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

Corneal Thickness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05283343
• Other study ID #: THQ-2021-05
• Status: Completed
• Start date: November 27, 2021
• Est. completion date: November 27, 2021

Study information

• Verified date: July 2022
• Source: Topcon Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 27, 2021
• Est. primary completion date: November 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Thickness

Intervention

Device:
• SP-1P
A subject undergoes corneal thickness measurement with pachymeter.

Locations

Country	Name	City	State
Japan	Samoncho Clinic	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Topcon Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal thickness	Corneal thickness	1 day