Conservative vs surgical treatment of eyelid chalazia
| ISRCTN | ISRCTN67736644 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67736644 |
| Protocol serial number | N0515174066 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | North West London Hospitals NHS Trust |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 09/12/2010
- 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
Miss Amynah Goawalla
Scientific
Scientific
Department of Ophthalmology
North West London Hospitals NHS Trust
Central Middlesex Hospital
Acton Lane, Park Royal
London
NW10 7NS
United Kingdom
| Phone | +44 (0)20 8963 7158 |
|---|---|
| amynahgoawalla@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To identify which out of 3 options currently available for the management of eye lid cyst (chalazia) is the most effective one: 1. Surgical drainage of the cyst under local anaesthetic 2. Steroid injection into the cyst 3. No treatment |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Eye Diseases: Eyelid chalazia |
| Intervention | Surgical drainage of the cyst under local anaesthetic vs steroid injection into the cyst vs no treatment |
| Intervention type | Other |
| Primary outcome measure(s) |
Whether or not complete resolution of the chalazion is achieved at three weeks as a result of the treatment. |
| Key secondary outcome measure(s) |
Degree of pain endured by patients, patients' level of satisfaction, any adverse events and the overall level of inconvenience. |
| Completion date | 30/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 125 |
| Key inclusion criteria | 1. Patients with a palpable chalazion or multiple chalaxia 2. Patients over 18 years old |
| Key exclusion criteria | 1. Patients with chalazia with atypical appearance 2. Patients allergic to any treatment 3. Patients under 18 years old 4. Patients without a palpable lid cyst or a concurrent eyelid infection |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 30/11/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Ophthalmology
London
NW10 7NS
United Kingdom
NW10 7NS
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 | 01/11/2007 | Yes | No |