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.: PACTR202007641877021 Date of Approval: 21/07/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between femtosecond laser assisted and conventional cataract surgery
Official scientific title Outcomes of femtosecond laser cataract surgery in an Egyptian cohort: a comparative study
Brief summary describing the background and objectives of the trial Cataract is the leading cause of preventable blindness worldwide. Femtosecond laser assistedcataract surgery(FLACS) is a recent technology that aims to reduce the complications and improve outcomes of cataract surgery.The aim of the study was to compare safety and visual outcomes of femtosecond laser-assisted cataract surgery to conventional phacoemulsification.
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: Devices
Anticipated trial start date 01/01/2018
Actual trial start date 15/03/2018
Anticipated date of last follow up 30/06/2019
Actual Last follow-up date 01/09/2019
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 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 Femtosecond laser assisted cataract surgery single intervention, 5 to 15 minutes Removal of the crystalline lens through a small incision after fragmentation using femtosecond laser 50
Control Group Conventional phacoemulsification single intervention, 5-10 minutes Removal of the crystalline lens using ultrasonic fragmentation 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Cataract patients with age from 40 to 70 years. Deep set eyes corneal opacity poorly dilatable pupil (less than 5 mm) intumescent cataract glaucoma advanced DR wet AMD optic nerve atrophy. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 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 24/02/2018 Research committee of EyeCare eye hospital
Ethics Committee Address
Street address City Postal code Country
1 Dimask street, Maadi Cairo 16332 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ultrasound total time. CummulativeDissipated Energy..Amount of irrigation fluid used..Endothelial cell loss Intraoperative for US total time, CDE and irrigatuing fluid volume..3 months for endothelial cell loss
Secondary Outcome Uncorrected visual acuity UCVA, Best corrected visual acuity BCVA 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of OphthalmologyCairo University Kasr Al Ainy hospital , Manial Cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Icare center Ezbet el Nozha street, Semouha alexandria 21648 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Eye care surgical center 1 Demeshk street, Maadi Cairo 11742 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Icare eye center Ezbet El-Nozha Alexandria 21648 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yehia Salah El Din Mostafa yehiasalah323@gmail.com +201005555108 1 Demeshk street, Maadi
City Postal code Country Position/Affiliation
Cairo 11742 Egypt Professor of Ophthalmology Cairo University
Role Name Email Phone Street address
Scientific Enquiries Ahmed Sherif ahmedsherif@kasralainy.edu.eg +201221088299 1 Aswan square, Mohandessin
City Postal code Country Position/Affiliation
Giza 12654 Egypt Associate Professor of Ophthalmology Cairo University
Role Name Email Phone Street address
Public Enquiries Ahmed Gharib afhgharib@gmail.com +201006502035 Ezbet el Nazer, Semuha
City Postal code Country Position/Affiliation
Alexandria 21648 Egypt Ophthalmology specialist Ministry of health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Will individual participant data will be shared: yes What data in particular will be shared: Individual participant data that underlie the results reported in the article after deidentification (texts, tables, figures) What other documents will be available: Study protocol When will data be available (start and end dates): Immediately following publication. No end date With whom: Anyone who wishes to access the data For what type of analysis: For individual participant data meta-analysis By what mechanism will data be made available: Manuscript will be available at journal website and via contact information of the corresponding author Study Protocol Data be available (start and end dates): Immediately following publication.Expected within 6 months No end date wishes to access the data For whWith whom: Anyone whoat type of analysis: For individual participant data meta-analysis By what mechanism will data be made available: Manuscript will be available at journal website and via contact information of the corresponding author Data will be available for any researcher who requests it for meta-analysis or as a reference Manuscript will be available at journal website and via contact with any of the authors Corresponding author contact information will be provided with manuscript
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not yet available 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