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.: PACTR201810577524718 Date of Approval: 15/10/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Corneal safety and stability in cases of Small incision lenticule extraction with collagen cross-linking (SMILE Xtra)
Official scientific title Corneal safety and stability in cases of Small incision lenticule extraction with collagen cross-linking (SMILE Xtra)
Brief summary describing the background and objectives of the trial Even though SMILE offers better biomechanical stability for the cornea, there are reports of cases of post SMILE ectasia in the literature. A simultaneous combination of SMILE procedure and CXL (SMILE Xtra) was prescribed to further strengthen the cornea in doubtful cases to decrease the risk of postoperative ectasia and may theoretically decrease the myopic regression. Purpose: to assess the safety and stability in cases of small incision lenticule extraction with collagen cross-linking (SMILE Xtra).
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 Prevention
Anticipated trial start date 22/12/2017
Actual trial start date
Anticipated date of last follow up 25/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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 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
Control Group SMILE alone 24 months SMILE surgery alone without crosslinking. follow up period 24 months 30 Active-Treatment of Control Group
Experimental Group SMILE Xtra 24 months SMILE plus crosslinking (SMILE Xtra) plus 24 months follow up 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients > 18 years of age Myopic error of > 6 D Thinner cornea < 520 microns, Abnormal corneal topography. Associated corneal pathology, Established keratoconus, Corneal thickness < 450 microns Hyperopia or mixed astigmatism. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 21/12/2017 local ethics committe of faculty of medicine alexandria university Egypt
Ethics Committee Address
Street address City Postal code Country
faculty of medicine, alexandria university, 17 Champollion street, El Mesalah, Alexandria, Egypt Alexandria 21259 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome UDVA, CDVA 24 months
Secondary Outcome corneal bimechanical stability.. corneal resistance factor CRF 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FAculty of medicine alexandria university khartoum square alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded authors Ihab OSman Hany Helaly. 30 roshdy street alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of mediicne alexandria university khartoum square alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
ihab osman roshdy alexandria Egypt
hany ahmed helaly roshdy alexandria Egypt
mohsen aboushousha roshdy alexandria Egypt
amir abousamra roshdy alexandria Egypt
islam ahmed roshdy alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ihab osman osmanehab@yahoo.com +201225466733 roshdy street
City Postal code Country Position/Affiliation
alexandria Egypt Assistant professor faculty of medincine. alexandria. egypt
Role Name Email Phone Street address
Public Enquiries mohsen aboushousha drmohsenmd@hotmail.com +201225466733 roshdy street
City Postal code Country Position/Affiliation
alexandria Egypt Assistant professor faculty of medincine. alexandria. egypt
Role Name Email Phone Street address
Scientific Enquiries hany helaly hany209209@yahoo.com +201225466733 roshdy street
City Postal code Country Position/Affiliation
alexandria Egypt Assistant professor faculty of medincine. alexandria. egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes There was a significant difference between the 2 groups regarding UDVA, CDVA, and MRSE at 1 month. In SMILE Xtra group, 90 % of eyes had postoperative UDVA of 20/20 and 97 % had UDVA of 20/30 at 24 months. At 24 months, 26 eyes (87 %) vs. 25 eyes (84 %) were within + 0.50 D of attempted correction in SMILE Xtra and SMILE groups respectively. Regarding stability, both groups showed improvement of MRSE at 1st month postoperative and remained stable along the 24 months of follow up. CRF and corneal densitometry was higher in SMILE Xtra group along the whole follow up period (p = 0.001). 12/10/2018 12/10/2018
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks Not available
Changes to trial information