GlaucomaNCT05352906
Accuracy of Handheld and Non-contact Tonometry
A study testing Intraocular pressure in people with Glaucoma and Intraocular Pressure, run by Benha University at 1 site in Egypt.
Trial summary
Monitoring the intraocular pressure (IOP) is one of the most important tests used in follow-up among glaucoma suspects and confirmed glaucomatous patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Intraocular Pressure, Glaucoma, Suspect
- What is being tested?
- Intraocular pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2022to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abdelshafy
Banhā, QA, 13511
Ahmed Abdelshafy, MD, 01222328766, ahmad4lg@gmail.com
Marwa Abdelshafy, MD, 01222328766, ahmad4lg@gmail.com
About this study
Official title: Accuracy of Handheld and Non-contact Tonometry in Clinical Practice
Monitoring the intraocular pressure (IOP) is one of the most important tests used in follow-up among glaucoma suspects and confirmed glaucomatous patients.
Read the 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.
- Conditions
- Glaucoma, Intraocular Pressure, Glaucoma, Suspect
- Being tested
- Intraocular pressure
- Keywords
- Glaucoma, Suspect, Tonometer, Air-puff
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular pressureDiagnostic test
Measurements of intraocular pressure in millimeter mercury (mmHg).
| Study group | Role | What they receive |
|---|---|---|
| Contact goldman applanation tonometry | Active comparator | The standard contact tonometer Receives: Diagnostic Test: Intraocular pressure |
| Handheld digital contact tonometer | Active comparator | A contact digital tonometer's pen. Receives: Diagnostic Test: Intraocular pressure |
| Non-contact air-puff tonometer | Active comparator | A non-contact tonometer based on air-puff and corneal hysteresis. Receives: Diagnostic Test: Intraocular pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of air-puff tonometry
Comparing IOP measurements in (mmHg) between standard goldman applanation tonometry and air-puff non-contact tonometry.
Measured: Immediately after goldman applanation tonometry test for each eye.
Secondary outcomes (1)
Accuracy of handheld tonometry
Comparing IOP measurements in (mmHg) between standard goldman applanation tonometry and handheld contact tonometry.
Measured: Immediately after goldman applanation tonometry test for each eye.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start20 Apr 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelshafy, Benha University
- Investigators
- Ahmed A Abdelshafy, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352906
- Sponsor's protocol ID
- RC-10-2022
- Status last verified
- Apr 2022
- First submitted
- 25 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Handheld and Non-contact Tonometry in Clinical Practice
- ClinicalTrials.gov ID
- NCT05352906
- Acronym / sponsor ID
- RC-10-2022
- Conditions
- Glaucoma, Intraocular Pressure, Glaucoma, Suspect
- Keywords
- Glaucoma, Suspect, Tonometer, Air-puff
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Contact goldman applanation tonometry | Active comparator | Diagnostic Test: Intraocular pressureThe standard contact tonometer |
| Handheld digital contact tonometer | Active comparator | Diagnostic Test: Intraocular pressureA contact digital tonometer's pen. |
| Non-contact air-puff tonometer | Active comparator | Diagnostic Test: Intraocular pressureA non-contact tonometer based on air-puff and corneal hysteresis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraocular pressureMeasurements of intraocular pressure in millimeter mercury (mmHg). | Diagnostic test | Contact goldman applanation tonometry, Handheld digital contact tonometer, Non-contact air-puff tonometer |
Primary outcome
Accuracy of air-puff tonometry
Time frame: 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.
1 secondary outcome
Accuracy of handheld tonometry
Time frame: Immediately after goldman applanation tonometry test for each eye.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed A Abdelshafy, MD principal investigator
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular pressure in people with Glaucoma and Intraocular Pressure, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abdelshafy, MD (01222328766, ahmad4lg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of air-puff tonometry (time frame: Immediately after goldman applanation tonometry test for each eye.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.