Accuracy of Handheld and Non-contact Tonometry

April 25, 2022 updated by: Ahmed Abdelshafy, Benha University

Accuracy of Handheld and Non-contact Tonometry in Clinical Practice

Monitoring the intraocular pressure (IOP) is one of the most important tests used in follow-up among glaucoma suspects and confirmed glaucomatous patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In tertiary hospitals, IOP screening is an important tool to confirm glaucomatous eyes. Inaccurate measurements may lead to missed diagnosis or false positive results that may affect patients' quality of life.

There are many devices produced to measure IOP, the commonest one is Goldman contact tonometry, the aim of this study is to compare the results of new developed tonometers to the standard applanation tonometer.

Study Type

Interventional

Enrollment (Anticipated)

300

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 Contact

Study Locations

  • Egypt
    • QA
      • Banhā, QA, Egypt, 13511
        • Recruiting
        • Ahmed Abdelshafy
        • Contact:
        • Contact:

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All subjects seeking regular check-up in glaucoma clinic at banha university hospital.
  • Glaucoma suspects and glaucomatous patients that visit glaucoma clinic for regular IOP measurements.

Exclusion Criteria:

  • Patients that will refuse to measure IOP again with other devices.
  • patients with previous corneal surgeries or scar that may alter the measurements of the tonometer s (as previous keratoplasty, trauma or opacities).

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Contact goldman applanation tonometry
The standard contact tonometer
Diagnostic test: Intraocular pressure
Measurements of intraocular pressure in millimeter mercury (mmHg).
Active Comparator: Handheld digital contact tonometer
A contact digital tonometer's pen.
Diagnostic test: Intraocular pressure
Measurements of intraocular pressure in millimeter mercury (mmHg).
Active Comparator: Non-contact air-puff tonometer
A non-contact tonometer based on air-puff and corneal hysteresis.
Diagnostic test: Intraocular pressure
Measurements of intraocular pressure in millimeter mercury (mmHg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of air-puff tonometry
Time Frame: Immediately after goldman applanation tonometry test for each eye.
Comparing IOP measurements in (mmHg) between standard goldman applanation tonometry and air-puff non-contact tonometry.
Immediately after goldman applanation tonometry test for each eye.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of handheld tonometry
Time Frame: Immediately after goldman applanation tonometry test for each eye.
Comparing IOP measurements in (mmHg) between standard goldman applanation tonometry and handheld contact tonometry.
Immediately after goldman applanation tonometry test for each eye.

Collaborators and Investigators

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

Sponsor

Benha University

Investigators

  • Principal Investigator: Ahmed A Abdelshafy, MD, Benha 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)

April 20, 2022

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

January 30, 2023

Study Registration Dates

First Submitted

April 25, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-10-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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