Clinical Study of the Topcon Tonometer TRK-3

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

139 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-11

Study Completion Date

2022-01-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study will assess the TRK-3 for conformity to ISO 8612:2009, JIS T7312:2015, and ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification \[510(k)\] Submissions, and the applicable Supplemental Information Sheet.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Study of the Topcon Pachymeter TRK-3 to Evaluate Agreement and Precision

NCT05283343

Corneal Thickness

COMPLETED

Agreement and Precision Study

NCT06733428

Eye Abnormalities Normal Eyes

COMPLETED

Quick Measure Study for iCare ST500 and iCare IC200

NCT07156630

Intraocular Pressure

COMPLETED NA

EVALUATION of CATS TONOMETER PRISM in LASIK SUBJECTS

NCT06266351

Glaucoma Ocular Hypertension Normal Tension Glaucoma

COMPLETED

Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens

NCT04542525

Aphakia Corneal Astigmatism

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intraocular Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tonometer

A subject undergoes intraocular pressure measurement with tonometer

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Be 18 years of age or older at the time of informed consent
2. Irrespective of sex
3. Irrespective of race or ethnicity
4. Be willing and able to provide written informed consent by subject or legally designated representative prior to any study procedures

Exclusion Criteria

1. Have only one functional eye
2. Have one eye with poor or eccentric fixation
3. Have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye
4. Have microphthalmos in either eye
5. Have buphthalmos in either eye
6. Be a contact lens wearer (persons wearing soft contact lenses within the past 3 months and/or hard contact lenses within the past 6 months)
7. Have dry eyes (persons who have been diagnosed by a physician and are currently using prescription drugs or routinely using artificial tears)
8. Uncontrollably blink, squint, wink, twitch or squeeze eye(s) - blepharospasm
9. Have nystagmus in either eye
10. Have keratoconus in either eye
11. Have any other corneal or conjunctival pathology or infection in either eye
12. Have central corneal thickness is less than 500μm or more than 600μm
13. Be allergic to eye drop anesthetics
14. Be allergic to sodium fluorescein

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes