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.: PACTR201907757137778 Date of Approval: 11/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Peribulbar anesthesia with adrenaline versus without adrenaline on retinal thickness in patients undergoing elective cataract surgery
Official scientific title Effect of Peribulbar anesthesia with adrenaline versus without adrenaline on retinal thickness
Brief summary describing the background and objectives of the trial Background: The toxic effect of local anesthetia on retinal integrity was previously investigated in animal studies but not in human. Aim of the work: To study the effect of local anaesthesia with lidocaine, versus local anaesthesia with lidocaine with exta administration of adrenaline, on retinal layers thickness measured by Optical coherence tomography (ОСТ) in patients undergoing elective cataract surgery.
Type of trial RCT
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 Early detection /Screening
Anticipated trial start date 02/06/2018
Actual trial start date 02/06/2018
Anticipated date of last follow up 01/01/2019
Actual Last follow-up date 01/01/2019
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group local anaethesia local anaesthesia with lidocaine 2% with extra administration of adrenaline preoperative Local anaesthesia with lidocaine 2% with extra administration of adrenaline 30
Control Group Local anaesthesia local anaesthesia with lidocaine 2% preoperative local anaesthesia with lidocaine 2% only 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients candidate for elective cataract surgery by phacoemulsification. 1. Patients with a history of hypertension or ischemic heart disease. 2. Patients with any coexisting ocular conditions such as nystagmus, ptosis, ocular movement abnormality, reduced corneal sensation, or facial nerve palsy 3. Patients with allergy to local anaesthetics 4. If the patient refused the local anaesthesia technique 5. Inability to understand the information about the study Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 70 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 09/12/2018 Research Ethical Committee of Beni suef University
Ethics Committee Address
Street address City Postal code Country
Salah Salem street Beni Suef 62511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Changes in retinal thickness one week post operative
Secondary Outcome optic nerve head vascularity one week post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni Suef university Salah Salem street Beni suef 62511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded Salah Salem Street Beni Suef 62511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Beni suef university Salah Salem street Beni suef 62511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Wael fathy Salah Salem street Beni Suef 62511 Egypt
Ahmed Taha Salah Salem street Beni suef 62511 Egypt
Sahar Ibrahim Salah Salem street Beni Suef 62511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wael Fathy drwaelfathy@yahoo.com +201006527133 Salah Salem street
City Postal code Country Position/Affiliation
Beni suef 62511 Egypt Lecturer of Anaesthesia
Role Name Email Phone Street address
Public Enquiries Ahmed Taha Ahmed_oph79@yahoo.com +201153213176 Salah Salem street
City Postal code Country Position/Affiliation
Beni suef 62511 Egypt Lecturer of ophthalmology
Role Name Email Phone Street address
Scientific Enquiries Sahar Ibrahim Sahar_oph79@yahoo.com +201114123192 Salah Salem street
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt Lecturer of ophthalmology
Role Name Email Phone Street address
Scientific Enquiries Mona Husssein mona.neuro@yahoo.com +201005131318 Salah Salem street
City Postal code Country Position/Affiliation
Beni suef 62511 Egypt Lecturer of neurology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Demographics of the patients Results of OCT for included patients pre and postoperative Informed Consent Form,Study Protocol one year after publication controlled access Demographics of the patients and Results of OCT for included patients pre and postoperative are allowed. Data will be requested by contacting the corresponding author The request will be revised by principle investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Regarding OCT findings in patients in Adrenaline group, there was a statistically significant postoperative decrease in superior (P-value=0.028), inferior (P-value=0.017), or average retinal thickness (P-value=0.021). In control group, there was also a statistically significant postoperative decrease in superior (P-value=0.032), inferior (P-value=0.046), or average retinal thickness (P-value=0.028). On comparing OCT findings in adrenaline and control group, there was no statistically significant difference between groups regarding the decrease in superior (P-value=0.325), inferior (P-value=0.642), or average retinal thickness (P-value=0.291) 04/05/2019 15/05/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://drive.google.com/open?id=1iSL70hZ_Gd-qhAXi9vfA8UDHALy_H8YE
Changes to trial information