RecruitingNot ApplicableNCT06748092

Clinical Validation of iCare IC1000 Tonometer


Sponsor

Icare Finland Oy

Enrollment

250 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Age ≥ 18 years

Exclusion Criteria15

  • 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

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Interventions

DEVICEiCare IC1000

Measurement of Intraocular Pressure (IOP) in sitting and supine position

DEVICEiCare IC200

Measurement of Intraocular Pressure (IOP) in sitting and supine position

DEVICEGAT

Measurement of Intraocular Pressure (IOP) in sitting position

DEVICEPerkins

Measurement of Intraocular Pressure (IOP) in supine position


Locations(1)

Nova Scotia Health/Dalhousie University

Halifax, Nova Scotia, Canada

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NCT06748092


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