Condition category
Eye Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
29/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr David F Gilmour

ORCID ID

Contact details

Ophthalmology Department
Beckett Street
Leeds
LS9 7TF
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes