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.: PACTR201804003284326 Date of Approval: 02/04/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Combined Vs Sequential ICRS and CXL
Official scientific title Comparison Between Combined versus Sequential Intrastromal Corneal Ring Segments and Corneal Collagen Cross-linking for Treatment of Keratoconus
Brief summary describing the background and objectives of the trial This research aims to evaluate the efficacy and safety of 2 procedures; CXL & ICRS,when performed together in the same session or sequentially to treat keratoconus
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 02/10/2014
Actual trial start date 02/10/2014
Anticipated date of last follow up 02/05/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 167
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
Ethical Commette , Sohag University Hospital Ethical Commette / no. 13 for year 2014 Sohag University Hospital
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 CXL 1st then ICRS after 6 months Once 6 months Standard epithelium-off CXL, 30 minutes soaking time with riboflavin, 30 minutes UVA corneal irradiation continuous mode. 6 months later kera rings are implanted with femtosecond laser 62 Active-Treatment of Control Group
Experimental Group ICRS 1st then CXL after 6 months Once 6 months Kera rings implantation with femtosecond laser. 6 months later, accelerated CXL, 10 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation pulsed mode. 58
Experimental Group combined ICRS and CXL Once 60 minutes 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. 47
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age less than 30 years old Grade 1,2 and 3 Keratoconus No previous interventions Follow up for 3 years Corneal opacity Previous Hydrops Age more than 30 years 12 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 11/05/2014 Ethical Commette ,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 3,6,12,24 and 36 postoperative months
Secondary Outcome Corneal flattening and visual improvement 3,6,12,24 and 36 postoperative months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sohag University Hospital Sohag University street sohag 82425 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sohag University Hospital Sohag University street sohag 82425 Egypt
Alexandria University Hospital Chamblion street, el azareeta, Alexandria Governorate Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohammed Iqbal ophthalmology department sohag 82425 Egypt Hospital
Secondary Sponsor Ahmed El-Massry Chamblion street, el azareeta, Alexandria Governorate Alexandria 21526 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohammed Iqbal ophthalmology department sohag 82425 Egypt
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 street
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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