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OpenTrials
Completed

NCT Number: NCT07156630

Quick Measure Study for iCare ST500 and iCare IC200

The aim of this clinical study is to compare the agreement and precision of the intraocular pressure (IOP) results measured with the Quick Measure feature of iCare ST500 and iCare IC200 tonometers with results obtained with reference tonometers (Goldmann applanation tonometry and Tono-Vera tonometer). The data will be collected and evaluated in accordance with ISO 8612:2009 "Ophthalmic Instruments - Tonometers" (at least 120 eyes divided in three IOP groups with a minimum of 40 eyes per group, 95% of the paired differences between the reference tonometer and the test tonometer must fall within the tolerance of ±5 mmHg).

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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

NVision Clinical Research LLC

Torrance, California, 90505, United States

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 ST500

Device

Measurement of IOP

iCare IC200

Device

Measurement of IOP

GAT

Device

Measurement of IOP

Tonovera

Device

Measurement of IOP

Primary outcomes

  1. Demonstrate compliance with ISO 8612:2009-Ophthalmics-Ophthalmic Instruments-Tonometers

    Time frame: Through study completion, estimated 4 months

    Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on Goldmann Applanation Tonometer measurements. The iCare ST500 Tonometer and iCare IC200 Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups.

Sponsors and collaborators

Lead sponsor

Icare Finland Oy

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2025
Registry last updated
Dec 11, 2025

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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