Clinical Study of the Topcon Pachymeter TRK-3 to Evaluate Agreement and Precision
Completed
- Conditions
- Corneal Thickness
- Interventions
- Device: SP-1P
- Registration Number
- NCT05283343
- Lead Sponsor
- Topcon Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adults 20 years old or older SP-1P -
- Primary Outcome Measures
Name Time Method Corneal thickness 1 day Corneal thickness
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Samoncho Clinic
🇯🇵Tokyo, Japan