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.: PACTR201706002163811 Date of Approval: 31/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparitive study of Argon Laser and Aspirin in treatment of central serous chorioretinopathy
Official scientific title Comparitive study of Argon Laser and Aspirin in treatment of central serous chorioretinopathy
Brief summary describing the background and objectives of the trial Group A: treated with acetylsalicylic acid 150 mg per day orally for 6 months . Group B: treated with Argon Laser in grid treatment once Group C: treated with Argon Laser in grid treatment once followed by acetylsalicylic acid 150 mg per day orally for 6 months. Follow up clinically by evaluation of visual acuity and anatomically by OCT every month for six months was done.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) no
Disease(s) or condition(s) being studied defective vision,Eye Diseases,Genetic Diseases,Injury, Occupational Diseases, Poisoning,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 07/01/2014
Actual trial start date 17/02/2016
Anticipated date of last follow up 12/10/2016
Actual Last follow-up date 12/10/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Stopped early/ terminated
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 randomisation by tables created by computer number containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group laser once once laser application alone 20
Experimental Group aspirin alone 150mg daily 6 months aspirin orally 20
Experimental Group laser and aspirin laser once aspirin 150 mg dailly 6 months 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
central serous chorioretinopathy classic within 500 Um from centre of fovea multifocal 19 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 15/05/2016 sohag university
Ethics Committee Address
Street address City Postal code Country
mohafza street sohag 82324 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome laser with aspirin better than each alone 6 months
Primary Outcome visual acuity visual acuity improvement by sentinels chart
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
sohag faculty of medicine Mohafza street sohag 82324 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no source
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sohag university 21 nahda street sohag 82324 Egypt University
COLLABORATORS
Name Street address City Postal code Country
amr monir 2 alsmman street sohag 82324 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator alahmady alsmman alahmady20@yahoo.com 00201111102698 21 nahda street
City Postal code Country Position/Affiliation
sohag 82324 Egypt sohag university
Role Name Email Phone Street address
Principal Investigator alahmady alsmman alahmady20@yahoo.com 00201111102698 21 nahda street
City Postal code Country Position/Affiliation
sohag 82324 Egypt sohag university
Role Name Email Phone Street address
Public Enquiries gamal radwan gamalradwan8@gmail.com 00201001244421 12 algomhoria street
City Postal code Country Position/Affiliation
sohag 82324 Egypt sohag faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries engy mostafa engymostafa@yahoo.com 00201005643587 22 alzahraa street
City Postal code Country Position/Affiliation
sohag 82324 Egypt sohag faculty of mediine
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information