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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201811672443486 Date of Approval: 21/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Egyptian Consensus on Keratoconus
Official scientific title Egyptian Consensus on Keratoconus Management: an EPK-Group Research Project
Brief summary describing the background and objectives of the trial this trial aims to unify the methods of diagnosis and treatment of Keratoconus in Egypt through 3 rounds of Delphi methods followed by face to face meeting of the Egyptian KC experts
Type of trial RCT
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 Diagnosis / Prognosis
Anticipated trial start date 22/11/2018
Actual trial start date 22/11/2018
Anticipated date of last follow up 01/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants) 500
Recruitment status 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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program 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 ICRS Once 3 months Kera rings implantation with femtosecond laser 100
Experimental Group ACXL Once 3 months Accelerated epithelium-off CXL, 9 minutes soaking time with riboflavin, 9 minutes UVA corneal irradiation pulsed mode. 100
Experimental Group SCXL Once 3 months Conventional epithelium-off CXL, 14 minutes soaking time with riboflavin, 30 minutes UVA corneal irradiation continuous mode. 100
Experimental Group CXLPLUS Once 3 months Kera rings implantation with femtosecond laser to be followed immediately by accelerated CXL, 10 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation pulsed mode. 100
Control Group kC Once 3 months follow-up 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age less than 30 years old Grade 1,2,3 and 4 Keratoconus No previous interventions Follow up for 3 years Corneal opacity Previous Hydrops Age more than 30 years Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 8 Year(s) 60 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
No 18/11/2018 Institutional Research Board in Faculty of Medicine Sohag University
Ethics Committee Address
Street address City Postal code Country
Sohag University Street Sohag City 82425 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Stability and prevention of KC progression 1,2, and 3 postoperative months
Secondary Outcome Corneal flattening and visual improvement 1,2, and 3 postoperative months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sohag University Hospitals Sohag University street Sohag City 82425 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohammed Iqba Sohag University Street Sohag City 82425 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohammed Iqbal Sohag University Street Sohag City 82425 Egypt Hospital
Secondary Sponsor Ahmed Elmassry Chamblion street, el azareeta, Alexandria Governorate Sohag City 21526 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohammed Iqbal Sohag University Street Sohag City 82425 Egypt
Ahmed Elmassry Chamblion street, el azareeta, Alexandria Governorate Alexandria 21526 Egypt
Ahmed Tawfik Koliat Al Tob St, Shaibet an Nakareyah, Markaz El-Zakazik, zagazig 44519 Egypt
Mervat Elgarib Suez Canal University Street Suez Canal City 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Iqbal dr_m_iqbal@yahoo.com 00201068559840 Sohag University Street
City Postal code Country Position/Affiliation
Sohag City 82425 Egypt Assistant Professor of Ophthalmology in Sohag University Hospital.
Role Name Email Phone Street address
Public Enquiries Mervat Elgharieb mershabrawy63@yahoo.com 00201005163965 Suez Canal University Street
City Postal code Country Position/Affiliation
Suez Canal City 41522 Egypt Assistant Professor of Ophthalmology in Suez Canal University Hospital.
Role Name Email Phone Street address
Scientific Enquiries Ahmed Elmassry ahmad.elmassry@gmail.com 00201222152435 Chamblion street, el azareeta, Alexandria Governorate
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of ophthalmology in Alexandria University Hospital.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be allowed for sharing Clinical Study Report,Statistical Analysis Plan,Study Protocol 12 months after end of study ophthalmologists are allowed for access of data. they should email the principal investigator via dr_m_iqbal@yahoo.com to get the permission after reviewing the qualifications and quality of request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes the results summary will be available as a PDF including topographic, visual and refractive outcomes 01/04/2019 01/08/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks http://staffsites.sohag-univ.edu.eg/stuff/advs/show/5643?p=advs
Changes to trial information