Accuracy of Handheld and Non-contact Tonometry

NCT ID: NCT05352906

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-20

Study Completion Date

2023-01-30

Brief Summary

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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

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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.

Conditions

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Glaucoma Intraocular Pressure Glaucoma, Suspect

Keywords

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Glaucoma Suspect Tonometer Air-puff

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Contact goldman applanation tonometry

The standard contact tonometer

Group Type ACTIVE_COMPARATOR

Intraocular pressure

Intervention Type DIAGNOSTIC_TEST

Measurements of intraocular pressure in millimeter mercury (mmHg).

Handheld digital contact tonometer

A contact digital tonometer's pen.

Group Type ACTIVE_COMPARATOR

Intraocular pressure

Intervention Type DIAGNOSTIC_TEST

Measurements of intraocular pressure in millimeter mercury (mmHg).

Non-contact air-puff tonometer

A non-contact tonometer based on air-puff and corneal hysteresis.

Group Type ACTIVE_COMPARATOR

Intraocular pressure

Intervention Type DIAGNOSTIC_TEST

Measurements of intraocular pressure in millimeter mercury (mmHg).

Interventions

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Intraocular pressure

Measurements of intraocular pressure in millimeter mercury (mmHg).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdelshafy

Lecturer of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed A Abdelshafy, MD

Role: PRINCIPAL_INVESTIGATOR

Benha University

Locations

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Ahmed Abdelshafy

Banhā, QA, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Abdelshafy, MD

Role: CONTACT

Phone: 01222328766

Email: [email protected]

Facility Contacts

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Ahmed Abdelshafy, MD

Role: primary

Marwa Abdelshafy, MD

Role: backup

Other Identifiers

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RC-10-2022

Identifier Type: -

Identifier Source: org_study_id