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.: PACTR201901856970887 Date of Approval: 15/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title OCT imaging of the punctum before and after phacoemulsification.
Official scientific title Evaluation of the lacrimal punctum after uncomplicated Phacoemulsification Using Anterior Segment OCT.
Brief summary describing the background and objectives of the trial Some previous studies have shown alterations in lacrimal physiology after cataract surgery. In our practice, we encounter increasing rates of epiphora after uneventful phacoemulsification with no clear explanation can yet be provided. In this study, we report the application of spectral-domain AS- OCT for in vivo assessment of the lacrimal puncta of patients undergoing phacoemulsification. Purpose, To study features of the lacrimal punctum in patients undergoing unilateral phacoemulsification using spectral domain anterior segment optical coherence tomography (SD AS-OCT) compared to the contralateral side.
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 Early detection /Screening
Anticipated trial start date 01/02/2019
Actual trial start date
Anticipated date of last follow up 01/01/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
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 Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Phacoemulsification for senile cataract 6 months follow up All patients will undergo; Tear meniscus height measurement Dye disappearance test Canalicaulr probing Punctual photographs OCT of the punctum. 50
Control Group Nonoperated 6 months follow up All patients will undergo Tear meniscus height Dye disappearance test Canalicaulr probing Punctual photographs OCT of the punctum. 50 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
50 patients listed for phacoemulsification Complicated phacoemulsification Previous Phacoemulsification in contralateral side Epiphora Blepharitis Middle Aged: 45 Year(s)-64 Year(s) 45 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
No 01/01/2019 Fayoum University Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Kiman Fares Al Fayoum 63521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Measurements of puncta from OCT images before and after phacoemulsification compared to the contralateral non-operated side. 1 week, 1 month, 3 months, and 6 months
Secondary Outcome Clinical profile of the punctal region, Epiphora 1 week, 1 month, 3 months, and 6 months.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fayoum University Hospital Kiman Fares Fayoum Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mostafa Diab 10 George Nirose St, Al Mesalla Al Fayoum Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fayoum university Hospital Kiman Fares Al Fayoum Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mahrous Shaheen Kofor El Nile Al Fayoum Egypt
Omar Said Yakken Eye Centre Al Fayoum Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Diab mmd11@fayoum.edu.eg +201091168842 10 George Nirose st, Al Mesalla
City Postal code Country Position/Affiliation
Al Fayoum Egypt Associate Professor Of Ophthalmology at Fayoum University Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Mostafa Diab mmd11@fayoum.edu.eg +201091168842 10 George nirose st, Al Mesalla
City Postal code Country Position/Affiliation
Al Fayoum Egypt Associate Professor Of Ophthalmology at Fayoum university Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Mahrous Shaheen Mha13@fayoum.edu.eg +201009477490 Kfour Nile village, Beside International Fayoum Hospital
City Postal code Country Position/Affiliation
Al fayoum Egypt Associate Professor Of Ophthalmology Fayoum University Faculty of Medicine
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