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OpenTrials
Completed

NCT Number: NCT05742009

iCare ST500 Clinical Trial

Clinical validation of iCare ST500 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

  • Patients at least 18 years old

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
  • Central corneal thickness greater than 600 μm or less than 500 μm in the study eye(s)
  • Cataract Extraction within last 2 months in the study eye(s)

Treatment and study plan

iCare ST500

Device

Measurement of Intraocular Pressure (IOP)

GAT

Device

Measurement of Intraocular Pressure (IOP)

iCare IC200

Device

Measurement of Intraocular Pressure (IOP)

Primary outcomes

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

    Time frame: Through study completion, an average of 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 measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups.

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Icare Finland Oy

Industry

Registry information

Official study title

Clinical Validation of a Slit Lamp Mounted Rebound Tonometer

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2023
Registry last updated
Nov 30, 2023

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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