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NCT06247072 Clinical Trial

TRK-3 Conformance to Standards for Tonometers

Glaucoma Clinical Trial

Official title:
TRK-3 Conformance to Standards for Tonometers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06247072
Other study ID # THQ-THINC-2023-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2, 2024
Est. completion date April 4, 2024

Study information
Verified date April 2024
Source Topcon Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date April 4, 2024
Est. primary completion date April 4, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Tonometer
measures IOP

Locations
Country Name City State
United States Illinois College of Optometry Chicago Illinois
United States New View Optometric Center La Mesa California

Sponsors (1)
Lead Sponsor Collaborator
Topcon Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary IOP pressure inside the eye 1 day
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