Effect of intralesional triamcinolone acetonide injection (TA) in comparison with incision and curettage (I and C) on treatment of patients with chronic chalazion
In this study, effect of intralesional triamcinolone acetonide injection (TA) in comparison with incision and curettage (I and C) on treatment of chronic chalazion was investigated. In this randomized controlled trial, 51 patients with chronic chalazion who admitted to the Nikookary eye center were randomly allocated into two groups to receive an intralesional injection of TA (n=26) or I and C (n=25). All patients with chronic chalazion that unresponsive to medical treatment were included and patients with atypical chalazia, multiple chalazia on one eyelid, concurrent eyelid infection, and history of previous treatment by TA or I and C were excluded from the study. Patients were followed up for minimum of 45 days. Ninety percent regression in size of lesion was determined as success in treatment of patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606156033N5
Registration date:2016-12-21, 1395/10/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-21, 1395/10/01
Registrant information
Name
Reza Nabie
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 411365577236
Email address
nabier@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-07-01, 1392/04/10
Expected recruitment end date
2015-07-01, 1394/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intralesional triamcinolone acetonide injection (TA) in comparison with incision and curettage (I and C) on treatment of patients with chronic chalazion
Public title
Comparison of intralesional triamcinolone acetonide injection (TA) and curretage on treatment of chalazion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients with chronic chalazion which unresponsive to medical treatment.
Exclusion criteria: patients with chalazia which have atypical features, concurrent eyelid infection, multiple chalazia on one eyelid, history of previous treatment by TA or I and C
Age
From 13 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University Of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2013-05-06, 1392/02/16
Ethics committee reference number
9395
Health conditions studied
1
Description of health condition studied
Diseases of the eye and adnexa
ICD-10 code
H00.1
ICD-10 code description
Chalazion
Primary outcomes
1
Description
Decreased size of chalazion
Timepoint
45 days
Method of measurement
Size of chalazion was measured by ruller and 90% decrease in the size of chalazion was defined as success
Secondary outcomes
1
Description
Recurrence of chalazion
Timepoint
45 days
Method of measurement
Observation
Intervention groups
1
Description
Intervention: Triamcinolone Acetate injection into the lesion