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.: PACTR202105861579646 Date of Registration: 26/05/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Toric IOL in keratoconus
Official scientific title Toric Intraocular Lens Implantation after Phacoemulsification Cataract Surgery in Patients with Keratoconus
Brief summary describing the background and objectives of the trial Patients with keratoconus and cataract will be divided into 2 groups; Group A will have a toric IOL implanatation and Group B will have a spherical IOL implanatation. The 2 groups will be followed up to 6 months to compare their visual and refractive outcomes.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/06/2021
Actual trial start date
Anticipated date of last follow up 01/06/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Toric IOL For ever Toric IOL is implanted at the end of cataract surgery 30
Control Group Spherical IOL For ever Spherical IOL is implanted at the end of cataract surgery 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with stable keratoconus and visually significant age-related cataract with normal fundus and normal intraocular pressure (IOP). corneal opacity or low endothelium endothelial cell count (<2000 cell/mm), poor pupillary dilatation, pseudo-exfoliation Syndrome, glaucoma, uveitis, history of eye trauma or surgery other than cross-linking. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 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 10/05/2021 Medical Research Ethics Committee Sohag University Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Madinet Nasser Sohag 82135 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual acuity 6 months
Secondary Outcome Refraction 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sohag University hospital Madinet Nasser Sohag 82135 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sohag university hospita Madinet Nasser Sohag 82135 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sohag University Madinet Nasser Sohag 82135 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mortada Abozaid mourtada_abdelaal@med.sohag.edu.eg +201203324446 Algomhoreya street
City Postal code Country Position/Affiliation
Sohag 82136 Egypt Ass. Professor
Role Name Email Phone Street address
Public Enquiries Mortada Abozaid mourtada_abdelaal@med.sohag.edu.eg +201203324446 Algomhoreya street
City Postal code Country Position/Affiliation
Sohag 82136 Egypt Ass. Professor
Role Name Email Phone Street address
Scientific Enquiries Mortada Abozaid mourtada_abdelaal@med.sohag.edu.eg +201203324446 Algomhoreya street
City Postal code Country Position/Affiliation
Sohag 82136 Egypt Ass. Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All data will be uploaded to a repository and shared Statistical Analysis Plan,Study Protocol within one year of completion Data could be shared on reasonable request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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