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
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 design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
1. Rate of healing and subsequent recurrence of corneal erosion |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Ophthamology
Reading
RG1 5AN
United Kingdom
RG1 5AN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |