Accuracy of Handheld and Non-contact Tonometry

Not Applicable

• Conditions: Glaucoma, Suspect; Glaucoma; Intraocular Pressure
• Interventions: Diagnostic Test: Intraocular pressure

• Registration Number: NCT05352906
• Lead Sponsor: Benha University

Brief Summary

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

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 Timeline

• Status Verified: 2022-04
• Study Start: 2022-04-20
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-25
• Last Update Submitted: 2022-04-25
• Study First Posted: 2022-04-29
• Last Update Posted: 2022-04-29
• Primary Completion: 2022-12-30
• Study Completion: 2023-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contact goldman applanation tonometry	Intraocular pressure	The standard contact tonometer
Handheld digital contact tonometer	Intraocular pressure	A contact digital tonometer's pen.
Non-contact air-puff tonometer	Intraocular pressure	A non-contact tonometer based on air-puff and corneal hysteresis.

Primary Outcome Measures

Name	Time	Method
Accuracy of air-puff tonometry	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.

Secondary Outcome Measures

Name	Time	Method
Accuracy of handheld tonometry	Immediately after goldman applanation tonometry test for each eye.	Comparing IOP measurements in (mmHg) between standard goldman applanation tonometry and handheld contact tonometry.

Trial Locations

Locations (1)

Ahmed Abdelshafy; 🇪🇬 Banhā, QA, Egypt