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.: PACTR201709002541488 Date of Approval: 23/08/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Manually performed limbal relaxing incisions vs femtosecond laser-guided astigmatic keratotomy
Official scientific title Manually performed limbal relaxing incisions vs femtosecond laser-guided astigmatic keratotomy for correction of corneal astigmatism after phacoemulsification
Brief summary describing the background and objectives of the trial Unfortunately, postoperative astigmatism isn¿t an unusual event. In one very large study of a cataract population, corneal astigmatism between 0.75D and 1.50D was present in more than 40% of patients, with higher levels in nearly 20%. The ideal refractive surgical procedure is simple to perform, inexpensive, and applicable to a wide range of ametropias. Astigmatic keratotomy (AK) is one such procedure. Astigmatic keratotomy is used to treat numerous refractive disorders, including congenital astigmatism, residual corneal astigmatism at the time of or following cataract surgery, post-traumatic astigmatism, and astigmatism after corneal transplantation. Within the past few years, much consideration has been given to an evolutionary variant of the procedure, the limbal relaxing incision (LRI). By moving the incision farther to the periphery, cataract surgeons can safely and predictably remediate mild to moderate amounts of regular astigmatism at the time of cataract surgery by performing this incisional technique. Recent technological developments have shifted ophthalmologist's attention from manually created LRIs and astigmatic keratotomy procedures to femtosecond laser-guided procedures. Femtosecond lasers offer superior incisional accuracy and reproducibility coupled with minimal effects on collateral tissues, achieving levels of safety and reproducibility exceeding those of mechanical techniques. A major clinical application of the femtosecond laser is for creating arcuate incisions that have a precise and accurate length, depth, angular position, and optical zone. Aim of the Research:To compare between manually performed limbal relaxing incisions and femtosecond laser-guided astigmatic keratotomy for correction of corneal astigmatism after phacoemulsification.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Corneal astigmatism,Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 17/09/2017
Actual trial start date
Anticipated date of last follow up 17/09/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants)
Recruitment status Not yet 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 Randomised Simple randomisation using a randomisation table from a statistics book Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Manually performed limbal relaxing incisions Once one setting surgical intervention 42 Active-Treatment of Control Group
Experimental Group astigmatic keratotomy once one setting femtosecond laser guided surgical intervention 42
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-patients who have undergo phacoemulsification. 2-Clear cornea. 3-Astigmatism from 1 diopter up to 4 diopters 1-corneal opacity. 2-History of corneal surgery. 3-Thin cornea. 4-Other cause of diminution of vision rather than corneal astigmatism (eg: optic disc atrophy & maculopathy). 5-Astigmatism less than 1 diopter and more than 4 diopters. 21 Year(s) 65 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
No 27/08/2017 ethics committee of Assiut university
Ethics Committee Address
Street address City Postal code Country
Faculty of medicine - Assiut university Assiut 71111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome keratometric reading by corneal Tomography (Pentacam). 1 week 1 month 3 months 6 months
Secondary Outcome Manifest refraction,uncorrected visual acuity and best corrected visual acuity by snellen's chart. 1 week 1 month 3 months 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tiba femto-second laser center El-mohafza st. Assiut 71111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine Assiut university Assiut 71111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Assiut university Assiut 71111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hassan Lotfy Fahmy El-Galaa st Assiut Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ashraf Rashwan ashrafrashwan.83@hotmail.com 00201148331475 El-mhafza st
City Postal code Country Position/Affiliation
Assiut Egypt
Role Name Email Phone Street address
Public Enquiries Hassan Lotfy Hassaniron57@yahoo.com 00201020833002 El-Galaa st
City Postal code Country Position/Affiliation
Assiut Egypt
Role Name Email Phone Street address
Scientific Enquiries Mohamed Shehata Mohamed.shehata.hussien@gmail.com 01151114443 taksem elbetrol st.
City Postal code Country Position/Affiliation
Assiut 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