TRK-3 Conformance to Standards for Tonometers

Topcon

Status: Completed

Conditions: Glaucoma

Treatments: Device: Tonometer

Study type: Observational

Funder types: Industry

Identifiers

NCT06247072

THQ-THINC-2023-02

Details and patient eligibility

About

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

Enrollment: 125 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

125 participants in 3 patient groups

low IOP

Description:

having low IOP in one eye

Treatment:

Device: Tonometer

intermediate IOP

Description:

having intermediate IOP in one eye

Treatment:

Device: Tonometer

high IOP

Description:

having high IOP in one eye

Treatment:

Device: Tonometer