Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202407522723427 Date of Registration: 29/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation the accuracy of Air Puff Tonometer Compared to Goldmann and Schiotz
Official scientific title Evaluation the accuracy of Air Puff Tonometer Compared to Goldmann and Schiotz
Brief summary describing the background and objectives of the trial To evaluate accuracy of air puff tonometer in comparison to Goldmann applanation and Schiotz tonometers. Previous studies proved that GAT is the most accurat device to measure IOP, but due to the need of quick and non contact devices as air puff tonometry –espicially with the current wave of covid 19- it’s become essential to depend on the air puff tonometry completely. This study will help in providing a critical data compairing IOP measured by the three devices, which will let us know if the over reading measured by air puff can be neglected or it would affects our judgment dramatically.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 15/07/2024
Actual trial start date
Anticipated date of last follow up 30/07/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Measuring intraocular pressure Same clinic visit 1. Central corneal thickness is measured by pachymetry device (Compact Touch) followed by IOP testing. 2. The IOP was measured by GAT, Schiotz tonometer and air puff tonometry (Topcon CT-1) starting with the air puff, then GAT and finally Schiotz tonometer. 3. There was about 2 minutes interval between different assessments. 4. Calibration of the tonometers has been performed after every measurement. 5. All assessments were done nearly at the same time of the day to avoid diurnal variations. 6. Starting with air puff tonometry by positioning patient’s head with his/her eyes widely opened and fixed then making three readings. 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
History of primary open angle glaucoma. 1. History of secondary open angle glaucoma such as steroid-induced glaucoma, pigmentary glaucoma and pseudoexfoliation glaucoma. 2. Corneal disorders such as keratitis, corneal ulcer, exposure keratopathy, corneal dystrophy and corneal degeneration. 3. Use of contact lens within 24 hours. 4. Silicon-filled eyes. Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/04/2023 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
23 December street Port Said 8541302 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Measuring IOP of 200 patient by GAT, Schiotz and air-puff tonometers. During the patient visit to clinic as a routine examination.
Secondary Outcome After completing the measurement of IOP for 200 patient and comparing the IOP for the 3 devices in glaucoma patients and normal healthy individuals. After completing measuring IOP for 200 patients.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Specialized Ophthalmology hospital 23 July street Port Said Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Port Said specialized Ophthalmology hospital 23 July street Port Said Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Port Said university 23 December street Port Said Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ehab Ghoneim ehabghoneim@hotmail.com +201223639848 Mohamed Ali street
City Postal code Country Position/Affiliation
Port Said Egypt Supervisor
Role Name Email Phone Street address
Public Enquiries Gehad Gamil gogololojodo@gmail.com +201068498281 Mohamed Ghandar street
City Postal code Country Position/Affiliation
Port Said Egypt Data analyser
Role Name Email Phone Street address
Scientific Enquiries Amr Gab Alla amrophth@hotmail.com +201222836261 Al Ishrin street
City Postal code Country Position/Affiliation
Ismailia Egypt Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification including Study Protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report, Analytic code. Immediately following publication for anyone who wishes to access the data for any purpose . It will be available after publication at opthalmology journal and university site. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 6 months Objectives Methodology Results
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information