Contact information
Type
Scientific
Primary contact
Miss Amynah Goawalla
ORCID ID
Contact details
Department of Ophthalmology
North West London Hospitals NHS Trust
Central Middlesex Hospital
Acton Lane
Park Royal
London
NW10 7NS
United Kingdom
+44 (0)20 8963 7158
amynahgoawalla@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0515174066
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Whether or not complete resolution of the chalazion is achieved at three weeks as a result of the treatment.
Secondary outcome measures
Degree of pain endured by patients, patients' level of satisfaction, any adverse events and the overall level of inconvenience.
Overall trial start date
01/06/2005
Overall trial end date
30/11/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with a palpable chalazion or multiple chalaxia
2. Patients over 18 years old
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
125
Participant 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
Recruitment start date
01/06/2005
Recruitment end date
30/11/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Ophthalmology
London
NW10 7NS
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North West London Hospitals NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17997772
Publication citations
-
Results
Goawalla A, Lee V, A prospective randomized treatment study comparing three treatment options for chalazia: triamcinolone acetonide injections, incision and curettage and treatment with hot compresses., Clin. Experiment. Ophthalmol., 2007, 35, 8, 706-712, doi: 10.1111/j.1442-9071.2007.01617.x.