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.: PACTR201901615323963 Date of Approval: 14/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of femtosecond laser energy on corneal endothelium in femtosecond laser assisted deep anterior lamellar keratoplasty.
Official scientific title Comparison of the effects of femtosecond laser energy on the corneal endothelium at two different dissection levels in femtosecond laser-assisted deep anterior lamellar keratoplasty for keratoconus patients.
Brief summary describing the background and objectives of the trial This is the first prospective study to compare the effects of femtosecond laser energy on the corneal endothelium at two different dissection levels in femtosecond laser-assisted deep anterior lamellar keratoplasty for keratoconus patients. The study will comprise two groups in which femto-dissection will be done at 80 or 110 microns anterior to the Descemet's membrane at the corneal thinnest location. The effects of femtosecond laser energy on corneal endothelial cells will be compared by specular microscopy at 1,3 and 6 months postoperative.
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 16/05/2018
Actual trial start date 17/05/2018
Anticipated date of last follow up 16/05/2019
Actual Last follow-up date 14/08/2019
Anticipated target sample size (number of participants) 20
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 laser assisted deep anterior lamellar keratoplasty once at 80 microns anterior to the thinnest location femtosecond laser application takes 30 seconds in average replacement of the host's diseased corneal stroma (keratoconus) by donor healthy stroma using femtosecond laser assisted deep anterior lamellar keratoplasty 10
Control Group femtosecond laser assisted deep anterior lamellar keratoplasty once at 110 microns anterior to thinnest location average of 30 seconds replacement of diseased stroma by healthy donor tissue 10 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age from 18 to 40 years Grade 3 or 4 keratoconus according to Amsler Krumeich classification No previous ocular or corneal surgery or trauma No associated ocular disease Apical corneal scarring precluding specular microscopy Previous ocular or corneal surgery Associated eye disease Adolescent: 13 Year-18 Year,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 23/05/2018 Research Ethics Committee of Faculty of Medicine Ain Shams university
Ethics Committee Address
Street address City Postal code Country
Abbaseya Cairo 202268575 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Effect on specular microscopy one, three and six months postoperative
Secondary Outcome safety on corneal endothelium one, three and six months postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals Abbaseya square Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mustafa Saber 11 Ansary street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mustafa Saber 11 Ansary street Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Ashraf Soliman Abbaseya Cairo Egypt
Ismail Hamza Abbaseya Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mustafa Saber dr.mustafa.saber@gmail.com 01276720263 11 Ansary street
City Postal code Country Position/Affiliation
Cairo Egypt Assistant lecturer of Ophthalmology at Ain Shams university
Role Name Email Phone Street address
Public Enquiries Mustafa Saber dr.mustafa.saber@gmail.com +21276720263 11 Ansary street
City Postal code Country Position/Affiliation
cairo Egypt Assistant lecturer of Ophthalmology at Ain Shams university
Role Name Email Phone Street address
Scientific Enquiries Mustafa Saber dr.mustafa.saber@gmail.com +201276720263 11 Ansary street
City Postal code Country Position/Affiliation
Cairo Egypt Assistant lecturer of ophthalmology at Ain Shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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