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.: PACTR201811618954630 Date of Approval: 23/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Computer Vision Syndrome in Egypt
Official scientific title Survey of the Computer Vision Syndrome and Its Sequelae Among Medical Students in Egypt
Brief summary describing the background and objectives of the trial The study will include 4000 individuals. The study group will include 4000 Medical Students from 5 Egyptian Universities. From these 4000 students, only students with no CVS complains will be considered as the control group while the remaining number of students will be considered as the experimental group. All students with 5 or more CVS complains will be considered risk group and together with a similar number of students from control group identified as mini-control group will be subjected to ophthalmological examination including refraction, visual acuity. Dry Eye tests, slit-lamp and fundus examinations for diagnosis of CVS.. A sample of medical students from both mini-control and risk groups will be subjected to multi-focal ERG in Minia University to detect any harms of CVS on retina and these students wiyh mfERG examination will be identified as mfERG group.
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 Diagnosis / Prognosis
Anticipated trial start date 24/11/2018
Actual trial start date 24/11/2018
Anticipated date of last follow up 01/09/2019
Actual Last follow-up date 10/12/2019
Anticipated target sample size (number of participants) 4000
Actual target sample size (number of participants) 4030
Recruitment status 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 Randomised Simple randomization using a randomization table created by a computer software program 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 Ophthalmological examination in surveyed non complaining medical students once 2 weeks visual acuity, refraction, Dry Eye tests. slit-lamp and fundus examination of surveyed 100-500 medical students (with no complains of CVS manifestations) with same age match to detect CVS among them. 500 Placebo
Experimental Group Ophthalmological examination in surveyed complaining medical students once 4 weeks visual acuity, refraction, Dry Eye tests. slit-lamp and fundus examination of surveyed 3500-4000 medical students (with no complains of CVS manifestations) with same age match to detect CVS among them. 3500
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Medical students Any age In Egyptian Universities Corneal Opacities Retinal Diseases Optic Nerve Diseases CNS diseases Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 26 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 10/04/2018 Institutional Research Board in Faculty of Medicine Sohag University
Ethics Committee Address
Street address City Postal code Country
Sohag University Street Sohag City 82425 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Diagnoses of CVS in complaining medical students. Diagnoses of dry eye disease presentation in complaining medical students. Diagnosis of any possible harm of CVS on Retinal functions. At time of slit-lamp examination, fudus examination and mfERG
Secondary Outcome Sequelae of CVS on visual acuity, clarity of objects and any surveyed extraocular CVS manifestations. At time of visual acuity examination, subjective refraction and outcomes of CVS survey
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sohag University Hospitals Sohag University street Sohag City 82425 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohammed Iqbal Sohag University Street Sohag City 82425 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohammed Iqba Sohag University Street Sohag City 82425 Egypt Hospital
Secondary Sponsor Ahmed Elmassry Chamblion street, el azareeta, Alexandria Governorate Alexandria City 21526 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohammed Iqbal Sohag University Street Sohag City 82425 Egypt
Ahmed Elmassry Chamblion street, el azareeta, Alexandria Governorate Alexandria 21526 Egypt
Mervat Elgarib Suez Canal University Street Suez Canal 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Iqbal dr_m_iqbal@yahoo.com 00201068559840 Sohag University Street
City Postal code Country Position/Affiliation
Sohag City 82425 Egypt Assistant Professor of Ophthalmology in Sohag University Hospital.
Role Name Email Phone Street address
Public Enquiries Mervat Elgharieb mershabrawy63@yahoo.com 00201005163965 Suez Canal University Street
City Postal code Country Position/Affiliation
Suez Canal City 41522 Egypt Assistant Professor of Ophthalmology in Suez Canal University Hospital.
Role Name Email Phone Street address
Scientific Enquiries Ahmed Elmassry ahmad.elmassry@gmail.com 00201222152435 Chamblion street, el azareeta, Alexandria Governorate
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of ophthalmology in Alexandria University Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be allowed for sharing Clinical Study Report,Statistical Analysis Plan,Study Protocol 12 months after end of study ophthalmologists are allowed for access of data. they should email the principal investigator via dr_m_iqbal@yahoo.com to get the permission after reviewing the qualifications and quality of request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes The results summary will be available as a PDF including visual, refractive outcomes. Dry eye tests outcomes. Multifocal ERG in sever CVS cases. 01/01/2019 01/06/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks http://staffsites.sohag-univ.edu.eg/stuff/advs/show/5705?p=advs
Changes to trial information