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
Protocol serial number N0214126228
Sponsor Department of Health
Funder The Royal Wolverhampton Hospitals NHS Trust (UK)
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

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant 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 measure(s)

1. Decrease in epiphora
1.1. subjectively using the questionnaire
1.2. objectively using fluoroscene dye disappearance test

Key secondary outcome measure(s)

Not provided at time of registration

Completion date30/09/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration40
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

  • United Kingdom
  • England

Study participating centre

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

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

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