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.: PACTR202004601235101 Date of Registration: 16/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Maximal levator resection versus modified tarsectomy for correction of congenital ptosis with fair levator function.
Official scientific title Surgical correction of congenital ptosis with fair levator function.
Brief summary describing the background and objectives of the trial Congenital ptosis usually results from levator palpebrae superioris muscle dysgenesis, and is characterized by reduced levator function (LF) Correction of congenital ptosis is surgical with the Levator function and severity of ptosis determine the selection of surgical technique. Patients with poor LF (less than 4 mm) are usually treated with frontalis sling procedures. Good or excellent LF (8–12 mm and 13 mm, respectively) can be corrected by levator advancement or Mullerectomy procedures. However, the technique of choice is less clear in patients with congenital ptosis and fair LF (5–7 mm). Obtaining satisfactory long-term results in this patient group is challenge. Current techniques include maximal levator resection, Whitnall sling procedures with or without superior tarsectomy, or frontalis suspension. In this study, we will compare modified trasectomy versus maximal levator resection for correction of congenital ptosis with fair levator function.
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 01/05/2020
Actual trial start date
Anticipated date of last follow up 01/04/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
R 113 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 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
Control Group maximal levator resection 6 month follow-up - General anesthesia - Lid crease incision. - Dissection of levator- Muller's muscle flap with Whitnall's ligament release. - The amount of levator resection depends on the severity of ptosis. 20 Active-Treatment of Control Group
Experimental Group Modified tarsectomy 6 months Follow-up -General anesthesia. - Lid crease incision - Dissection of the levator aponeurosis from underlying Muller's muscle. - The anterior face of tarsus was exposed by reflection of pretarsal orbicularis. - A caliper was used to measure and mark the height of tarsus and Muller muscle to be excised. - The amount of tissue resection depends on the degree of ptosis 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with congenital ptosis with fair lavator function (5-7 mm) Marcus Gunn Jaw winking phenomenon Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 40 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 12/04/2020 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 Margin reflex distance 1 1,3,6 months
Primary Outcome Cosmetic results lid contour, height symmetry, lid crease 6 months
Primary Outcome Lagophthalmos 1, 3, 6 months
Secondary Outcome exposure keratopathy 1,3,6 months
Secondary Outcome Ocular Surface Evaluation A. Schirmer’s test 2: This is performed with Schirmer tear test strips without anesthetic eyedrops. A result ≥10 mm after 5 minutes was considered normal. B. Tear break-up time (TBUT): This is determined by the number of seconds that elapse between the last blink and the appearance of the first superficial punctate keratitis. A TBUT result >10 seconds is considered normal.15 C. Fluorescein staining: This is performed by the application of a fluorescein strip to the lower fornix, and the extent of staining is scored on a scale of 0–3 according to the stained area: 0 = no staining, 1 = staining of less than one-third of the cornea, 2 = staining of one third to two-thirds of the cornea, and 3 = staining of more than two-thirds of the cornea. 0, 7, 30, 90 postoperative days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fayoum University hospital Kiman fares District Fayoum Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mostafa Mohammed Mohammed Diab 11 George Nirose From Elnabaey ALmesalla fayoum Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fayoum University Hospital Kiman Fares district Fayoum Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Shereen Hassan Sadek 2/7 Zahraa El Maadi Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Diab mmd11@fayoum.edu.eg +201016737314 11 George Nirose St, from Elnabawy St, Al Mesalla
City Postal code Country Position/Affiliation
Fayoum Egypt Lecturer of Ophthalmology Fayoum University
Role Name Email Phone Street address
Public Enquiries Shereen Sadek Sh.sadek@gmail.com +2010632012 2/7 Zahraa EL Maadi
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of ophthalmology Fayoum University
Role Name Email Phone Street address
Scientific Enquiries Mostafa Diab mmd11@fayoum.edu.eg +201016737314 11George Nirose St, Al mesalla
City Postal code Country Position/Affiliation
Fayoum Egypt Lecturer of Ophthalmology Fayoum University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Preoperative information demographic data, ptosis assessment postop (functional and cosmetic outcomes) Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 year controlled
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