Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000344897
Ethics application status
Approved
Date submitted
19/03/2012
Date registered
26/03/2012
Date last updated
26/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Intravitreal Steroid for Anterior Ischemic Optic Nerve disease.
Scientific title
The effect of intravitreal triamcinolone on best corrected visual acuity (BCVA) and visual field in patients with non-arteritic anterior ischemic optic neuropathy.
Secondary ID [1] 280168 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-arteritic Anterior Ischemic Optic Neuropathy 286098 0
Condition category
Condition code
Eye 286291 286291 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An intravitreal injection of 4 mg/0.1ml triamcinolone acetonide
Intervention code [1] 284497 0
Treatment: Drugs
Comparator / control treatment
observation with standard care
Control group
Active

Outcomes
Primary outcome [1] 286761 0
BCVA) according to the Snellen chart (converted to logMAR units) at twelfth week
Timepoint [1] 286761 0
twelfth week
Primary outcome [2] 286762 0
Mean deviation of automated perimetry 30-2 on a Humphrey field analyzer
Timepoint [2] 286762 0
twelfth week
Secondary outcome [1] 296603 0
Retinal nerve fiber layer thickness using Optical Coherence Tomography (OCT)
Timepoint [1] 296603 0
twelfth week

Eligibility
Key inclusion criteria
- acute painless visual loss
- localized optic disc edema
- no associated symptoms (; i.e. headache/scalp tenderness/jaw claudication)
- unilateral involvement with the normal fellow eye
- no previous attack or treatment
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- ocular and/or orbital infection
- other ocular disease that might interfere with visual acuity and/ or the visual field

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
- All of the patients were randomized into two groups: one treated with IVTA while the other was simply observed.
- allocation concealment by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 4208 0
Thailand
State/province [1] 4208 0
Khon Kaen

Funding & Sponsors
Funding source category [1] 284917 0
University
Name [1] 284917 0
Khon Kaen University
Country [1] 284917 0
Thailand
Primary sponsor type
University
Name
Khon Kaen University
Address
Faculty of Medicine, Khon Kaen University, Mitraparp Road, Muang, Khon Kaen, Thailand 40002
Country
Thailand
Secondary sponsor category [1] 283792 0
None
Name [1] 283792 0
Address [1] 283792 0
Country [1] 283792 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286917 0
Human Ethic Commitee of Khon Kaen University
Ethics committee address [1] 286917 0
Faculty of Medicine, Khon Kaen University, Mitraparp Road, Muang, Khon Kaen, Thailand 40002
Ethics committee country [1] 286917 0
Thailand
Date submitted for ethics approval [1] 286917 0
Approval date [1] 286917 0
Ethics approval number [1] 286917 0

Summary
Brief summary
The purpose of this study was to determine the effect of intravitreal triamcinolone acetonide (IVTA), compared to careful observation, in restoration of optic nerve functions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33941 0
Address 33941 0
Country 33941 0
Phone 33941 0
Fax 33941 0
Email 33941 0
Contact person for public queries
Name 17188 0
Kitthisak Kitthaweesin
Address 17188 0
Department of Ophthalmology
Faculty of Medicine, Khon Kaen University, Mitraparp Road, Muang, Khon Kaen, Thailand 40002
Country 17188 0
Thailand
Phone 17188 0
6643348383
Fax 17188 0
6643348383
Email 17188 0
kitthisak@hotmail.com
Contact person for scientific queries
Name 8116 0
Kitthisak Kitthaweesin
Address 8116 0
Department of Ophthalmology
Faculty of Medicine
Khon Kaen University
Khon KaeFaculty of Medicine, Khon Kaen University, Mitraparp Road, Muang, Khon Kaen, Thailand 40002
Country 8116 0
Thailand
Phone 8116 0
6643348383
Fax 8116 0
6643348383
Email 8116 0
kitthisak@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.