Lateral tarsal strip and everting sutures vs lateral tarsal strip and Jones procedure for involutional entropion: 2 year prospective randomized controlled trial
| ISRCTN | ISRCTN29030032 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29030032 |
| Protocol serial number | N0436186550 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | Leeds Teaching Hospitals NHS Trust, NHS R&D Support Funding |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 29/08/2012
- 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 David F Gilmour
Scientific
Scientific
Ophthalmology Department
Beckett Street
Leeds
LS9 7TF
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | This trial will compare two methods of surgically correcting age-related in-turning of the eyelid (involutional entropion) and address the following: which is the commonest malposition of the eyelid seen in our practice? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Eye Diseases: Involutional entropion |
| Intervention | Questionnaire. Lateral tarsal strip and everting sutures compared to lateral tarsal strip and Jones procedure. |
| Intervention type | Other |
| Primary outcome measure(s) |
The functional (absence of symptoms) cosmetic (patient satisfaction with appearance) and anatomical ( as assessed by surgeon) success of the procedure at final follow up visit. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Key inclusion criteria | 1. Patients older than 60 years of age with primary involutional lower lid entropion 2. Patients suitable for local anaesthetic 3. Patients able to consent for the procedure |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 22/06/2006 |
| Date of final enrolment | 01/03/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Ophthalmology Department
Leeds
LS9 7TF
United Kingdom
LS9 7TF
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 |
