Condition category
Eye Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
18/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Soupramanien Sandramouli

ORCID ID

Contact details

The Wolverhampton & Midland Counties Eye Infirmary
Compton Road
Wolverhampton
WV3 9QR
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes