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.: PACTR202008516974176 Date of Approval: 12/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Argon Laser for Trematodal Anterior Uveitis
Official scientific title Argon Laser Photocoagulation for Treatment of Trematodal Granulomatous Anterior Uveitis in Children
Brief summary describing the background and objectives of the trial Presumed trematodal-induced granulomatous anterior uveitis is a relatively common anterior uveitis among paediatrics from rural Egypt. I has been linked to swimming or bathing in the river nile and fresh water repertoire. Objective: to assess the safety and efficacy of Argon laser photocoagulation as a new modality for treatment of presumed trematodal-induced granulomatous anterior uveitis in a cohort o fEgyptian children
Type of trial CCT
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 17/05/2020
Actual trial start date 20/06/2020
Anticipated date of last follow up 30/09/2020
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 A link to be added
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
Experimental Group Argon laser one session 10-25 shots Under topical anesthesia, all cases received one session of Argon laser photocoagulation applied directly to the pearl-like lesions in the anterior chamber through the Argon laser lens. The settings of Argon laser werespot sizefrom 100 to 200 um, duration from 0.2 to 0.4 seconds, power varies from 250 to 400 mJ and number of shots varies from 10 to 25 shots according to the response which is whitinig and shrinkage of the lesion 15
Control Group Medical treatment prednisolone 0.1% 5 times daily with gradual withdrawal 2-4 weeks the following topical eyedrops were used:prednisolone 0.1% for 5 times daily with gradual withdrawal within 4weeks, cyclopentolate 3 times daily for 3 days and brimonidine 2 timesdaily for one week systemic steroid for one week and graduallywithdrawn 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients less than 18 year old presumed trematodal-inducedgranulomatous anterior uveitis one or two pearl-like masses in the AC visual acuity is better than 6/60 scarred membranous lesions cataract glaucoma phthisis history of ocular trauma or surgery Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 6 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 15/06/2020 Sohag medical research ethics committee
Ethics Committee Address
Street address City Postal code Country
Naser city Sohag 88905 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome resolution of uveatis 3 months
Secondary Outcome recurrence 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ophthalmology department of Sohag university hospital Madinet Naser Sohag 82145 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sohag Univesity hospital Madinet Naser Sohag 82145 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sohag university Madinet Naser Sohag Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alahmady Alsamman alahmady20@yahoo.com +201111102698 Algomhoreya street
City Postal code Country Position/Affiliation
Sohag Egypt Ass. professor of ophthalmology Sohag university
Role Name Email Phone Street address
Scientific Enquiries Mortada Abozaid mourtada_abdelaal@med.sohag.edu.eg +201203324446 Algomhoreya street
City Postal code Country Position/Affiliation
Sohag Egypt Ass. professor of ophthalmology Sohag university
Role Name Email Phone Street address
Public Enquiries Mohammed Ezzeldawla mohammedezz44@icloud.com +201000641164 Albahr street
City Postal code Country Position/Affiliation
Sohag Egypt lecturer of ophthalmology Sohag university
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 de-indentification will be shared Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately after publication, no end date Anyone who wishes to access the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
A link to be included 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