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
Scientific
The Wolverhampton & Midland Counties Eye Infirmary
Compton Road
Wolverhampton
WV3 9QR
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Evaluation of Lacrimal Stent (mini monoka) for treatment of punctal stenosis: a prospective randomised comparative study |
| Study objectives | What 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) studied | Eye Diseases: Epiphora |
| Intervention | Randomised comparative study of single snip procedure vs mini monoka (monocanalicular lacrimal stent) |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Decrease in epiphora |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Key inclusion criteria | 40 patients with punctal stenosis |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 30/05/2003 |
| Date of final enrolment | 30/09/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Wolverhampton & Midland Counties Eye Infirmary
Wolverhampton Road
Wolverhampton
WV3 9QR
United Kingdom
Wolverhampton
WV3 9QR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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