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

Topcon

Status: Completed

Conditions: Corneal Thickness

Treatments: Device: SP-1P

Study type: Observational

Funder types: Industry

Identifiers

NCT05283343

THQ-2021-05

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Adults 20 years old or older

Treatment:

Device: SP-1P