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.: PACTR201708002498199 Date of Approval: 03/08/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Mechanical versus femtolaser corneal flaps assessment
Official scientific title Assessment of corneal flap thickness and symmetry in the optical center using anterior segment optical coherence tomography; mechanical versus femtolaser flaps
Brief summary describing the background and objectives of the trial To evaluate corneal flap thickness in the central 3 mm for subjects underwent either LASIK or Femto- LASIK for correction of myopia and/ or astigmatism
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Refractive errors
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 03/05/2016
Actual trial start date 03/05/2016
Anticipated date of last follow up 24/11/2016
Actual Last follow-up date 24/11/2016
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants) 160
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 Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling 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 Corneal flap creation Corneal flap creation by Moria microkeratome 80
Experimental Group Corneal flap creation Corneal flap creation by Femtolaser 80
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Myopic patients with refraction less than -6.00 D, astigmatism less than -3.00 D and a stable keratometry after cessation of soft contact lens wear for at least 2 weeks or rigid gas-permeable contact lens wear for at least 4 weeks with K reading value ranging between 41.50 and 45.00 D. The patients never had a previous kerato-refractive surgery and the corneal pachymetry was ¿ 520 µm at the thinnest location. Patients who do not fit the inclusion criteria or with history of herpetic eye disease, corneal dystrophy, corneal scarring because of infection or trauma, keratoconus, severe dry eye, collagen vascular disease, cataract, retinal disease, diabetes mellitus, pregnancy and who showed intraoperative and postoperative complications. 19 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 07/03/2016 Ethical Committee of the Menoufia University Hospital.
Ethics Committee Address
Street address City Postal code Country
Abdel Ghaffar Street Shebin El Kom 32145 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Corneal flap thickness three months after the procedure
Secondary Outcome Corneal flap symetry three months after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tiba Eye center El Glaa Street Shebin El Kom 21345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
None
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor None University
COLLABORATORS
Name Street address City Postal code Country
Abdel Rahman El Sebaey Sarhan Shebin el Kom 233455 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdel Rahman El Sebaey Sarhan rahman_sebaey@yahoo.com 201003196169 Menoufia University Hospital street
City Postal code Country Position/Affiliation
Egypt Menoufia University
Role Name Email Phone Street address
Public Enquiries Asmaa Ibraheem khsemsem@yahoo.com 201002415485 Menoufia University Hospital street
City Postal code Country Position/Affiliation
Egypt
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abd Elaziz m_samy06@yahoo.com 201003876617 Menoufia University Hospital street
City Postal code Country Position/Affiliation
Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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