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Clinical Study for TONOREF III Tested to ANSI Z80.10-2014 | Clinical Trials | Clareo Health

COMPLETED

Clinical Study for TONOREF III Tested to ANSI Z80.10-2014

Clinical Pilot Study to Provide Research Data for TONOREF III Tested to ANSI Z80.10-2014

NCT07152808•Nidek Co. LTD.

Summary

The primary objective of this clinical study was to show that tonometry values for TONOREF III, as the representative device of the NIDEK tonometer series, were comparable to the predicate device. The secondary objective was to demonstrate that the test device was as safe as the predicate device.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Each subject had to have:
•1. been at least 22 years of age of either sex and any race or ethnicity;
•2. been willing and able to provide written informed consent prior to any study procedures being performed;
•3. been willing and able to follow all instructions and attend all study visits;
•4. corneal astigmatism of ≤3D and corneal thickness of 500-600 μm in at least one eye.

Exclusion Criteria

•Each subject had to not to :
•1. have only one functional eye;
•2. have poor or eccentric fixation in the study eye;
•3. have corneal scarring or have had corneal surgery, including corneal laser surgery in the study eye
•4. have microphthalmos in the study eye;
•5. have buphthalmos in the study eye;
•6. be a contact lens wearer in the study eye;
•7. have dry eyes;
•8. be a lid squeezer - blepharospasm;
•9. have nystagmus in the study eye;
+5 more criteria

Key Dates

Start Date

September 2, 2022

Primary Completion Date

June 19, 2023

Completion Date

June 19, 2023

Last Updated

February 4, 2026

Enrollment

ACTUAL participants

Conditions

Intraocular Pressure

Interventions

NIDEK TONOREF III

DEVICE

Haag-Streit Goldmann Manual Tonometer

DEVICE

24-hour Wear Performance and Safety Study of Smartlens miLens Contact Lens for IOP Monitoring

NCT06689696

GlaucomaGLAUCOMA 1, OPEN ANGLE, D (Disorder)+9 more

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COMPLETEDNA

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NCT07424417

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Study for TONOREF III Tested to ANSI Z80.10-2014

Inclusion Criteria

Exclusion Criteria

24-hour Wear Performance and Safety Study of Smartlens miLens Contact Lens for IOP Monitoring

Upper Extremity Position and Intraocular Pressure During Spinal Anesthesia

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