Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0214126228
Study information
Scientific title
Evaluation of Lacrimal Stent (mini monoka) for treatment of punctal stenosis: a prospective randomised comparative study
Acronym
Study hypothesis
What is the use of lacrimal stent to relieve clinically significant Epiphora caused by punctal stenosis.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Eye Diseases: Epiphora
Intervention
Randomised comparative study of single snip procedure vs mini monoka (monocanalicular lacrimal stent)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Decrease in epiphora
1.1. subjectively using the questionnaire
1.2. objectively using fluoroscene dye disappearance test
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/05/2003
Overall trial end date
30/09/2005
Reason abandoned
Eligibility
Participant inclusion criteria
40 patients with punctal stenosis
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
40
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
30/05/2003
Recruitment end date
30/09/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Wolverhampton & Midland Counties Eye Infirmary
Wolverhampton Road
Wolverhampton
WV3 9QR
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Royal Wolverhampton Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary