- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05162989
iCare HOME2 Clinical Trial
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90013
- East West Eye Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Michelle A Sato, MD, East West Eye Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Glaucoma
-
Imperial College Healthcare NHS TrustIRIDEX CorporationNot yet recruitingGlaucoma | Glaucoma, Open-Angle | Glaucoma, Angle-Closure | Glaucoma, Neovascular | Glaucoma Eye | Glaucoma Secondary | Glaucoma Traumatic | Glaucoma Uveitic
-
Wills EyeIOP OphthalmicsTerminatedPrimary Open Angle Glaucoma | Neovascular Glaucoma | Uveitic Glaucoma | Pseudoexfoliation Glaucoma | Primary Angle Closure Glaucoma | Pigmentary Glaucoma | Traumatic GlaucomaUnited States
-
Centre hospitalier de l'Université de Montréal...CompletedGlaucoma | Glaucoma, Open-Angle | Glaucoma, Neovascular | Glaucoma Eye | Glaucoma and Ocular Hypertension | Glaucoma, Uncompensated | Glaucoma SecondaryCanada
-
Pro Top & Mediking Company LimitedCompletedOpen Angle Glaucoma | Neovascular Glaucoma | Angle Closure Glaucoma | Uveitis Glaucoma | Young Age Glaucoma | High Risk PatientEstonia
-
Sanoculis LtdCompletedPrimary Open Angle Glaucoma | Pigmentary Glaucoma | Pseudoexfoliative GlaucomaIsrael
-
Bausch & Lomb IncorporatedNicOx Inc.CompletedPrimary Open Angle Glaucoma | Ocular Hypertension | Pigmentary Glaucoma | Pseudoexfoliative GlaucomaUnited States
-
Sensimed AGCompletedPrimary Open Angle Glaucoma | Pigmentary Glaucoma | Pseudoexfoliative GlaucomaFrance
-
Ivantis, Inc.CompletedPrimary Open Angle Glaucoma | Pigmentary Glaucoma | Pseudoexfoliative GlaucomaUnited States
-
Wills EyeOptovueCompletedPrimary Open-angle Glaucoma | Normal Tension Glaucoma | Glaucoma; DrugsUnited States
-
iSTAR MedicalInternational Drug Development InstituteActive, not recruitingGlaucoma, Open-Angle Glaucoma EyeIndia, Panama
Clinical Trials on iCare HOME2 vs iCare IC200
-
The University of Texas Health Science Center,...Robert Cizik Eye ClinicCompletedIntraocular PressureUnited States
-
Comprehensive EyeCare of Central OhioIcare USACompletedEvaluation of Corneal Stability Post-applanationUnited States
-
Madonna Rehabilitation HospitalActive, not recruitingNeurological Injury | Neurological Diseases or ConditionsUnited States
-
NHS LothianUnknown
-
Luzerner KantonsspitalRecruitingIntraocular PressureSwitzerland
-
Universitaire Ziekenhuizen KU LeuvenUnknown
-
Indiana UniversityRecruitingTraumatic Brain Injury | Concussion, Severe | Concussion, Intermediate | Concussion With Brief Loss of Consciousness | Traumatic Brain Injury With Brief Loss of Consciousness | Traumatic Brain Injury With No Loss of Consciousness | Concussion With LOC 31 to 59 Minutes | Traumatic Brain Injury With... and other conditionsUnited States
-
Dartmouth-Hitchcock Medical CenterNational Institute of Mental Health (NIMH); Children's Hospital of Philadelphia and other collaboratorsRecruitingSuicidal Ideation | Mental Health Disorder | Emergency Psychiatric | Suicide AttemptUnited States
-
Carmel Medical CenterUnknownIntraocular Pressure | Retinal Nerve Fiber Bundle Deficiency