Status:
COMPLETED
Clinical Study of the Topcon Pachymeter TRK-3 to Evaluate Agreement and Precision
Lead Sponsor:
Topcon Corporation
Conditions:
Corneal Thickness
Eligibility:
All Genders
20+ years
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 27 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05283343
Start Date
November 27 2021
End Date
November 27 2021
Last Update
July 22 2022
Active Locations (1)
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1
Samoncho Clinic
Tokyo, Japan