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.: PACTR201804003256258 Date of Approval: 27/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between Refractive Outcomes of Femtosecond Laser Assisted Cataract Surgery and Standard Phacoemulsification
Official scientific title Comparison between Refractive Outcomes of Femtosecond Laser Assisted Cataract Surgery and Standard Phacoemulsification
Brief summary describing the background and objectives of the trial Purpose: to compare the visual and refractive outcomes of femtosecond laser assisted cataract surgery (FLACS) using Victus platform (Technolas B&L, Munich, Germany) and conventional phacoemulsification cataract surgery (CPCS).
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Surgery,visual and refractive outcome
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2017
Actual trial start date 01/01/2017
Anticipated date of last follow up 31/12/2017
Actual Last follow-up date 31/12/2017
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 Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group flacs surgery femtosecond laser assissted cataract surgery 50
Control Group cpcs surgery conventional phacoemulsification cataract surgery 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age range of 18-80 years visually significant cataract The included cataract patients had an age range of 18-80 years having visually significant cataract excluding cases of glaucoma, corneal opacity, macular diseases, and any other problem expected to affect vision. 18 Year(s) 80 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 02/11/2016 Local ethics committe of faculty of medicine, alexandria university, Egypt
Ethics Committee Address
Street address City Postal code Country
khartoum square Alexandria 21259 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1- Uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) at 1 month and 6 months following surgery
Secondary Outcome 2- Refractive error (spherical as well as astigmatic refractive errors in both magnitude and axis) at 1 month and 6 months following surgery
Secondary Outcome 3- Root mean square (RMS) total eye aberrations, lower order and higher order aberrations (coma, trefoil, and spherical aberrations) measured by I-Trace ray tracing aberrometer 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine, Alexandria University, Egypt Khartoum Square Alexandria 21259 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
authors khartoum square alexandria 21259 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor authors khartoum square alexandria 21259 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Shafik Shaheen khartoum square alexandria 21259 Egypt
Amir AbouSamra khartoum square alexandria 21259 Egypt
Hany Ahmed Helaly khartoum square alexandria 21259 Egypt
Amr Said khartoum square alexandria 21259 Egypt
Ahmed Elmassry khartoum square alexandria 21259 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohame Shafik Shaheen m.shafik@link.net 00201005534280 khartoum square
City Postal code Country Position/Affiliation
alexandria 21259 Egypt professor faculty of medicine, alexandria, egypt
Role Name Email Phone Street address
Public Enquiries Amr Said docamro1@hotmail.com 002035437074 khartoum square
City Postal code Country Position/Affiliation
alexandria 21259 Egypt lecturer, faculty of medicine, alexandria, egypt
Role Name Email Phone Street address
Scientific Enquiries Hany Helaly hany209209@yahoo.com 00201112241229 khartoum square
City Postal code Country Position/Affiliation
alexandria 21259 Egypt assistant professor faculty of medicine, alexandria, egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 04/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Purpose of the trial 04/07/2018 pactr update Treatment: Other Treatment: Surgery
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 04/07/2018 pactr update Other Eye Diseases, Surgery, Other