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.: PACTR202105834743189 Date of Approval: 31/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of lacrimal punctal changes by Anterior Segment Optical Coherence Tomography AS-OCT after punctal dilatation versus punctal plug insertion in cases of inflammatory punctal stenosis
Official scientific title Evaluation of lacrimal punctal changes by Anterior Segment Optical Coherence Tomography AS-OCT after punctal dilatation versus punctal plug insertion in cases of inflammatory punctal stenosis
Brief summary describing the background and objectives of the trial Punctal stenosis is an important etiological factor that should be considered when assessing patients with epiphora. Anatomically, acquired punctal stenosis is a condition in which the external opening of the lacrimal canaliculus is narrowed or occluded and also can be accompanied by canalicular ductal stenosis.1,2. Defining an anatomical clear cut-off value for punctal stenosis is difficult due to wide variations in patients’ demographics. Clinically, punctal stenosis is defined as a punctum size restricting tear drainage in the absence of distal tear drainage abnormalities.2 Acquired punctal stenosis can be involutional, inflammatory, infectious or idiopathic.3,4 Inflammatory endogenous causes include chronic blepharitis, dry eye disease and ocular cicatricial pemphigoid.3 Exogenous noxious stimuli may be chemical such as topical or systemic medications, or physical as irradiation or mechanical. The harmful effect of topical medications such as antiglaucomatous drops, dexamesathone, mitomycin-C and the systemic medications such 5-Fluorouracil or paclitaxel may be related to the medication themselves, the preservatives as benzalkonium chloride in the commercial preparations, or duration of treatment with those medications.3,5-9 The basic ultra-structure response to those various noxious stimuli is early punctal occlusion by edema which is followed by conjunctival overgrowth, keratinization of punctal walls and cicatricial punctal stenosis. Although spectral-domain OCT is still being widely used on the retina, its anterior segment module is considered a new modality for imaging of proximal lacrimal excretory passage and tears meniscus height (TMH). Recent studies showed the ability of using AS-OCT to differentiate between various punctal causes of epiphora and improve the understanding of the lacrimal punctal structure in vivo.10–12 The aim of this work is to evaluate the role of AS-OCT in evaluation punctal changes after punctal dilataion and after insertion of punctal plug
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 Treatment: Other
Anticipated trial start date 20/10/2020
Actual trial start date 20/10/2020
Anticipated date of last follow up 20/05/2021
Actual Last follow-up date 20/05/2021
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group punctal dilatation once punctal dilatation in inflamatory punctal stenosis 10 Active-Treatment of Control Group
Experimental Group plug insertion once fore ever punctal plug insertion in case of inflammatory punctal stenosis 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients with inflammatory punctal stenosis patients with other causes of punctal stenosis Patients under 18 years old 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 12/10/2020 faculty of medicine sohag university medical research ethics committee
Ethics Committee Address
Street address City Postal code Country
sohag university sohag 82524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome punctal dilatation 6 months
Secondary Outcome sustained punctal dilatation 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
sohag faculty of medicine sohag university sohag university sohag Egypt sohag 82524 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
sohag university algomhoriya sohag 82524 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sohag university sohag university sohag 82524 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hany Mahmoud drhanymahmoud@gmail.com +201024368111 sohag university
City Postal code Country Position/Affiliation
sohag 82524 Egypt lecturer of ophthalmology sohag university
Role Name Email Phone Street address
Public Enquiries Hany Mahmoud drhanymahmoud@gmail.com +201024368111 sohag university
City Postal code Country Position/Affiliation
sohag 82524 Egypt lecturer sohag university
Role Name Email Phone Street address
Scientific Enquiries Hany Mahmoud drhanymahmoud@gmail.com +201024368111 sohag university
City Postal code Country Position/Affiliation
sohag 82524 Egypt lecturer sohag university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Study Protocol immediatly and no end time punctal stenosis
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