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
Protocol serial number N0199166145
Sponsor Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders Royal Berkshire and Battle Hospitals NHS Trust, NHS R&D Support Funding
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
18/04/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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 information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific title
Study objectivesTo 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) studiedEye Diseases: Recurrent corneal erosion syndrome
InterventionProspective, 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 typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

Not provided at time of registration

Completion date30/06/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration40
Key inclusion criteriaAll 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 criteria1. 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 enrolment08/08/2005
Date of final enrolment30/06/2008

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Department of Ophthamology
Reading
RG1 5AN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2011 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes