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.: PACTR201804003282725 Date of Approval: 01/04/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Accelerated versus standard CXL
Official scientific title Comparison of Accelerated Corneal Collagen Cross-linking (CXL) versus Standard CXL
Brief summary describing the background and objectives of the trial the main aims are to detect the stability and reliability of accelerated CXL when compared with standard CXL
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Keratoconus,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2015
Actual trial start date 01/01/2015
Anticipated date of last follow up 09/06/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 89
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
Sohag University Hospital Ethical Committee \ no 883 for year 2013
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 randomisation using a radomisation 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 Standard CXL Once 60 minutes riboflavin 30 minutes then UVA corneal irradiation 30 minutes 38 Active-Treatment of Control Group
Experimental Group Accelerated CXL Once 18 minutes Accelerated epithelium-off CXL, 10 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation pulsed mode. 51
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age less than 35 years old Grade 1,2 and 3 Keratoconus No previous interventions Corneal opacity Previous Hydrops Age more than 35 years 12 Year(s) 35 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 11/05/2014 Sohag University Hospital
Ethics Committee Address
Street address City Postal code Country
Sohag University Hospital sohag 82425 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Stability and prevention of KC progression k readinds pachymetry
Secondary Outcome Corneal flattening and visual improvement visual acuity refraction
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University Hospital Chamblion street, el azareeta, Alexandria Governorate Alexandria 21526 Egypt
Mohammed 0 Iqbal ophthalmology department sohag 82425 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sohag University Hospital Sohag University Hospital sohag 82425 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohammed Iqbal Hafez Saleem Sohag University Hospital sohag 82425 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ahmed El-Massry 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 01068559840 Sohag University Hospital
City Postal code Country Position/Affiliation
sohag 82425 Egypt Assistant Professor of Ophthalmology, Sohag University Hospital.
Role Name Email Phone Street address
Public Enquiries Ahmed Tawfik atawfika@gmail.com 01000089352 Koliat Al Tob St, Shaibet an Nakareyah, Markaz El-Zakazik,
City Postal code Country Position/Affiliation
zagazig 44519 Egypt Professor of ophthalmology, Zagazig University Hospital.
Role Name Email Phone Street address
Scientific Enquiries Ahmed El-Massry ahmad.elmassry@gmail.com +20 122 215 2435 Chamblion street, el azareeta, Alexandria Governorate
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of ophthalmology, Alexandria University Hospital.
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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