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.: PACTR201703002113756 Date of Approval: 18/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ologen in primary congenital glaucoma
Official scientific title A Comparative Study; The Use of Collagen Implant Versus Mitomycin-C in Combined Trabeculotomy And Trabeculectomy For Treatment of Primary Congenital Glaucoma
Brief summary describing the background and objectives of the trial Congenital glaucoma (CG) is a major cause of blindness in children. Combined trabeculotomy and trabeculectomy is the most common procedure for congenital glaucoma in our locality. The aim of this study is to compare collagen implant (Ologen) versus mitomycin-C (MMC) in combined trabeculotomy and trabeculectomy as a treatment of primary congenital glaucoma.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Congenital glaucoma,Eye Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2014
Actual trial start date 01/04/2014
Anticipated date of last follow up 31/07/2015
Actual Last follow-up date 31/10/2015
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 18
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
1185/247 Ethics committee of Sohag faculty of medicine
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 Non-randomised 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
Experimental Group Ologen implantation Cylindrical piece of ologen Not removed Combined trabeculotomy and trabeculectomy with collagen matrix implant 9
Control Group Mitomycin C 0.4 mg/ml 2 minutes Combined trabeculotomy and trabeculectomy with MMC application 9 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age less than three years primary congenital glaucoma History of lacrimation, photophobia, blepharospasm and or eye enlargement Signs of elevated IOP, increased corneal diameters, corneal haze and or increased cup-to- disc ratio. Secondary glaucoma Patients with other ocular pathology, e.g. congenital cataract, Patients with previous ocular surgery including glaucoma surgery Patients who could not adhere to the follow up schedule 1 Day(s) 3 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 21/10/2013 Sohag Faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Madinet Naser Sohag 82745 Egypt
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 21/10/2013 Sohag Faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Madinet Naser Sohag 82745 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intraocular pressure One month Six months 12 months
Secondary Outcome Transverse corneal diameter One month Six months 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sohag University Hospital Madinet Nasser Sohag Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sohag University hospital Madinet Nasser Sohag 82745 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Sohag university Madinet Nasser Sohag 82745 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mortada A. Abozaid Madinet Nasser Sohag 82745 Egypt
Alaa Abd El-Sadek Madinet Nasser Sohag 82745 Egypt
Osama Ali Mohammed Madinet Nasser Sohag 82745 Egypt
Mohammed Iqbal Hafez Madinet Nasser Sohag 82745 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alaa Abd El-Sadek alaabdelsadek24@yahoo.com +20164037382 madinet nasser
City Postal code Country Position/Affiliation
sohag 82745 Egypt Resident
Role Name Email Phone Street address
Public Enquiries Mohammed Iqbal Saleem dr_m_iqbal@yahoo.com +20168559840 madinet nasser
City Postal code Country Position/Affiliation
sohag 82745 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Mortada Abozaid Mourtada_abdelaal@med.sohag.edu.eg +201203324446 madinet nasser
City Postal code Country Position/Affiliation
sohag 82745 Egypt Lecturer
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