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.: PACTR201703002136186 Date of Approval: 24/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Economic aspect comparison between vitrectomy and scleral buckle
Official scientific title An economy-based study, Vitrectomy ve­rsus Scleral buckle for primary rhegmato­genous retinal detac­hment in poor popula­tion
Brief summary describing the background and objectives of the trial The objective of the study is to compare the efficacy and safety of vitrectomy and scleral buckle in addition to evaluation of the economic aspects of both techniques for management of retinal detachment.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Retinal detachment
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 24/12/2013
Actual trial start date 23/01/2014
Anticipated date of last follow up 21/01/2016
Actual Last follow-up date 26/05/2016
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 45
Recruitment status Stopped early/ terminated
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
Parallel: different groups receive different interventions at same time during study Non-randomised Sealed opaque envelope Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Non-randomised Sealed opaque envelope Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Vitrectomy Once Vitrectomy 25 Active-Treatment of Control Group
Control Group Scleral buckle Once Scleral buckle 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria are eyes having phakic RD with clear lens, no or grade B PVR and single or multiple breaks. Exclusion criteria were eyes with PVR more than grade B, retinal dialysis, giant retinal tears, ocular trauma and diabetic retinopathy. 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 15/10/2013 Ethical committee of Faculty of Medicine, South valley University
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, South Valley University Qena Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Efficacy and safety 1 year postoperatively
Primary Outcome Economy based evaluation of both techniques 1 year postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
department of ophthalmology South valley university Qena Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Hasan Mohamed Department of Ophthalmology, South Valley University Qena Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Walid Ibrahim Department of Ophthalmology, Assiut University Assiut Egypt University
COLLABORATORS
Name Street address City Postal code Country
Walid Ibrahim Ophthalmology Department, Assiut University Assiut 71516 Egypt
Ahmed H. Mohamed Ophthalmology Department, South Valley University Qena Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Mohamed ahmedhasandoghaimy@gmail.com +201008675936 Ophthalmology Department - South Valley University Hospital
City Postal code Country Position/Affiliation
Qena Egypt
Role Name Email Phone Street address
Public Enquiries ZEIAD Eldaly dr_ziadeldaly@yahoo.com +201094544721 Ophthalmology Department, Assiut University
City Postal code Country Position/Affiliation
Assiut 71516 Egypt
Role Name Email Phone Street address
Scientific Enquiries Walid Ibrahim walidmohame72@gmail.com +201223971491 Ophthalmology Department, Assiut University
City Postal code Country Position/Affiliation
Assiut 71516 Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
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