iCare HOME2 Clinical Trial
December 17, 2021 updated by: Icare Finland Oy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90013
- East West Eye Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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).
|
Measurement of IOP with iCare HOME2 compared with iCare IC200.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Repeatability of IOP measurements
Time Frame: Through study completion, an average of 1-2 months
|
Repeatability of IOP measurements comparison of iCare HOME2 vs iCare IC200
|
Through study completion, an average of 1-2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michelle A Sato, MD, East West Eye Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 26, 2021
Primary Completion (Actual)
December 15, 2021
Study Completion (Actual)
December 15, 2021
Study Registration Dates
First Submitted
December 16, 2021
First Submitted That Met QC Criteria
December 17, 2021
First Posted (Actual)
December 20, 2021
Study Record Updates
Last Update Posted (Actual)
December 20, 2021
Last Update Submitted That Met QC Criteria
December 17, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TA023-207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.