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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901740831583 Date of Registration: 29/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Single triangle versus Fox pentagon Frontalis Sling.
Official scientific title Single Triangle versus Fox Pentagon Frontalis Suspension for Severe Congenital Ptosis Correction.
Brief summary describing the background and objectives of the trial Frontalis suspension is a well-known surgical procedure for the correction of congenital ptosis with poor levator function (less than 4 mm).There are many sling patterns without consensus on the optimal one: single loop, double loop, and single-strip design.Single loop design includes different shapes: pentagonal, rectangular, and triangular. Fox pentagon frontalis suspension is one of the most commonly-used techniques without any logical reason being evident. In spite of the theoretical simplicity of the single triangle sling design; there are a few reports on its use in the literature. The purpose of this study is to compare the functional and cosmetic outcomes of two different frontalis sling designs for correction of severe congenital ptosis: single triangle and Fox pentagon technique.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 15/10/2017
Actual trial start date 15/10/2017
Anticipated date of last follow up 01/06/2019
Actual Last follow-up date 01/12/2019
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Completed
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 Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Single triangle group 2 years Upper lid crease and single suprabrow incisions are made. Using a large curved reverse cutting needle, the PTFE (Gore-Tex CV2) sling is passed in a retroseptal plane through the upper lid in a monotriangular configuration The sling is directly sutured to the tarsus and frontalis muscle. 30
Control Group Fox pentagon group 2 years Upper lid crease and three suprabrow incisions are made. Using a large curved reverse cutting needle, the PTFE (Gore-Tex CV2) sling is passed in a retroseptal plane through the upper lid in a pentagon configuration. The sling is directly sutured to the tarsus and frontalis muscle. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Unilateral or bilateral severe ptosis Weak levator function (<4 mm). Poor Bell's phenomenon Jaw winking phenomenon Blepharophimosis syndrome Myopathic disorders Adolescent: 13 Year(s)-17 Year(s),Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 18 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 11/10/2017 Fayoum university Faculty of Medicine Ethical Committee.
Ethics Committee Address
Street address City Postal code Country
Kiman fares square Fayoum 63521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Margin reflex distance 1 1 month, 3 months , 6 months, 1 year, and 2 years
Primary Outcome Sling linkage 1 month, 3 months, 6 months, 1 year, and 2 years
Secondary Outcome Eyelid contour 6 months, 1 year, and 2 years
Secondary Outcome Lid contour 6 months, 1 year, and 2 years
Secondary Outcome Forehead scarring 6 months, 1 year, and 2 years
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fayoum University Hospitals Kiman Fares AL Fayoum Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mostafa Diab 10 George Nirose St Al Mesalla Fayoum Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Fayoum University Hospital Ophthalmology department Kiman Fares AL Fayoum Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mahmoud Kamal Yakken Eye Center AL Hadekka Fayoum Egypt
Nora Mahmoud Al Gamaa square behind sports stadium Fayoum Egypt
Mohammed Abdel Hafez AL Mokattam Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Diab mmd11@fayoum.edu.eg +201091168842 10 George Nirose St, Al Mesalla
City Postal code Country Position/Affiliation
AL Fayoum Egypt Associate Professor of Ophthalmology Fayoum University Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Nora Mohammed dr.noraahmed@hotmail.com +201028770043 AL Nabawy AL Mohandes St
City Postal code Country Position/Affiliation
AL Fayoum Egypt Resident of Ophthalmology at Fayoum Insurance Hospital
Role Name Email Phone Street address
Scientific Enquiries Mostafa Diab mmd11@fayoum.edu.eg +201091168842 10 George Nirose St, AL Mesalla
City Postal code Country Position/Affiliation
Al Fayoum Egypt Associate Professor of Ophthalmology Fayoum University Faculty of Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information