Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436186550
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Eye Diseases: Involutional entropion
Intervention
Questionnaire. Lateral tarsal strip and everting sutures compared to lateral tarsal strip and Jones procedure.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
22/06/2006
Overall trial end date
01/03/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
22/06/2006
Recruitment end date
01/03/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Ophthalmology Department
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Leeds Teaching Hospitals NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary