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.: PACTR201608001739424 Date of Approval: 09/08/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Combined subconjunctival Atropine and intracameral epinephrine for pupil dilation in phacoemulsification .A comparative study .
Official scientific title Combined subconjunctival Atropine and intracameral epinephrine for pupil dilation in phacoemulsification .A comparative study .
Brief summary describing the background and objectives of the trial Sufficient pupil dilation is mandatory for safe cataract extraction surgery .Conventional topical drugs have numerous drawbacks .In order to overcome these drawbacks , a new approach is suggested .Our study aims at evaluating the safety and efficacy of this new approach .
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied cataract,Eye Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 14/08/2016
Actual trial start date 14/08/2016
Anticipated date of last follow up 16/10/2016
Actual Last follow-up date 16/10/2016
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Recruiting
Publication URL Ashraf Nossair Mydriatics
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group topical tropicamide and phenylephrine for pupil dilation in phacoemulsification every 15 minutes for one hour before surgery one hour before surgery topical tropicamide and phenylephrine every 15 minutes for one hour for pupil dilation before cataract extraction surgery (phacoemulsification) 20 Active-Treatment of Control Group
Experimental Group Injection group Single Subconjunctival 0.6mg atropine and single intracameral 1:100000 epinephrine injection Single Subconjunctival atropine at the time of peri bulbar local anesthesia injection 10 minutes before corneal incisions and injection of 0.3 to 0.4 ml of 1:100000 epinephrine intracameral Combined single Subconjunctival atropine and intracameral epinephrine 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Cases of bilateral visually significant cataract Poor pupil dilation , traumatic cataract , uveitic cataract , glaucoma patients ,optic nerve diseases and the use of systemic or topical mydriatics or miotics 30 Year(s) 80 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 08/08/2016 Research ethical committee of Dar El Oyoun hospital
Ethics Committee Address
Street address City Postal code Country
9 th Ghazali street , El Dokki Cairo 12311 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome dilated pupil size 1-just before corneal incisions 2-after injection of viscoelastic 3-just after wound hydration
Secondary Outcome Effective Phaco time , systemic intraoperative complications , ocular intraoperative complications , postoperative visual acuity , intraocular pressure , pupil size and postoperative complications 1-intraoperative : effective Phaco time , blood pressure and heart rate or any intraocular intraoperative complications. 2-postoperative after 1 day and 1 week : visual acuity , pupil size , intraocular pressure and postoperative complications.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dar El Oyoun hospital 9 th GHazali street , el dokki Cairo 12311 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dar El Oyoun hospital 9 th GHazali street , el dokki Cairo 12311 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dar El Oyoun hospital 9 th GHazali street , el dokki Cairo 12311 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Wael Ahmed Ewais 24 Shehab street ,El mohandeseen Cairo 11411 Egypt
Lamia Samy Aly 152 beverly hills , october Cairo 12566 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ashraf Nossair ashrafnossair@yahoo.com +201223480325 28 misr helwan street , Maadi
City Postal code Country Position/Affiliation
cairo 11728 Egypt
Role Name Email Phone Street address
Public Enquiries Ola Abdul hamid olaabdelhamid@dareloyoun.org +201006341625 9 th Ghazali street ,Dokki
City Postal code Country Position/Affiliation
cairo 12311 Egypt Research ethical committee executaive
Role Name Email Phone Street address
Scientific Enquiries Khaled Samir khsamir@hotmail.com +201221022512 9 th Ghazali street ,Dokki
City Postal code Country Position/Affiliation
cairo 12311 Egypt Research ethical committee chairman
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