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.: PACTR202102825518454 Date of Registration: 22/02/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Corneal Collagen Cross-linking (CXL) versus Combined CXL and Femtosecond Laser-assisted Intra-corneal Ring Segment Implantation for Treatment of Keratoconus
Official scientific title Corneal Collagen Cross-linking (CXL) versus Combined CXL and Femtosecond Laser-assisted Intra-corneal Ring Segment Implantation for Treatment of Keratoconus
Brief summary describing the background and objectives of the trial This work aims at comparing visual, refractive, and topographic outcomes, contrast sensitivity and high order aberrations (by Pentacam criteria) in patients with keratoconus who underwent corneal collagen cross-linking (CXL) with those who underwent combined CXL and ICRS insertion using femtosecond laser.
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 01/01/2017
Actual trial start date 16/02/2017
Anticipated date of last follow up 01/01/2019
Actual Last follow-up date 20/07/2019
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Corneal collagen crosslinking Riboflavin and ultraviolet light exposure 40 minutes It is a surgery to stabilize the cornea in keratoconus patients 30 Active-Treatment of Control Group
Experimental Group Surgery Riboflavin and ultraviolet light exposure with insertion of intracorneal ring segments 60 minutes Surgery to stabilize the cornea and induce mechanical flattening in keratoconus 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Eyes with progressive keratoconus Presence of the clear central cornea. Corrected visual acuity (VA) of less than 20/40. Intolerance to contact lenses. A minimum central corneal thickness of 400 μm for the CXL procedure, and a minimum peripheral corneal is a thickness of 450 μm at the planned incision sites for ring implants. K reading values from 48 D - less than 65 D. Severe keratconus (keratometric values of 65.0 D or more). Acute hydrops, corneal haze or opacity. Presence of active or recent ocular infection or inflammation. Collagen disease, and pregnancy or lactation during the study. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 18 Year(s) 36 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 16/07/2017 Federalwide Assurance for the protection of the human subjects
Ethics Committee Address
Street address City Postal code Country
AL khartoom square Alex 21500 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome visual acuity Preoperative, 3months, 6 months and one year follow up
Primary Outcome Refraction Preoperative, 3months 3 months, and 6 months and one year follow up
Primary Outcome Topographic outcomes Preoperative, 3months 3 months, and 6 months and one year follow up
Secondary Outcome Contrast sensitivity Preoperative, 3months 3 months, and 6 months and one year follow up
Secondary Outcome Coma High order aberrations Preoperative, 3months 3 months, and 6 months and one year follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Roaya eye center 52 toot ankh amun Street, sidi gaber Alexandria 21500 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Seham Abdallah Ahmed saad Ahmed bn abdelwahab Alexandria 21500 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine university of Alexandria AL khartoom square Alexandria 21500 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Elmassry Mustafa Kamel Alexandria 21500 Egypt
Ehab Osman Roshdy Alexandria 21500 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Seham Abdallah Sehamabdallah83@yahoo.com 00201014164955 Ahmed bn abdelwahab
City Postal code Country Position/Affiliation
Alexandria 21500 Egypt Ministry of health
Role Name Email Phone Street address
Public Enquiries Seham Abdallah sehamabdallah83@yahoo.com 00201014164955 Ahmed bn abdelwahab
City Postal code Country Position/Affiliation
Alexandria 21500 Egypt Ministry of health
Role Name Email Phone Street address
Scientific Enquiries Seham Abdallah sehamabdallah83@yahoo.com 00201014164955 Ahmed bn Abdelwahab
City Postal code Country Position/Affiliation
Alexandria 215000 Egypt Ministry of health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data to be shared includes that underlie the results reported in this series article, after the deidentification (text, tables, figures, and other appendices) Study Protocol Beginning 48 months and ending 3 months following article publication Access with investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose. For individual participant meta-analysis. Proposal should be directed to sehamabdallah83@yahoo.com. To gain access, data requestors will need to sign a data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 18/02/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 18/02/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information