TRK-3 Conformance to Standards for Tonometers

To collect measurements of a new tonometer and show conformance to standards for tonometers.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: Tonometer

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

• Study Contact: Name: Mayra Tafreshi, MBA; Phone Number: 858-247-9117; Email: mtafreshi@topcon.com

Study Locations

• United States
  • California
    • La Mesa, California, United States, 91942
      • New View Optometric Center
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Illinois College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Eyes with different range of IOP

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Have only one functional eye
2. Have difficulty in ocular fixation or eccentric fixation in either eye
3. Have corneal scar or have a history of corneal surgery such as corneal laser surgery (cataract surgery is acceptable)
4. Have microphthalmia
5. Have buphthalmos
6. Wear contact lens (have used soft contact lenses within the last 3 months and/or hard contact lenses within the last 6 months)
7. Have dry eyes and taking prescription medication or using artificial tears daily
8. Have blepharospasm
9. Have nystagmus
10. Have keratoconus
11. Have corneal or conjunctival lesions or infections
12. Have a central corneal thickness of <500μm or >600μm
13. Have corneal astigmatism >3D
14. Have known allergy to ophthalmic anesthetics
15. Have known allergy to sodium fluorescein

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
low IOP; having low IOP in one eye	Device: Tonometer; measures IOP
intermediate IOP; having intermediate IOP in one eye	Device: Tonometer; measures IOP
high IOP; having high IOP in one eye	Device: Tonometer; measures IOP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP	pressure inside the eye	1 day

Collaborators and Investigators

• Sponsor: Topcon Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Actual): April 4, 2024
• Study Completion (Actual): April 4, 2024

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: THQ-THINC-2023-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No