Device: iCare HOME2 vs iCare IC200

Interventions

  • DeviceiCare HOME2 vs iCare IC200

    Measurement of IOP with iCare HOME2 compared with iCare IC200.

06

What researchers measure

Primary outcomes

  1. Repeatability of IOP measurements

    Repeatability of IOP measurements comparison of iCare HOME2 vs iCare IC200

    Time frame: Through study completion, an average of 1-2 months

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Study locations

1 site
  • East West Eye Institute
    Los Angeles, California 90013, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05162989
Lead sponsor
Icare Finland Oy
Responsible party
Sponsor
First posted
Dec 20, 2021
Start date
Nov 26, 2021
Primary completion
Dec 15, 2021
Completion
Dec 15, 2021
Last update
Dec 20, 2021

Study contacts

Michelle A Sato, MD
principal investigator · East West Eye Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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