Accuracy of Handheld and Non-contact Tonometry

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: Glaucoma; Intraocular Pressure; Glaucoma, Suspect
• Intervention / Treatment: Diagnostic test: Intraocular pressure

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

• Study Contact: Name: Ahmed Abdelshafy, MD; Phone Number: 01222328766; Email: ahmad4lg@gmail.com

Study Locations

• Egypt
  • QA
    • Banhā, QA, Egypt, 13511
      • Recruiting
      • Ahmed Abdelshafy
      • Contact: Ahmed Abdelshafy, MD; Phone Number: 01222328766; Email: ahmad4lg@gmail.com
      • Contact: Marwa Abdelshafy, MD; Phone Number: 01222328766; Email: ahmad4lg@gmail.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	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	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

• Sponsor: Benha University
• Investigators: Principal Investigator: Ahmed A Abdelshafy, MD, Benha University

Study record dates

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: Glaucoma; Suspect; Tonometer; Air-puff
• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Ocular Hypertension
• 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