Evaluation of Lacrimal Stent (mini monoka) for treatment of punctal stenosis: a prospective randomised comparative study

ISRCTN ISRCTN10637745
DOI https://doi.org/10.1186/ISRCTN10637745
Secondary identifying numbers N0214126228
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
18/10/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Soupramanien Sandramouli
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvaluation of Lacrimal Stent (mini monoka) for treatment of punctal stenosis: a prospective randomised comparative study
Study objectivesWhat is the use of lacrimal stent to relieve clinically significant Epiphora caused by punctal stenosis.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedEye Diseases: Epiphora
InterventionRandomised comparative study of single snip procedure vs mini monoka (monocanalicular lacrimal stent)
Intervention typeOther
Primary outcome measure1. Decrease in epiphora
1.1. subjectively using the questionnaire
1.2. objectively using fluoroscene dye disappearance test
Secondary outcome measuresNot provided at time of registration
Overall study start date30/05/2003
Completion date30/09/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants40
Key inclusion criteria40 patients with punctal stenosis
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment30/05/2003
Date of final enrolment30/09/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Hospital/treatment centre

The Royal Wolverhampton Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

18/10/2017: No publications found, study status unverified