NCT05352906

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

April 25, 2022

Last Update Submit

April 25, 2022

Conditions

GlaucomaIntraocular PressureGlaucoma, Suspect

Keywords

GlaucomaSuspectTonometerAir-puff

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Accuracy of handheld tonometry

    Immediately after goldman applanation tonometry test for each eye.

Study Arms (3)

Contact goldman applanation tonometry

ACTIVE COMPARATOR

The standard contact tonometer

Diagnostic Test: Intraocular pressure

Handheld digital contact tonometer

ACTIVE COMPARATOR

A contact digital tonometer's pen.

Diagnostic Test: Intraocular pressure

Non-contact air-puff tonometer

ACTIVE COMPARATOR

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

Diagnostic Test: Intraocular pressure

Interventions

Intraocular pressureDIAGNOSTIC_TEST

Measurements of intraocular pressure in millimeter mercury (mmHg).

Contact goldman applanation tonometryHandheld digital contact tonometerNon-contact air-puff tonometer

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abdelshafy

Banhā, QA, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

Intraocular Pressure

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena

Study Officials

  • Ahmed A Abdelshafy, MD

    Benha University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Abdelshafy, MD

CONTACT

01222328766ahmad4lg@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology

Study Record Dates

First Submitted

April 25, 2022

First Posted

April 29, 2022

Study Start

April 20, 2022

Primary Completion

December 30, 2022

Study Completion

January 30, 2023

Last Updated

April 29, 2022

Record last verified: 2022-04

Locations

EG(1)