Clinical Validation of iCare IC1000 Tonometer

Icare

Status: Not yet enrolling

Conditions: Intraocular Pressure

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06748092

TA032-135

Details and patient eligibility

About

Clinical validation of iCare IC1000 tonometer per ANSI Z80.10:2014 standard

Enrollment: 250 estimated 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
• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

iCare IC1000 vs GAT, iCare IC200 and Perkins

Experimental group

Treatment:

Device: iCare IC200

Device: Perkins

Device: iCare IC1000

Device: GAT