TRK-3 Conformance to Standards for Tonometers

Completed

• Conditions: Glaucoma
• Interventions: Device: Tonometer

• Registration Number: NCT06247072
• Lead Sponsor: Topcon Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Study Start: 2024-02-02
• Study First Posted: 2024-02-07
• Status Verified: 2024-04
• Primary Completion: 2024-04-04
• Study Completion: 2024-04-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intermediate IOP	Tonometer	having intermediate IOP in one eye
high IOP	Tonometer	having high IOP in one eye
low IOP	Tonometer	having low IOP in one eye

Primary Outcome Measures

Name	Time	Method
IOP	1 day	pressure inside the eye

Trial Locations

Locations (2)

New View Optometric Center; 🇺🇸 La Mesa, California, United States

Illinois College of Optometry; 🇺🇸 Chicago, Illinois, United States