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 |
| Secondary identifying numbers | N0436186550 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 22/06/2006 |
| Completion date | 01/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
Ophthalmology Department
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Leeds Teaching Hospitals NHS Trust
No information available
NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
