Intraocular Pressure Data Collection With Tonometers

Icare

Status: Completed

Conditions: Intraocular Pressure

Treatments: Device: iCare ST500; Device: GAT; Device: iCare IC200; Device: iCare IC1000

Study type: Interventional

Funder types: Industry

Identifiers

NCT06450587

TA032-082

Details and patient eligibility

About

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.

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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151 participants in 1 patient group

Measurement of IOP Values

Experimental group

Description:

Measurement of IOP pressure with four different tonometers.

Treatment:

Device: iCare IC1000

Device: iCare IC200

Device: GAT

Device: iCare ST500