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.: PACTR202102855369241 Date of Approval: 05/02/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pediatric cataract with Trematodal Granulomatous Uveitis
Official scientific title Surgical approach in cases of pediatric cataract with Trematodal Granulomatous Uveitis
Brief summary describing the background and objectives of the trial Pediatric infestation by a Trematodal fluke resulting in granulomatous uveitis is a recently described condition in India and Egypt. One of its most important complications is cataract which carry special difficulties in its evaluation and surgery.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Trematodal Infection
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/08/2020
Actual trial start date
Anticipated date of last follow up 31/01/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 10
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Cataract Surgery 6 month Removal of opaque cataract lens and implantation of IOL 10 Active-Treatment of Control Group
Experimental Group Cataract surgery in Complicated cataract to trematodal uveitis 6 months Removal of opaque cataract lens and implantation of IOL 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Complicated cataract Pediatric Trematodal Uveitis No active inflammation Previous surgery Active Uveitis 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 13/07/2020 Sohag Medical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Sohag University Street Sohag 82524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Difficulties in preparation for cataract surgery Preoperative
Primary Outcome Difficulties and complications during and after surgery Operative and postoperative
Secondary Outcome Corneal topography Preoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ophthalmology department in Sohag University Hospital University Street Sohag 85254 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mahmoud Mohamed Farouk Sohag University Street Sohag 82524 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sohag University Hospital Sohag University Street Sohag 82524 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Engy Mostafa Sohag University Street Sohag 82524 Egypt
Amr Mounir Sohag University Street Sohag 82524 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Farouk drmfaroukophth@yahoo.co.uk +201000400883 Sohag University Street
City Postal code Country Position/Affiliation
Sohag 82524 Egypt Assistant Professor
Role Name Email Phone Street address
Public Enquiries Amr Mounir amrmounir@med.sohag.edu.eg +201005026170 Sohag University
City Postal code Country Position/Affiliation
Sohag Egypt Lecturer of ophthalmology
Role Name Email Phone Street address
Scientific Enquiries Engy Mohamed engymostafa@yahoo.com +201005643587 Sohag University
City Postal code Country Position/Affiliation
Sohag Egypt Assistant Prof
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Study Protocol Beginning 9 months and ending 36 months following article publication Not applicable
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