Back to resultsAccuracy of Handheld and Non-contact Tonometry
Primary Purpose
Glaucoma, Intraocular Pressure, Glaucoma, Suspect
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Intraocular pressure
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma focused on measuring Glaucoma, Suspect, Tonometer, Air-puff
Eligibility Criteria
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).
Sites / Locations
- Ahmed AbdelshafyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Contact goldman applanation tonometry
Handheld digital contact tonometer
Non-contact air-puff tonometer
Arm Description
The standard contact tonometer
A contact digital tonometer's pen.
A non-contact tonometer based on air-puff and corneal hysteresis.
Outcomes
Primary Outcome Measures
Accuracy of air-puff tonometry
Comparing IOP measurements in (mmHg) between standard goldman applanation tonometry and air-puff non-contact tonometry.
Secondary Outcome Measures
Accuracy of handheld tonometry
Comparing IOP measurements in (mmHg) between standard goldman applanation tonometry and handheld contact tonometry.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05352906
Brief Title
Accuracy of Handheld and Non-contact Tonometry
Official Title
Accuracy of Handheld and Non-contact Tonometry in Clinical Practice
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Intraocular Pressure, Glaucoma, Suspect
Keywords
Glaucoma, Suspect, Tonometer, Air-puff
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Contact goldman applanation tonometry
Arm Type
Active Comparator
Arm Description
The standard contact tonometer
Arm Title
Handheld digital contact tonometer
Arm Type
Active Comparator
Arm Description
A contact digital tonometer's pen.
Arm Title
Non-contact air-puff tonometer
Arm Type
Active Comparator
Arm Description
A non-contact tonometer based on air-puff and corneal hysteresis.
Intervention Type
Diagnostic Test
Intervention Name(s)
Intraocular pressure
Intervention Description
Measurements of intraocular pressure in millimeter mercury (mmHg).
Primary Outcome Measure Information:
Title
Accuracy of air-puff tonometry
Description
Comparing IOP measurements in (mmHg) between standard goldman applanation tonometry and air-puff non-contact tonometry.
Time Frame
Immediately after goldman applanation tonometry test for each eye.
Secondary Outcome Measure Information:
Title
Accuracy of handheld tonometry
Description
Comparing IOP measurements in (mmHg) between standard goldman applanation tonometry and handheld contact tonometry.
Time Frame
Immediately after goldman applanation tonometry test for each eye.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdelshafy, MD
Phone
01222328766
Email
ahmad4lg@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A Abdelshafy, MD
Organizational Affiliation
Benha University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed Abdelshafy
City
Banhā
State/Province
QA
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelshafy, MD
Phone
01222328766
Email
ahmad4lg@gmail.com
First Name & Middle Initial & Last Name & Degree
Marwa Abdelshafy, MD
Phone
01222328766
Email
ahmad4lg@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Accuracy of Handheld and Non-contact Tonometry
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