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OpenTrials
Completed

NCT Number: NCT06450587

Intraocular Pressure Data Collection With Tonometers

The goal of this clinical trial is to collect a comprehensive dataset of intraocular pressure values for developing a measurement algorithm for the new hand-held rebound tonometer device. The measurement algorithm shall fulfill the requirements of ANSI Z80.10:2014 standard. The study population is adults (age ≥ 18 years).

The intraocular pressure of the participants will be measured with four different tonometers.

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

Optika Mesec d.o.o., Bled, Municipality of Bled, Slovenia

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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(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
  • Cataract Extraction within last 2 months in the study eye(s)

Treatment and study plan

iCare IC1000

Device

Measurement of Intraocular Pressure (IOP)

iCare ST500

Device

Measurement of Intraocular Pressure (IOP)

iCare IC200

Device

Measurement of Intraocular Pressure (IOP)

GAT

Device

Measurement of Intraocular Pressure (IOP)

Primary outcomes

  1. Primary Objective

    Time frame: Through study completion, an average of 4 months

    The primary objective of this study is to measure wide range of IOP values with the new tonometer and three comparator devices. The IOP value's unit of measure will be mmHg.

Sponsors and collaborators

Lead sponsor

Icare Finland Oy

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2024
Registry last updated
Apr 30, 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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