TRK-3 Conformance to Standards for Tonometers

NCT ID: NCT06247072

Last Updated: 2024-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-02

Study Completion Date

2024-04-04

Brief Summary

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

Detailed Description

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Conditions

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Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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low IOP

having low IOP in one eye

Tonometer

Intervention Type DEVICE

measures IOP

intermediate IOP

having intermediate IOP in one eye

Tonometer

Intervention Type DEVICE

measures IOP

high IOP

having high IOP in one eye

Tonometer

Intervention Type DEVICE

measures IOP

Interventions

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Tonometer

measures IOP

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Topcon Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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New View Optometric Center

La Mesa, California, United States

Site Status

Illinois College of Optometry

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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THQ-THINC-2023-02

Identifier Type: -

Identifier Source: org_study_id

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