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.: PACTR202112789322278 Date of Registration: 17/12/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Double flap technique for unilateral congenital ptosis.
Official scientific title Frontalis flap versus combined frontalis flap and levator resection for unilateral congenital ptosis.
Brief summary describing the background and objectives of the trial Unilateral amblyogenic ptosis presents a great challenge for the oculoplastic surgeon with no consensus on the ideal technique. There are increasing reports on the use of frontalis flap as autogenous procedure for correction of congenital ptosis. However this procedure remains non physiologic as the neurological wiring to clear the visual axis is third nerve mediated while frontalis muscle based procedures depend on facial nerve. The purpose of this study is to compare the functional and cosmetic outcomes of frontalis flap alone versus combined frontalis flap and levator resection for amblyogenic unilateral 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 15/12/2021
Actual trial start date
Anticipated date of last follow up 01/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
R 200 The Scientific Research Ethics Committee of Fayoum University 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 Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Frontalis flap 6 months - Frontalis flap is fashioned through a lid crease approach. - The flap is passed in the retropseptal space to be attached to the tarsal plate. - The lid crease incision is closed picking bites through the inferior edge of the flap. 15 Active-Treatment of Control Group
Experimental Group Double flap 6 months - A frontalis flap is fashioned through a lid crease incision. - Levator muscle is dissected from overlying fat and underlying tissue. - Both the levator muscle and frontalis flap are sutured to the tarsal plate. - The lid crease is closed picking bites through the inferior edge of the levator flap. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Children having unilateral severe simple congenital ptosis. - Poor levator function < 4mm. - Myopathic ptosis. - Neurogenic ptosis. - Recurrent ptosis. Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 12 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
No 24/11/2021 Fayoum University Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Kiman Fares district Fayoum 63514 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - Eyelid height 1, 3, 6 momths
Primary Outcome Eyelid contour 1,3,6 months
Primary Outcome Lagophthalmos in millimeters on gentle lid closure and at midnight. 1,3,6 months
Secondary Outcome Eyelid crease 1,3,and 6 months
Secondary Outcome Blinking rate and quality 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fayoum University hospitals Kiman Fares district Fayoum Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mostafa Mohammed M. Diab 12 George Nirose St, Al Mesalla, Al FAyoum Fayoum Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fayoum University Kiman Fares district Fayoum Egypt University
COLLABORATORS
Name Street address City Postal code Country
Richard C Allen 6565 Fannin St, Houston Houston United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Diab mmd11@fayoum.edu.eg +201016737314 12 George Nirose St, Al mesalla
City Postal code Country Position/Affiliation
Fayoum Egypt Department of Ophthalmology Faculty of Medicine Fayoum University
Role Name Email Phone Street address
Public Enquiries Mostafa Diab mmd11@fayoum.edu.eg +201016737314 12 George Nirose St, Al mesalla
City Postal code Country Position/Affiliation
Fayoum Egypt Department of Ophthalmology Faculty of Medicine Fayoum University
Role Name Email Phone Street address
Scientific Enquiries Mostafa Diab mmd11@fayoum.edu.eg +201016737314 12 George Nirose St, Al mesalla
City Postal code Country Position/Affiliation
Fayoum Egypt Department of Ophthalmology Faculty of Medicine Fayoum University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data that support the findings of this study are available upon reasonable request from the corresponding author, after deidentification. The data are not publicly available due to their containing information that could compromise the privacy of research participants.. Analytic Code,Study Protocol Data will be available beginning 9 months following trial completion date for researchers who provide a methodologically sound proposal Data will be available beginning for researchers who provide a methodologically sound proposal to the principal investigator.
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