Skip to main content
OpenTrials
Completed

NCT Number: NCT05283343

Clinical Study of the Topcon Pachymeter TRK-3 to Evaluate Agreement and Precision

Agreement and Precision of corneal thickness measurement (pachymetry) function of the test device TRK-3 and the predicate device SP-1P will be evaluated in volunteers, and safety will be evaluated.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Corneal Thickness

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samoncho Clinic

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Individuals who gave written informed consent to participate in the clinical trial by their free will.
  • Individuals who aged 20 years or older at the time of informed consent
  • Individuals who were deemed eligible for the study by the investigator for screening prior to enrollment.
  • Subjects who are able to comply with compliance items during participation in the clinical trial, undergo medical examination and examination specified in the protocol, and report subjective symptoms, etc.

Exclusion criteria

  • Individuals with ocular diseases that may affect corneal thickness measurement (blindness, corneal perforation, bullous keratopathy, nystagmus, etc.) or who have a history of ocular diseases and are considered by the investigator to be ineligible for participation in the study.
  • Individuals who have or are suspected of suffering from ocular or systemic infections.
  • Other persons who are judged by the investigator to be unfavorable candidates for the study.

Treatment and study plan

SP-1P

Device

A subject undergoes corneal thickness measurement with pachymeter.

Primary outcomes

  1. Corneal thickness

    Time frame: 1 day

    Corneal thickness

Sponsors and collaborators

Lead sponsor

Topcon Corporation

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2022
Registry last updated
Jul 22, 2022

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.