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.: PACTR201901821397773 Date of Approval: 17/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title SMILE vs WFG-LASIK in correction of myopic astigmatism
Official scientific title Comparison between Small Incision Lenticule Extraction and Wavefront-Guided Femtosecond Laser-Assisted In Situ Keratomileusis in Correction of Myopic Astigmatism.
Brief summary describing the background and objectives of the trial SMILE was first introduced in 2011 as a flap-free intrastromal laser assisted refractive surgery technique for the correction of myopia and myopic astigmatism. To date, this technique lacks automated centration and cyclotorsion control, so several concerns have been raised regarding its capability to correct moderate or high levels of astigmatism. On the other hand, wavefront–guided LASIK is performed using a pupil-tracking system and iris registration technique that are intended to obtain a more accurate alignment and correction of astigmatism in corneal refractive surgery. So, this study will compare between these two procedures regarding the visual and optical outcome in patients with myopic astigmatism.
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 15/10/2018
Actual trial start date
Anticipated date of last follow up 15/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
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 Femtosecond assisted wavefront guided LASIK once 3 months Steps of femtosecond assisted LASIK, A: docking, B: creation of the flap using femtosecond laser, C: separation of the flap using a spatula, D: complete elevation of the flap from the bed, E: application of excimer laser, F: reposition of the flap back to the bed. 15
Control Group Small incision lenticule extraction once 3 months steps of femtosecond lenticule extraction, A: spiral in, B: spiral out, C: cap edge and incision, D: separation of lenticule from the undersurface of the cap then from the stromal bed, E: extraction of lenticule through the incision using forceps, F: checking the integrity and completeness of the lenticule. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age: 18 years or older. 2, Simple or compound myopic astigmatism. 3. Stable refractive error over the past year. 4. A clear cornea without any active inflammation. 5. A clear lens and a healthy posterior segment. 1. Unstable refraction. 2. Ectatic disorders (such as keratoconus). 3. Severe dry eyes. 4. Pregnancy. 5. Collagen vascular diseases and inflammatory disorders such as Rheumatoid arthritis. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 25/11/2018 Faculty of Medicine Ain Shams University Research Ethics Committee REC FWA 000017585
Ethics Committee Address
Street address City Postal code Country
Abbasia, Cairo, Egypt cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Achieve post operative uncorrected visual acuity equal or better than preoperative spectacle corrected visual acuity 3 months
Secondary Outcome achieving good quality of vision with less aberrations 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Mashreq Eye Center 102 Al-Said Al-Merghani st ,El-Montaza, Qism El-Nozha Cairo 11586 Egypt
Faculty of Medicine Ain Shams University Abbasia Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Khaled Mohamed Al Boraie 60 algalaa st Damietta 34511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ashraf Hassan Soliman 6B Botros Ghaly st, Misr El Gididaa Cairo 11341 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Ashraf Hassan Soliman 6B Botros Ghali Cairo 11757 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Khaled Al Boraie kmi429@yahoo.com +201115161749 60 al galaa st
City Postal code Country Position/Affiliation
Damietta 34511 Egypt ophthalmology resident
Role Name Email Phone Street address
Principal Investigator Ashraf Soliman kmi429@yahoo.com +201228155553 6B Botros Ghaly st, Misr El Gididaa
City Postal code Country Position/Affiliation
Cairo 11341 Egypt Consultant Ophthalmologist
Role Name Email Phone Street address
Public Enquiries Mohammad Gamil mgamil001@yahoo.com +201110888823 Abbasia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt professor of ophthalmology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes patient's info: name, age, sex, date of operation, type of operation preoperative: refraction, topography, wavescan postoperative: uncorrected visual acuity, topography, wavescan Informed Consent Form,Study Protocol 3 months open
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