Corneal Thickness
Conditions
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.
Interventions
DEVICESP-1P
A subject undergoes corneal thickness measurement with pachymeter.
Sponsors
Topcon Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Individuals who gave written informed consent to participate in the clinical trial by their free will. 2. Individuals who aged 20 years or older at the time of informed consent 3. Individuals who were deemed eligible for the study by the investigator for screening prior to enrollment. 4. 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
1. 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. 2. Individuals who have or are suspected of suffering from ocular or systemic infections. 3. Other persons who are judged by the investigator to be unfavorable candidates for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal thickness | 1 day | Corneal thickness |
Countries
Japan
Outcome results
None listed