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

• Sponsor: Topcon Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05283343
• Collaborator: (none)
• Enrollment: 30
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Thickness	Device: SP-1P

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Study of the Topcon Pachymeter TRK-3 to Evaluate Agreement and Precision
• Actual Study Start Date: Nov 27, 2021
• Actual Primary Completion Date: Nov 27, 2021
• Actual Study Completion Date: Nov 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Adults 20 years old or older	Device: SP-1P; A subject undergoes corneal thickness measurement with pachymeter.

Outcome Measures

Primary Outcome Measures

1. Corneal thickness [1 day]

   Corneal thickness

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samoncho Clinic	Tokyo		Japan

Sponsors and Collaborators

• Topcon Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Topcon Corporation
• ClinicalTrials.gov Identifier: NCT05283343
• Other Study ID Numbers: THQ-2021-05
• First Posted: Mar 16, 2022
• Last Update Posted: Jul 22, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Jul 22, 2022