Clinical Validation of iCare IC1000 Tonometer
1 other identifier
interventional
250
1 country
1
Brief Summary
Clinical validation of iCare IC1000 tonometer per ANSI Z80.10:2014 standard
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2024
CompletedFirst Posted
Study publicly available on registry
December 27, 2024
CompletedStudy Start
First participant enrolled
October 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedDecember 26, 2025
December 1, 2025
4 months
December 19, 2024
December 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers
Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on the reference tonometer measurements. The iCare IC1000 Tonometer measurements shall be within +/-5.0 mmHg of the reference tonometer measurements in all groups.
Through study completion, an average of 6 months
Secondary Outcomes (1)
Retrospective analysis of "Quick Measure" mode
Through study completion, an average of 6 months
Study Arms (1)
iCare IC1000 vs GAT, iCare IC200 and Perkins
EXPERIMENTALInterventions
Measurement of Intraocular Pressure (IOP) in sitting and supine position
Measurement of Intraocular Pressure (IOP) in sitting and supine position
Measurement of Intraocular Pressure (IOP) in sitting position
Measurement of Intraocular Pressure (IOP) in supine position
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
You may not qualify if:
- Subjects with only one functional eye
- Subjects having poor or eccentric fixation in the study eye
- High corneal astigmatism \>3D in the study eye
- Central corneal scarring
- History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye
- Microphthalmos
- Buphthalmos
- Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally
- Dry eyes (clinically significant)
- Lid squeezers - blepharospasm
- Nystagmus
- Keratoconus
- Any other corneal or conjunctival pathology or infection relevant to this study
- Central corneal thickness greater than 600 µm or less than 500 µm in the study eye
- Cataract Extraction within last 2 months in the study eye
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Icare Finland Oylead
Study Sites (1)
Nova Scotia Health/Dalhousie University
Halifax, Nova Scotia, B3H 2Y9, Canada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Investigator cannot see the measurement results.
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2024
First Posted
December 27, 2024
Study Start
October 21, 2025
Primary Completion
February 28, 2026
Study Completion
February 28, 2026
Last Updated
December 26, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share