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.: PACTR201902485435341 Date of Approval: 12/02/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Hot Cross-linking (Iqbal CXL)
Official scientific title Evaluation of a New Technique to Increase The Corneal Cross-linking Efficacy by Raising The Corneal Temperature During Ultra-Violet Light A Corneal Irradiation (Hot Cross-linking) for Kearatoconus Treatment
Brief summary describing the background and objectives of the trial Cornea Is resistant to destruction by cold (up to -70°C) and heat (up to +80°C). lowering the corneal temperature before CXL may increase oxygen diffusion into the cornea thus increasing CXL efficacy. However, the new idea of hot CXL proposed by Professor Mohammed Iqbal is to increase the corneal temperature during CXL to reach from 38°C to 39°C to test the corneal behavior and response to CXL in such high temperature.
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 01/03/2020
Actual trial start date
Anticipated date of last follow up 01/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
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
Control Group SCXL group once 3 months Standard CXL (Conventional epithelium-off CXL) , 14 minutes soaking time with riboflavin, 30 minutes UVA corneal irradiation continuous mode 20 Active-Treatment of Control Group
Experimental Group First HCXL Group once 3 months same procedure as in the standard CXL but special heaters will be used to raise the corneal temperature to 37°C which will be checked with a non-contact infrared thermometer before start UVA irradiation. 10
Experimental Group Second HCXL Group once 3 months same procedure as in the standard CXL but special heaters will be used to raise the corneal temperature to 38°C which will be checked with a non-contact infrared thermometer before start UVA irradiation. 10
Experimental Group Third HCXL Group once 3 months same procedure as in the standard CXL but special heaters will be used to raise the corneal temperature to 39°C which will be checked with a non-contact infrared thermometer before start UVA irradiation. 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age from 18 to 30 years old Grade 1,2 and 3 Keratoconus No previous interventions clear cornea Advanced Keratoconus Age below 18 years old opacities Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 30 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 10/02/2019 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 HOSPITAL SOHAG UNIVERSITY STREET SOHAG CITY 82425 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohammed Iqbal 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
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 Clinical Study Report,Statistical Analysis Plan,Study Protocol Within 12 months of the study completion date 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 within 12 months of the study completion date 01/01/2020 01/03/2020
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/uploads/733/1549554373%20-%20Hot%20CXL.pdf
Changes to trial information