NCT05283343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

Same day

First QC Date

March 1, 2022

Last Update Submit

July 19, 2022

Conditions

Corneal Thickness

Outcome Measures

Primary Outcomes (1)

  • Corneal thickness

    Corneal thickness

    1 day

Study Arms (1)

Adults 20 years old or older

Device: SP-1P

Interventions

SP-1PDEVICE

A subject undergoes corneal thickness measurement with pachymeter.

Adults 20 years old or older

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects undergoing pachymetry measurement

You may qualify if:

  • Individuals who gave written informed consent to participate in the clinical trial by their free will.
  • Individuals who aged 20 years or older at the time of informed consent
  • Individuals who were deemed eligible for the study by the investigator for screening prior to enrollment.
  • 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.

You may not qualify if:

  • 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.
  • Individuals who have or are suspected of suffering from ocular or systemic infections.
  • Other persons who are judged by the investigator to be unfavorable candidates for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samoncho Clinic

Tokyo, Japan

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2022

First Posted

March 16, 2022

Study Start

November 27, 2021

Primary Completion

November 27, 2021

Study Completion

November 27, 2021

Last Updated

July 22, 2022

Record last verified: 2022-07

Locations

JP(1)