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: www.pactr.org
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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 12/10/2018 layout correction e patients > 18 years of age , myopic error of > 6 D , thinner cornea < 520 microns, abnormal corneal topography. Patients > 18 years of age Myopic error of > 6 D Thinner cornea < 520 microns, Abnormal corneal topography.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 12/10/2018 Layout correction associated corneal pathology, established keratoconus, corneal thickness < 450 microns, hyperopia or mixed astigmatism. Associated corneal pathology, Established keratoconus, Corneal thickness < 450 microns Hyperopia or mixed astigmatism.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 12/10/2018 Correction to include all age groups Adult: 19 Year-44 Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 12/10/2018 did not know that self funded details should be added Self Funded authors Ihab OSman Hany Helaly., 30 roshdy street, alexandria, , Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 12/10/2018 missed from first input ihab osman, roshdy, alexandria, , Egypt
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 12/10/2018 missed from first input hany ahmed helaly, roshdy, alexandria, , Egypt
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 12/10/2018 missed from first input mohsen aboushousha, roshdy, alexandria, , Egypt
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 12/10/2018 missed from first input amir abousamra, roshdy, alexandria, , Egypt
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 12/10/2018 missed from first input islam ahmed, roshdy, alexandria, , Egypt
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 12/10/2018 missed from first input Undecided No
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results summary 12/10/2018 missed from first input 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).
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of results summaries 12/10/2018 missed from first input 12 Oct 2018
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of the first journal publication 12/10/2018 missed from first input 12 Oct 2018
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results & Publication URL 12/10/2018 missed from first input Results: 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).
Section Name Field Name Date Reason Old Value Updated Value
Reporting Baseline characteristics 12/10/2018 missed from first input Both SMILE Xtra and SMILE groups included 30 eyes of 15 patients. Table 1 shows the preoperative characteristics of included eyes of both groups. There was no statistically significant difference between the included patients of the 2 groups regarding the age and gender (p > 0.05). Eyes of the SMILE Xtra group had thinner and steeper corneas with more densitometry readings than that of SMILE group, but this was not statistically significant using independent samples t test (p > 0.05). Table 1: Preoperative characteristics of the included eyes (60 eyes of 30 patients divided equally on two groups). SMILE Xtra (n = 30) Mean + SD SMILE (n=30) Mean + SD P value Male: Female 10: 5 8: 7 0.456a Age (years) 24.3 + 5.9 25.2 + 5.1 0.640b MRSE (D) -8.6 + 1.1 -8.2 + 1.2 0.411b CDVA (logMAR) 0.048 + 0.06 0.042 + 0.07 0.341b CCT (microns) 495.1 + 22.6 498.4 + 21.1 0.245b K readings (D) 45.1 + 1.5 44.6 + 1.2 0.228b ECD (cells/mm2) 2816 + 288 2840 + 278 0.755b CRF 10.42  1.68 10.82  1.69 0.287b densitometry 17.31 + 1.90 16.51 + 1.71 0.299b MRSE: manifest refraction spherical equivalent, CDVA: corrected distance visual acuity, CCT: central corneal thickness, ECD: endothelial cell density, CRF: corneal resistance factor. a: Chi-square test, b: independent sample t test
Section Name Field Name Date Reason Old Value Updated Value
Reporting Participant flow 12/10/2018 missed from first input Ihab Mohamed Osman, MD: osmanehab@yahoo.com Hany Ahmed Helaly, MD: hany209209@yahoo.com Mohsen aboushousha, MD : drmohsenmd@hotmail.com Amir AbouSamra, MD,: amirabousamra@gmail.com Islam Ahmed, MD, FRCS(Glasg): I_Hamdy00@Alexmed.edu.eg
Section Name Field Name Date Reason Old Value Updated Value
Reporting Adverse events 12/10/2018 missed from first input none
Section Name Field Name Date Reason Old Value Updated Value
Reporting Outcome measures description 12/10/2018 missed from first input . Outcome data was recorded including UDVA, CDVA, manifest refraction, CCT, average keratometry, ECD, CRF, and corneal densitometry. Efficacy index (ratio of postoperative UDVA to preoperative CDVA) and safety index (ratio of postoperative CDVA to preoperative CDVA) were calculated. Predictability and stability of refractive correction was recorded. Any complication was also recorded.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Link to protocol 12/10/2018 missed from first input Purpose: to assess the safety and stability in cases of small incision lenticule extraction with collagen cross-linking (SMILE Xtra). Methods: This study was a retrospective interventional comparative study that included 60 eyes of 30 patients divided equally into two groups: SMILE Xtra and SMILE alone. The inclusion criteria were patients > 18 years of age, myopic error of > 6 D, thinner cornea < 520 microns, and abnormal corneal topography. Outcome data was recorded including uncorrected and c
Section Name Field Name Date Reason Old Value Updated Value
Reporting Outcome measure document 12/10/2018 missed from first input 3640_152_4738.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Participant flow document 12/10/2018 missed from first input 3640_152_4739.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 12/10/2018 missed from first input No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results & Publication URL 07/11/2018 Removed detail as this field should only contain URL Results: 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). Not available
Section Name Field Name Date Reason Old Value Updated Value
Reporting Adverse events 07/11/2018 edit none None
Section Name Field Name Date Reason Old Value Updated Value
Reporting Link to protocol 07/11/2018 Removed detail as field should only contain URL Purpose: to assess the safety and stability in cases of small incision lenticule extraction with collagen cross-linking (SMILE Xtra). Methods: This study was a retrospective interventional comparative study that included 60 eyes of 30 patients divided equally into two groups: SMILE Xtra and SMILE alone. The inclusion criteria were patients > 18 years of age, myopic error of > 6 D, thinner cornea < 520 microns, and abnormal corneal topography. Outcome data was recorded including uncorrected and c Not available