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.: PACTR202008627777341 Date of Approval: 18/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ICRS+CXL for Postlasik ectasia
Official scientific title Combined femtosecond laser-assisted intrastromal corneal corneal segments implantation and accelerated transepithelial corneal collagen cross-linking for post-lasik ectasia
Brief summary describing the background and objectives of the trial Post-lasik corneal ectasia is a serious complication of LASIK surgery and is usually detected in corneas that had significant central ablation with the excimer laser (high myopes). It consists of a progressive corneal steepening, usually inferiorly, with an increase in all ocular aberrations, and loss of uncorrected visual acuity (UCVA) and frequently best spectacle-corrected visual acuity (BSCVA) (1–4). This ectatic disorder has an estimated incidence that ranges from 0.04% to 0.6% (5) The specific mechanism resulting in these corneal alterations still remains unknown (2,4,6) The corneal weakening induced by the excimer laser ablation seems to have a significant role in the development of this complication (4,7,8) Several risk factors have been identified for the development of post-LASIK ectasia, such as the presence of a large preoperative myopic refractive error, a low residual stromal bed thickness a small modulus of elasticity or some corneal topographic abnormalities (2,4,5,6,9,10). A variety of therapeutic options have been described for the post-LASIK keratectasia, such as rigid gas permeable contact lenses, intracorneal ring segment (ICRS) implantation or corneal transplantation (2,8,11,12). The management of these patients must include visual rehabilitation because the visual function is devastated as the result of the significant increase in all ocular aberrations. The control of the keratectasia progression is another objective when treating these eyes. ICRS implantation has been proved effective in improving visual acuity, reducing the refractive error and keratometry. In addition, this kind of treatment has been demonstrated to be useful to prevent the need for keratoplasty and the progression of the iatrogenic cone (12,13).
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: Surgery
Anticipated trial start date 20/07/2020
Actual trial start date 04/08/2020
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ICRS and CXL Combined femtosecond laser-assisted intrastromal corneal corneal segments implantation and accelerated transepithelial corneal collagen cross-linking Time of surgery Combined femtosecond laser-assisted intrastromal corneal corneal segments implantation and accelerated transepithelial corneal collagen cross-linking 25
Control Group CXL only accelerated transepithelial corneal collagen cross-linking time of surgery accelerated transepithelial corneal collagen cross-linking 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients were more than 18 year old, had progressive postlasik ectasia (defined as 1 D increase in steepest keratometric reading over a 6-month period), poor BCVA (less than 6/18), clear central cornea and corneal thickness of more than 450 μm at the planned incision sites. eyes with corneal haze or opacity, advanced ectasia (keratometric values of more than 65.0 D), active ocular infection or inflammation and eyes with previous surgery (e.g. collagen cross-linking). Adult: 19 Year-44 Year 18 Year(s) 40 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 19/07/2020 medical research ethics committee of Sohag faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Madinet Naser Sohag 84321 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual outcome uncorrected and best-corrected visual acuity one year
Secondary Outcome Refractive and tomographic values one year
Secondary Outcome Progression of ectasia one year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ophthalmology department of Sohag university hospital Madinet Naser Sohag 84231 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sohag University hospital Madinet Naser Sohag Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sohag university Madinet Naser Sohag 84321 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 82789 Egypt Assistant professor of ophthalmology
Role Name Email Phone Street address
Scientific Enquiries Hatem Ammar hatemammar2@gmail.com +201000008375 City district
City Postal code Country Position/Affiliation
Sohag 82345 Egypt Professor of ophthalmology
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 82789 Egypt Assistant professor of ophthalmolgy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Sharing of all IPD preoperatively and postoperatively Informed Consent Form,Study Protocol immediately after publication any one who seeks the data
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