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OpenTrials
Completed

NCT Number: NCT06748092

Clinical Validation of iCare IC1000 Tonometer

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

Completed

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Key information

Conditions

Intraocular Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nova Scotia Health/Dalhousie University

Halifax, Nova Scotia, B3H 2Y9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iCare IC1000

Device

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

iCare IC200

Device

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

GAT

Device

Measurement of Intraocular Pressure (IOP) in sitting position

Perkins

Device

Measurement of Intraocular Pressure (IOP) in supine position

Primary outcomes

  1. Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers

    Time frame: Through study completion, an average of 6 months

    Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on the reference tonometer measurements. The iCare IC1000 Tonometer measurements shall be within +/-5.0 mmHg of the reference tonometer measurements in all groups.

Secondary outcomes

  1. Retrospective analysis of "Quick Measure" mode

    Time frame: Through study completion, an average of 6 months

    The secondary objective of this study is to do a retrospective analysis of "Quick Measure" mode. Instead of 6 shots that are taken in Default Measure, Quick Measure takes only 2 shots (or 3 shots if the difference between the first two shots is greater than 2 mmHg). The Quick Measure results are calculated retrospectively from the raw data of the Default Measure results. Quick Measure comparison to reference measurements is done similarly as with Default Measure.

Sponsors and collaborators

Lead sponsor

Icare Finland Oy

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2024
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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