Accuracy of Handheld and Non-contact Tonometry

Sponsor

Benha University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05352906

Collaborator

(none)

300

Enrollment

Location

Arms

9.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Intraocular Pressure Glaucoma, Suspect	Diagnostic Test: Intraocular pressure	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Accuracy of Handheld and Non-contact Tonometry in Clinical Practice

Actual Study Start Date :

Apr 20, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Jan 30, 2023

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Abdelshafy	Banhā	QA	Egypt	13511

Sponsors and Collaborators

Benha University

Investigators

Principal Investigator: Ahmed A Abdelshafy, MD, Benha University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Abdelshafy, Lecturer of Ophthalmology, Benha University

ClinicalTrials.gov Identifier:

NCT05352906

Other Study ID Numbers:

RC-10-2022

First Posted:

Apr 29, 2022

Last Update Posted:

Apr 29, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Ahmed Abdelshafy, Lecturer of Ophthalmology, Benha University

Additional relevant MeSH terms:

Glaucoma

Ocular Hypertension

Study Results

No Results Posted as of Apr 29, 2022