Condition category
Eye Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
09/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17997772

Publication citations

  1. 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.

Additional files

Editorial Notes