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.: PACTR201711002708423 Date of Approval: 20/10/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of endothelial cell changes by specular microscopy between Ringers and Ringer¿s Lactate during Phacoemulsification
Official scientific title Comparison of endothelial cell changes by specular microscopy between Ringer¿s and Ringers Lactate during Phacoemulsification
Brief summary describing the background and objectives of the trial Purpose: to investigate whether there was a significant difference between using Ringers and Ringers Lactate (RL) solutions when used as irrigating solutions during phacoemulsification and their effect on corneal endothelium.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied corneal endothelial changes,Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/05/2017
Actual trial start date
Anticipated date of last follow up 01/10/2017
Actual Last follow-up date 03/10/2017
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 computer software "Randomizer" at https://www.randomizer.at computer program "Randomizer" https://www.randomizer.at ...... was used for simple randomisation Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group lactated ringer's irrigation solution during surgery time irrigation during phacoemulsification 50
Control Group ringer's solution irrigation in surgery during surgery time irrigation during phaco 50
Control Group ringer's solution irrigation in surgery during surgery time irrigation during phacoemulsification 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
uneventful phaco coexisting corneal pathologies, uveitis, dense brown cataract, glaucoma, diabetes, previous ocular surgery, any intraoperative complication or excessive manipulations affecting corneal endothelial integrity, and preoperative endothelial cell count less than 1500 cells/mm3. 18 Year(s) 70 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 01/12/2016 Local ethics committe of Faculty of Medicine, Alexandria University
Ethics Committee Address
Street address City Postal code Country
khartoum square alexandria Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome endothelial cell changes 3 months
Secondary Outcome best corrected visual acuity 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine, Alexandria University Khartoum square Alexandria 21259 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Authors Khartoum square Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Authors Khartoum square Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
Authors Khartoum square Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hany Helaly hany209209@yahoo.com 00201225466733 Khartoum square
City Postal code Country Position/Affiliation
Alexandria 21259 Egypt Assistant professor, Faculty of Medicine, Alexandria Univ, Egypt
Role Name Email Phone Street address
Public Enquiries Eman Desouky emandesoky2000@gmail.com 00201112241229 Khartoum square
City Postal code Country Position/Affiliation
Alexandria 21259 Egypt
Role Name Email Phone Street address
Scientific Enquiries Amir Abousamra amirabousamra@gmail.com 00201225466733 Khartoum square
City Postal code Country Position/Affiliation
Alexandria 21259 Egypt
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