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.: PACTR201811613938575 Date of Approval: 27/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Q Value nomogram Versus Kera nomogram combined with ACXL
Official scientific title Keraring Implantation Using Keraring Nomogram Versus the Q Value Modified Nomogram of a Single Keraring Segment Implantation Combined with Accelerated Cross-Linking for Treatment of Keratoconus: a Comparative Study
Brief summary describing the background and objectives of the trial comparison between 2 types of nomograms in Keraring implantation combined with ACXL for treatment of keratoconus, the firstis the standard Keraring Nomogram while the seond is a new Q vlue-based new modified nomogram.
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 Treatment: Surgery
Anticipated trial start date 28/11/2018
Actual trial start date 01/12/2018
Anticipated date of last follow up 01/03/2019
Actual Last follow-up date 01/03/2019
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 104
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
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
Control Group KC Group once 3 months follow up 50 Placebo
Control Group Standard Nomogram once 6 months Kera rings implantation with femtosecond laser using Standard Keraring Nomogram combined with accelerated transepithelial CXL 52 Active-Treatment of Control Group
Experimental Group Q value based Nomogram once 6 months Kera rings implantation with femtosecond laser using Q value based Nomogram combined with accelerated transepithelial CXL 52
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age less than 40 years old Grade I and II Keratoconus No previous interventions Corneal opacity Previous Hydrops Age more than 40 years Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year 10 Year(s) 39 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 11/11/2018 Institutional Research Board in Faculty o 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 6 postoperative months
Secondary Outcome Corneal flattening and visual improvement 6 postoperative months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sohag University Hospital 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 Alexandria 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
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 Ahmed Tawfik Atawfika@gmail.com 00201000089352 Koliat Al Tob St, Shaibet an Nakareyah, Markaz El-Zakazik,
City Postal code Country Position/Affiliation
Zigzag 44519 Egypt Professor of ophthalmology in Zigzag 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 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 he results summary will be available as a PDF including topographic, visual and refractive outcomes 01/03/2019 01/07/2019
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/5762?p=advs
Changes to trial information