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iCare HOME2 Clinical Trial

Primary Purpose

Intraocular Pressure, Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iCare HOME2 vs iCare IC200
Sponsored by
Icare Finland Oy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intraocular Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • East West Eye Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

iCare HOME2 vs iCare IC200

Arm Description

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).

Outcomes

Primary Outcome Measures

Repeatability of IOP measurements
Repeatability of IOP measurements comparison of iCare HOME2 vs iCare IC200

Secondary Outcome Measures

Full Information

First Posted
December 16, 2021
Last Updated
December 17, 2021
Sponsor
Icare Finland Oy
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1. Study Identification

Unique Protocol Identification Number
NCT05162989
Brief Title
iCare HOME2 Clinical Trial
Official Title
iCare HOME2 Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 26, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icare Finland Oy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Pressure, Glaucoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Investigator cannot see both the test device and reference device measurement results.
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iCare HOME2 vs iCare IC200
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
iCare HOME2 vs iCare IC200
Intervention Description
Measurement of IOP with iCare HOME2 compared with iCare IC200.
Primary Outcome Measure Information:
Title
Repeatability of IOP measurements
Description
Repeatability of IOP measurements comparison of iCare HOME2 vs iCare IC200
Time Frame
Through study completion, an average of 1-2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle A Sato, MD
Organizational Affiliation
East West Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
East West Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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iCare HOME2 Clinical Trial

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