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.: PACTR201807153376731 Date of Approval: 23/07/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Lower lid trachomatous trichiasis correction
Official scientific title Correction of lower lid trachomatous trichiasis using anterior lamellar recession versus tarsotomy procedure.
Brief summary describing the background and objectives of the trial Randomised clinical trial of 40 patients with lower lid trachomatous trichiasis which will be assigned 20 patients to anterior lamellar recession group (group A) and 20 patients to the tarsotomy group(group B).This study is to compare the out come of anterior lamellar recession (ALR) and tarsotomy surgery for treatment of lower lid trachomatous trichiasis as regards recurrence and cosmetic outcome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Lower lid trachomatous trichiasis
Sub-Disease(s) or condition(s) being studied Lower lid trachomatous trichiasis
Purpose of the trial Treatment: Surgery
Anticipated trial start date 10/06/2018
Actual trial start date 15/06/2018
Anticipated date of last follow up 01/03/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
M334 ethical committee , faculty of medicine, fayoum university
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Anterior lamellar recession 1year Lower lid levator splitting and anterior lamellar repositioning 25
Control Group Tarsotomy procedure 1 year Lower lid horizontal tarsal incision with everting sutures 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Lower lid trachomatous trichiasis with one or more eyelashes touching the eye or evidence of epilation, in association with tarsal conjunctival scaring. Non trachomatous trichiasis. Involution entropion. Previous eyelid surgery. Severe conjunctival scaring mandating posterior lamellar graft. Age less than 18 years old Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 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 10/06/2018 Fayoum university faculty of medicine ethical committee
Ethics Committee Address
Street address City Postal code Country
Kyman fares square Fayoum 11311 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Recurrence of trichiasis At 1 week, 1month, 3months, 6 months and 1 year
Secondary Outcome Corneal status 1 week, 1month, 3 months, 6 months and 1 year.
Secondary Outcome Dry eye parameters (TBUT, Schirmer test) 1 month, 3 months, 6 months and 1 year
Secondary Outcome Cosmetic outcome 6 months and 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fayoum university hospital Kyman fares square Fayoum 2308 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Fayoum university hospital Kyman fares square Fayoum 2308 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fayoum university hospital Kyman fares square Fayoum 2308 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof. Mahmoud Ahmed Kamal Kyman fares square Fayoum 2308 Egypt
Fatma Mohamed ahmed Kyman fares square Fayoum 2308 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Diab mmd11@fayoum.edu.eg 00201091168842 11 George Nirose St, From EL Nabawy El Mohandes St, AL Mesalla, AL Fayoum
City Postal code Country Position/Affiliation
Fayoum 63523 Egypt Lecturer of Ophthalmology, fayoum university, faculty of medicine
Role Name Email Phone Street address
Public Enquiries Fatma Mohamed Dr.fatema89@yahoo.com 00201005779762 Kyman fares square
City Postal code Country Position/Affiliation
Fayoum 2308 Egypt Resident of ophthalmology
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Kamal Drmahmoudkamal@yahoo.com 00201223102811 Kyman fares square
City Postal code Country Position/Affiliation
Fayoum 2308 Egypt Professor of ophthalmology, faculty of medicine, fayoum university
Role Name Email Phone Street address
Scientific Enquiries Mostafa Diab mmd11@fayoum.edu.eg 00201091168842 11 George Nirose ST, Al Mesalla, Al Fayoum
City Postal code Country Position/Affiliation
Fayoum 63523 Egypt Lecturer of ophthalmology, faculty of medicine, fayoum university
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