Intraocular Pressure Data Collection With Tonometers

Not Applicable

Completed

• Conditions: Intraocular Pressure
• Interventions: Device: iCare IC1000; Device: iCare ST500; Device: iCare IC200; Device: GAT

• Registration Number: NCT06450587
• Lead Sponsor: Icare Finland Oy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-29
• Study First Submitted: 2024-05-31
• Study First Submitted QC: 2024-06-07
• Study First Posted: 2024-06-10
• Primary Completion: 2025-02-07
• Study Completion: 2025-02-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• Age ≥ 18 years

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Measurement of IOP Values	iCare ST500	Measurement of IOP pressure with four different tonometers.
Measurement of IOP Values	iCare IC200	Measurement of IOP pressure with four different tonometers.
Measurement of IOP Values	GAT	Measurement of IOP pressure with four different tonometers.
Measurement of IOP Values	iCare IC1000	Measurement of IOP pressure with four different tonometers.

Primary Outcome Measures

Name	Time	Method
Primary Objective	Through study completion, an average of 4 months	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.

Trial Locations

Locations (2)

Vid d.o.o.; 🇸🇮 Kromberk, Nova Gorica, Slovenia

Optika Mesec d.o.o.; 🇸🇮 Bled, Slovenia