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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-27

Study Completion Date

2021-11-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Corneal Thickness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults 20 years old or older

SP-1P

Intervention Type DEVICE

A subject undergoes corneal thickness measurement with pachymeter.

Interventions

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SP-1P

A subject undergoes corneal thickness measurement with pachymeter.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes