NCT06250868

Brief Summary

To evaluate the performance of a new tonometer.

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 Feb 2024

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

First Submitted

Initial submission to the registry

February 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

6 days

First QC Date

February 1, 2024

Last Update Submit

February 29, 2024

Conditions

Normal

Outcome Measures

Primary Outcomes (1)

  • Cornea thickness

    Thickness of the cornea

    1 day

Study Arms (1)

Normal cornea

Device: Kerato-Refracto Tonometer

Interventions

Kerato-Refracto TonometerDEVICE

measures pressure inside the eye and thickness of the cornea.

Normal cornea

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who have healthy cornea

You may qualify if:

  • Provide voluntary written consent for participation in the study.
  • Age at least 22 years old at the time of informed consent.

You may not qualify if:

  • Ocular condition that may affect the ability to perform corneal measurement (e.g., corneal perforation, bullous keratopathy, nystagmus)
  • Have or is suspected to have an ocular infection in either eye.
  • Otherwise considered unsuitable for the study by the investigator
  • Unable to tolerate ophthalmic testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Topcon Healthcare Innovation Center

La Jolla, California, 92037, United States

Location

Study Design

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

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 9, 2024

Study Start

February 20, 2024

Primary Completion

February 26, 2024

Study Completion

February 26, 2024

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)