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.: PACTR201711002679332 Date of Approval: 10/10/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of reformation of the anterior chamber by air or balanced salt solution (BSS) on corneal endothelium after phacoemulsification
Official scientific title Effect of reformation of the anterior chamber by air or balanced salt solution (BSS) on corneal endothelium after phacoemulsification
Brief summary describing the background and objectives of the trial to compare the effect of reformation of the anterior chamber of the eye by air and by balanced salt solution on the corneal endotheliam by specular microscopic examination after phacoemulsification
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied cataract,Eye Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/10/2016
Actual trial start date 10/10/2016
Anticipated date of last follow up 17/05/2017
Actual Last follow-up date 25/05/2017
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 40
Recruitment status Completed
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Reformation of anterior chamber by air one one to inject air in anterior chamber of the eye 25
Control Group reformation of anterior chamber by balanced salt solution one one to inject balanced salt solution in the anterior chamber of the eye 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
cataract patient need to be treated by phacoemulsification unclear cornea corneal dystrophy low corneal endothelial count 52 Year(s) 67 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 09/10/2017 Sohag faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Sohag university Sohag 82511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome change in corneal endothelial count preoperative postoperative 1 month postoperative 3 months
Secondary Outcome Change in corneal edema Preoperative Postoperative 1 month Postoperative 3 month
Secondary Outcome Change in corneal edema Preoperative Postoperative 1 month Postoperative 3 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sohag University Hospital, Sohag university,Ophthalmology department Sohag 82511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sohag University Sohag university Sohag 82511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Sohag University hospital Sohag university,Ophthalmology department Sohag 82511 Egypt Hospital
Primary Sponsor Sohag University Sohag university Sohag 82511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Alahmady Hamad Sohag university,Ophthalmology department Sohag 82511 Egypt
Mohamed Ezz El Dawla Sohag university,Ophthalmology department Sohag 82511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amr Amr dramrmonir@yahoo.com 01005026170 Sohag university,Ophthalmology department
City Postal code Country Position/Affiliation
Sohag 82511 Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Ahmad Moustafa amoustafa77@hotmail.com 01021777683 Sohag university
City Postal code Country Position/Affiliation
Sohag 82511 Egypt
Role Name Email Phone Street address
Scientific Enquiries Alahmady Hamad alahmady20@yahoo.com 0111102698 Sohag university,Ophthalmology department
City Postal code Country Position/Affiliation
Sohag 82511 Egypt Assistant professor
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