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.: PACTR202001690996005 Date of Approval: 21/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Frontalis muscle flap for severe unilateral congenital ptosis correction.
Official scientific title Frontalis Muscle flap versus Silicone Frontalis Sling for severe Unilateral congenital ptosis correction.
Brief summary describing the background and objectives of the trial Congenital blepharoptosis is defined as the congenital maldevelopment of the levator palpebrae superioris musclepresent since birth. Congenital blepharoptosis does not simply cause cosmetic problems, but is also frequently associated with refractive errors, strabismus, and amblyopia, which may affect the visual function. In eyelids with poor levator function (less than 4 mm), the preferred treatment is frontalis suspension surgery, using different materials included fascia lata, and alloplastic materials (silicon, polytetrafluoroethylene, non-absorbable sutures). (5-8)It creates a direct link between the frontalis muscle and the tarsal plate of the upper eyelid, so that the frontalis muscle can be used to elevate the eyelid indirectly. However, the application of alloplastic material can be associated with the risk of foreign-body reaction and local inflammation. Autogenous fascia lata has several drawbacks such as the need for a second operative site, scarring on the leg, and difficulty to harvest from children. (9-10) The frontalismuscle flap (FMF) advancement is considered an alternative to standard frontalis suspension. The FMF can be considered an autogenous frontalis suspensionin which the frontalis muscle is dissected and directly transposed to the upper lid tarsus. It avoids complications from the linking material such as foreign-body reaction, absorption, granuloma formation and late exposure, and the need for a second visible incision on the forehead, or any extra incisions at the donor site.(11-13) In this study we compare the functional and aesthetic outcome of Silicone frontalis suspension versus autogenic frontalis muscle flap advancement for correction of unilateral severe congenital ptosis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 14/07/2019
Actual trial start date 14/07/2019
Anticipated date of last follow up 14/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
M 204 Fayoum University Scientific Research Ethics Committee
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Frontalis muscle flap 6 months Fifteen patients with congenital unilateral severe ptosis are corrected by frontalis flap advancement. 15
Control Group Silicone Frontalis suspension 6 months Patients with unilateral severe congenital ptosis will be treated with silicone frontalis suspension. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Patients with unilateral severe congenital ptosis. 2- Poor levator function (< 4mm). 1- Mild or Moderate congenital ptosis (MRD 1 >1mm). 2- Absent Bell’s phenomenon. 3- Patients with jaw winking phenomenon, blepharophimosis syndrome, and myopathic disorders. 4- Previous ptosis surgery. 5- Follow up less than 6 months. Adolescent: 13 Year-18 Year,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 14/07/2019 Fayoum University Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Kiman Fares Square Fayoum 63514 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Margin Reflex Distance 1 1,3,6 months
Secondary Outcome Link 1,3,6 months
Secondary Outcome Lid crease symmetry 6 months
Secondary Outcome Lid contour 6 months
Secondary Outcome Lid height symmetry 6 months
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 Mohammed Mohammed Diab 12 George Nirose St, Al Mesalla Fayoum 63523 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fayoum University Hospitals Kiman Fares Fayoum Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mostafa Mohammed Mohammed Diab 12 George Nirose St, Al mesalla Fayoum 63523 Egypt
Ahmed Ali Ali Ebrahim 48 betcho american city, Zahraa Maadi Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Diab mmd11@fayoum.edu.eg +201016737314 11 Gorge Narous St, from El Nabawy El Mohandes St
City Postal code Country Position/Affiliation
Fayoum Egypt Lecturer of Ophthalmology at Fayoum university Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Mahmouid Kamal drmahmoudkamal@yahoo.com +201223102811 14 Mesaddak St, El Dokki
City Postal code Country Position/Affiliation
Giza Egypt Professor of Ophthalmology
Role Name Email Phone Street address
Scientific Enquiries Mostafa Diab mmd11@fayoum.edu.eg +201016737314 11 Gorge Narous St, from El Nabawy El Mohandes, Al Mesalla
City Postal code Country Position/Affiliation
Fayoum Egypt Lecturer of Ophthalmology Fayoum University
Role Name Email Phone Street address
Principal Investigator Ahmed Ebrahim dr.aliali86@yahoo.com +201111736021 48 Betcho American city, Zahraa Maadi
City Postal code Country Position/Affiliation
Cairo Egypt Private center
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes M 204 Protocol ID Study Protocol 1 year controlled access, by email, Ophthalmology Department at Fayoum University Hospital, .
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