Reliability and Reproducibility of the Eye Check Tonometer (EyeCheck)

November 4, 2022 updated by: Duke University

Reliability and Reproducibility of the Eye Check Tonometer Pressure Measurements as Measured by Patients Reliability and Reproducibility of the Eye Check Tonometer Pressure Measurements as Measured by Patients

To investigate whether the new applanation tonometer (EyeCheck monitor) can provide intraocular pressure (IOP) measurements comparable to those of traditional tonometers such as the Goldmann applanation tonometer and the Tonopen.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age of 18 years or older,
  • Any glaucoma patient or glaucoma suspect patient
  • Presents for an appointment wearing their own soft contact lens.

Exclusion Criteria:

  • Arthritis affecting the upper extremity in the patient or caregiver
  • Patient unwilling or assessed to be unable to comply with the study protocol
  • Any corneal abnormalities such as opacities, scars, Fuchs dystrophy, map dot fingerprint dystrophy, history of recurrent corneal abrasion, corneal surgery such as Lasik, PRK, DSAEK, transplant or implant
  • History of any ongoing ocular symptoms such as eye pain or redness or discharge
  • History of recent ocular surgery (done in the past 3 months)
  • History of a any filtering or tube surgery for glaucoma (to reduce risk of infection associated complications)
  • Recent eye infection (within the past 3 months)
  • History of diabetes for > 5 years duration
  • Monocular patient
  • Best corrected visual acuity< 20/70
  • Head or hand tremors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EyeCheck
EyeCheck pressures will be measured with contact lens in place
Device: EyeCheck
EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes.
Active Comparator: Traditional Tonometer (Goldmann and Tonopen)
Pressures will be measured with both Goldmann and Tonopen (both traditional tonometers to take the intraocular pressure (IOP) measurements of the eye).
Device: Traditional Tonometer (Goldmann and Tonopen)
Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure (IOP) measurements
Time Frame: Baseline
Compare EyeCheck intraocular pressure (IOP) measurements comparable to those of traditional tonometers (Goldmann and tonopen)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2021

Primary Completion (Actual)

December 2, 2021

Study Completion (Actual)

December 2, 2021

Study Registration Dates

First Submitted

November 17, 2020

First Submitted That Met QC Criteria

November 17, 2020

First Posted (Actual)

November 23, 2020

Study Record Updates

Last Update Posted (Actual)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00106897

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Currently, there is no plan to share data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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