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.: PACTR201706002334350 Date of Approval: 01/06/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pars Plana Vitrectomy (PPV) with Internal Limiting Membrane (ILM) Peeling in Traumatic Macular Hole (TMH)
Official scientific title Pars Plana Vitrectomy (PPV) with Internal Limiting Membrane (ILM) Peeling in Traumatic Macular Hole (TMH): 14% Perflouropropane (C3F8) versus Silicon Oil Tamponade
Brief summary describing the background and objectives of the trial Traumatic macular hole is a problem commonly encountered.Surgical management isn't always needed. We try to investigate the outcome of 2 tamponading agents to manage it.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Surgery,traumatic macular hole
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Silicon Oil Tamponade
Anticipated trial start date 29/05/2009
Actual trial start date 31/05/2009
Anticipated date of last follow up 13/10/2010
Actual Last follow-up date 13/10/2010
Anticipated target sample size (number of participants) 33
Actual target sample size (number of participants) 26
Recruitment status Completed
Publication URL journal of ophthalmology, Hindawi publishing
Secondary Ids Issuing authority/Trial register
no no
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 computer software central random Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised computer software central random Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised computer software central random Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group silicon oil 4 ml at the end of surgery injection 10 Uncontrolled
Experimental Group perflouropropane 17 ml at the end of surgery injection 16
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
eyes with traumatic macular hole eyes with retinal detachment, vitreous haemorrhages, choroidal rupture 12 Year(s) 60 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 30/06/2016 zagzig faculty of medicine
Ethics Committee Address
Street address City Postal code Country
22 abozar street zagazig 22486 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 30/06/2016 zagzig faculty of medicine
Ethics Committee Address
Street address City Postal code Country
22 abozar street zagazig 22486 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome macular hole closure 6 months after surgery
Secondary Outcome visual acuity improvment 6 months post surgical
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ophthalmology department of zagazig university hospital 22 abozar street Zagazig 22486 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
nil nil nil nil Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ashraf Bor'i 22 elshraei street zagazig 22468 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ashraf Bor'i 22 elshraei street Zagazig 22486 Egypt
Mahmoud Alaswad 13 elmahareeth Zagazig 22468 Egypt
Ashraf Mahrous 11 madinty street New cairo 11345 Egypt
Ahmed Saad 33 tolba street Zagazig 45639 Egypt
Dina Rashad 33 tolba street Zagazig 45639 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ashraf Bor'i ashborai@yahoo.com 00201065338080 22 elshrai
City Postal code Country Position/Affiliation
Zagazig 22486 Egypt associate professor
Role Name Email Phone Street address
Public Enquiries Wael elhaig welhaig@hotmail.com 00201010001312 3 masaken elgamaa
City Postal code Country Position/Affiliation
Zagazig Egypt professor of ophthalmology
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Alaswad aseelaswad1@yahoo.com 00201000644604 mahareeth street
City Postal code Country Position/Affiliation
Zagazig Egypt assistant professor
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