Accuracy of Handheld and Non-contact Tonometry

Glaucoma Clinical Trial

Official title:

Accuracy of Handheld and Non-contact Tonometry in Clinical Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05352906
• Other study ID #: RC-10-2022
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: April 2022
• Source: Benha University
• Contact: Ahmed Abdelshafy, MD
• Phone: 01222328766
• Email: ahmad4lg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Suspect
• Intraocular Pressure
• Ocular Hypertension

Intervention

Diagnostic Test:
• Intraocular pressure
Measurements of intraocular pressure in millimeter mercury (mmHg).

Locations

Country	Name	City	State
Egypt	Ahmed Abdelshafy	Banha	QA

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.