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

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
Email amynahgoawalla@gmail.com

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesTo 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) studiedEye Diseases: Eyelid chalazia
InterventionSurgical drainage of the cyst under local anaesthetic vs steroid injection into the cyst vs no treatment
Intervention typeOther
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 date30/11/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target sample size at registration125
Key inclusion criteria1. Patients with a palpable chalazion or multiple chalaxia
2. Patients over 18 years old
Key exclusion criteria1. 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 enrolment01/06/2005
Date of final enrolment30/11/2007

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Department of Ophthalmology
London
NW10 7NS
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 01/11/2007 Yes No