Randomised controlled study of Lubrication with and without Bandage Contact Lens in primary treatment of Recurrent Corneal Erosion Syndrome

ISRCTN	ISRCTN22866928
DOI	https://doi.org/10.1186/ISRCTN22866928
Secondary identifying numbers	N0199166145

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Maghizh Anandan
Scientific

Department of Ophthamology
Eye Block
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom

Phone	+44 0118 322 8150

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	08/08/2005
Completion date	30/06/2008

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	40
Key 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
Key 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
Date of first enrolment	08/08/2005
Date of final enrolment	30/06/2008

Department of Ophthamology

Reading
RG1 5AN
United Kingdom

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Royal Berkshire and Battle Hospitals NHS Trust

No information available

NHS R&D Support Funding

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2011		Yes	No