Intraocular Pressure Data Collection With Tonometers
1 other identifier
interventional
151
1 country
2
Brief Summary
The goal of this clinical trial is to collect a comprehensive dataset of intraocular pressure values for developing a measurement algorithm for the new hand-held rebound tonometer device. The measurement algorithm shall fulfill the requirements of ANSI Z80.10:2014 standard. The study population is adults (age ≥ 18 years). The intraocular pressure of the participants will be measured with four different tonometers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2024
Shorter than P25 for not_applicable
2 active sites
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
Study Start
First participant enrolled
May 29, 2024
CompletedFirst Submitted
Initial submission to the registry
May 31, 2024
CompletedFirst Posted
Study publicly available on registry
June 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2025
CompletedApril 30, 2025
April 1, 2025
8 months
May 31, 2024
April 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Objective
The primary objective of this study is to measure wide range of IOP values with the new tonometer and three comparator devices. The IOP value's unit of measure will be mmHg.
Through study completion, an average of 4 months
Study Arms (1)
Measurement of IOP Values
EXPERIMENTALMeasurement of IOP pressure with four different tonometers.
Interventions
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(s)
- High corneal astigmatism \>3D in the study eye(s)
- Central corneal scarring
- History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s)
- 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
- Cataract Extraction within last 2 months in the study eye(s)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Icare Finland Oylead
Study Sites (2)
Vid d.o.o.
Kromberk, Nova Gorica, 5000, Slovenia
Optika Mesec d.o.o.
Bled, Občina Bled, 4260, Slovenia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2024
First Posted
June 10, 2024
Study Start
May 29, 2024
Primary Completion
February 7, 2025
Study Completion
February 7, 2025
Last Updated
April 30, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share