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.: PACTR201701001843366 Date of Approval: 30/10/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Corneal collagen cross linking for treatment of infectious keratitis
Official scientific title Corneal collagen cross linking with photoactivated riboflavin [ PACK- CXL ] as adjunctive therapy for treatment of infectious keratitis
Brief summary describing the background and objectives of the trial This study aims for evaluating efficacy and safety of corneal collagen cross linking for treatment of infectious keratitis
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Infectious keratitis
Sub-Disease(s) or condition(s) being studied Infectious keratitis
Purpose of the trial Treatment: Other
Anticipated trial start date 30/09/2016
Actual trial start date 30/09/2016
Anticipated date of last follow up 30/10/2017
Actual Last follow-up date 30/10/2017
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Medical treatment for infectious keratitis plus CXL Once 3 months Medical treatment for infectious plus CXL 39 Active-Treatment of Control Group
Control Group Medical treatment for infectious keratitis Once 3 months Medical treatment for infectious keratitis based on sensitivity reports 39 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- patients with clinically suspected infectious keratitis confirmed by both direct smears and cultures. 2- central corneal thickness of more than 400 microns with epithelium as measured by AS- OCT. 3- Infiltrates involving less than 250 microns depth of corneal thickness 4- patients more than 18 years 1- Perforated corneal ulcers or impending perforation 2- Scleral involvement or near limbus by 1 mm 3- Total corneal involvement. 4- Evidence of endophthalmitis. 5- viral keratitis 6- known Allergy to study medications 7- Pregnancy 8- NO PL 18 Year(s) 80 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 20/07/2015 IRP Committee faculty of medicine zagazig university
Ethics Committee Address
Street address City Postal code Country
Faculty of medicine Zagazig 44222 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Healing rate and period for study groups After 3 months for each group
Secondary Outcome Uncorrected and best corrected visual acuity (UCVA and BCVA) for study groups After 3 months for each group
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ophthalmology department Zagazig university Hospitals Faculty of Medicine Zagazig 44222 Egypt
Outpatient clinics Zagazig university Hospitals Faculty of medicine Zagazig 44222 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Main contributor expense Fellat el Gamaa Zagazig 44111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Main contributor Fellat el Gamaa Zagazig 44111 Egypt Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Mohammed Mohammed Mahdy Tawfeek 28 Osman Ibn Affan Street Zagazig 44111 Egypt
Prof Dr. Mohammed Bahgat Awad Ophthalmology department Zagazig 44111 Egypt
Prof. Dr. Wael Osman El Haieg Ophthalmology department Zagazig 44111 Egypt
Mohammed Mohammed Mahdy Tawfeek 28 Osman Ibn Affan Street Zagazig 44111 Egypt
Prof Dr. Mohammed Bahgat Awad Ophthalmology department Zagazig 44111 Egypt
Prof. Dr. Wael Osman El Haieg Ophthalmology department Zagazig 44111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Tawfeek Dr_mahdy_1984@yahoo.com 00201228898496 Osman ibn Affan street - Fellat El Gamaa
City Postal code Country Position/Affiliation
Zagazig 44111 Egypt Assistant lecturer ophthalmology department Zagazig university
Role Name Email Phone Street address
Public Enquiries Mohammed Tawfeek Dr_mahdy_1984@yahoo.com 00201228898496 Fellat El Gamaa
City Postal code Country Position/Affiliation
Zagazig Egypt Assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries Mohammed Tawfeek Dr_mahdy_1984@yahoo.com 00201228898496 Fellat El Gamaa
City Postal code Country Position/Affiliation
Zagazig 44111 Egypt Assistant lecturer ophthalmology department Zagazig university
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information