Condition category
Eye Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
18/04/2012
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 Maghizh Anandan

ORCID ID

Contact details

Department of Ophthamology
Eye Block
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom
+44 0118 322 8150

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0199166145

Study information

Scientific title

Acronym

Study hypothesis

To compare lubrication alone as a treatment of recurrent corneal erosion against bandage contact lenses with lubrication on the rate of healing and subsequent recurrence of corneal ersion.

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

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Eye Diseases: Recurrent corneal erosion syndrome

Intervention

Prospective, randomised controlled trial comparing lubrication alone as a treatment of recurrent corneal erosion against bandage contact lenses with lubrication on the rate of healing and subsequent recurrence of corneal erosions. Target 20 patients per group.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Rate of healing and subsequent recurrence of corneal erosion
2. Symptom control
3. Incidence of adverse outcomes, particularly corneal infection

Secondary outcome measures

Not provided at time of registration

Overall trial start date

08/08/2005

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

All patients diagnosed with Recurrent Corneal Erosion Syndrome (RCES) seen in eye casualty on the basis of spontaneously recurring focal epithelial defect of epithelial defect diagnosed for the first time with characteristic symptoms of RCE

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

1. RCE with evidence of infection, as the management will differ due to infection
2. Patients with any other corneal pathology and those who have had surgical treatments for RCE in the past as they may affect the outcome of the study

Recruitment start date

08/08/2005

Recruitment end date

30/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Ophthamology
Reading
RG1 5AN
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 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

Royal Berkshire and Battle 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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21316295

Publication citations

  1. Results

    Moutray TN, Frazer DG, Jackson AJ, Recurrent erosion syndrome--the patient's perspective., Cont Lens Anterior Eye, 2011, 34, 3, 139-143, doi: 10.1016/j.clae.2010.11.006.

Additional files

Editorial Notes