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.: PACTR201803003209297 Date of Approval: 18/03/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Cross-Linking on Corneal Endothelium
Official scientific title Evaluation of The Safety of Corneal Cross-Linking on The Corneal Endothelium in the Treatment of Keratoconus
Brief summary describing the background and objectives of the trial This study aims to detect any harmful effects of CXL on the corneal epithelium in treatment of keratoconus.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Endothelium in CXL
Disease(s) or condition(s) being studied Eye Diseases,Keratoconus
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 20/04/2018
Actual trial start date
Anticipated date of last follow up 20/10/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Accelerated CXL Once 18 minutes Accelerated epithelium-off CXL, 10 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation pulsed mode. 15 Active-Treatment of Control Group
Experimental Group Standard CXL Once 60 minutes Standard epithelium-off CXL, 30 minutes soaking time with riboflavin, 30 minutes UVA corneal irradiation continuous mode 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Grade 1, 2 or 3 Keratoconus. Age from 10 to 40 years. Clear cornea. Corneal thickness more than 400 um. Grade 4 keratoconus. Age more than 40 years. Corneal opacity. Corneal thickness less than 400 um. 10 Year(s) 40 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 20/03/2018 Mohammed Iqbal Hafez Saleem
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 Endothelial cell density Before surgery. One week after surgery. One month after surgery. Three months after surgery.
Secondary Outcome Endothelial morphology. Before surgery. One week after surgery. One month after surgery. Three months after surgery.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University Hospital Chamblion street, el azareeta, Alexandria Governorate Alexandria 21526 Egypt
Sohag University Hospital University Street, Naser City sohag 82425 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria University Hospital Chamblion street, el azareeta, Alexandria Governorate Alexandria 21526 Egypt
Sohag University Hospital University Street, Naser City Sohag 82425 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria University Hospital Chamblion street, el azareeta, Alexandria Governorate Alexandria 21526 Egypt Hospital
Secondary Sponsor Sohag University Hospital 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
Mohammed Iqbal Hafez Saleem Sohag University Hospital sohag 82425 Egypt
Amani E Badawi Mansoura University, 60 El Gomhoureya St., El mansoura, El dakahleya, Mansoura, Egypt Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator 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.
Role Name Email Phone Street address
Public Enquiries Amani Badawi amanibadawi37@yahoo.com +20 100 381 8271 Mansoura University, 60 El Gomhoureya St., El mansoura, El dakahleya, Mansoura, Egypt
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Ophthalmology, Mansoura University Hospital
Role Name Email Phone Street address
Scientific Enquiries 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.
REPORTING
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