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Trial registered on ANZCTR
Registration number
ACTRN12613000314729
Ethics application status
Not yet submitted
Date submitted
18/03/2013
Date registered
20/03/2013
Date last updated
12/12/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Subconjunctival dexamethasone in routine cataract surgery
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Scientific title
A study comparing the postoperative outcomes of cataract surgeries with and without the use of subconjunctival dexamethasone
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Secondary ID [1]
282142
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cataract
288645
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Condition category
Condition code
Eye
288983
288983
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0
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Diseases / disorders of the eye
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Surgery
289001
289001
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0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The administration of a single dose (1ml) of subconjunctival dexamethasone (4mg/ml) injection at the end of uncomplicated cataract surgery. We will examine the amount of post-operative intraocular inflammation and macular oedema following surgery for 1 month post-surgery
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Intervention code [1]
286751
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Treatment: Drugs
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Comparator / control treatment
Cataract surgery without the administration of a single dose of subconjunctival dexamethasone.
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Control group
Active
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Outcomes
Primary outcome [1]
289102
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Post-operative ocular inflammation (using slit-lamp examination)
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Assessment method [1]
289102
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Timepoint [1]
289102
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1 month post-operatively
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Primary outcome [2]
289115
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Macular oedema (using optical coherence tomography)
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Assessment method [2]
289115
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Timepoint [2]
289115
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1 month post-operatively
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Secondary outcome [1]
301819
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Level of participant comfort during and following cataract surgery (using a questionnaire with a visual analogue scale)
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Assessment method [1]
301819
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Timepoint [1]
301819
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1 day post-operatively
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Secondary outcome [2]
301847
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Complications of surgery (determined by clinical examination) e.g. retinal detachment, uveitis, endophthalmitis
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Assessment method [2]
301847
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Timepoint [2]
301847
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1 month post-operatively
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Eligibility
Key inclusion criteria
Patients with visually debilitating cataracts requiring surgery
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients with a history of other ocular pathologies or other abnormal ocular examinations
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants in this study will have routine cataract surgery either with or without subconjunctival dexamethasone injection. Whether participants receive an injection of dexamethasone or not will be determined by their surgeon. This study will not determine whether participants receive an injection but will look at the outcomes of surgery.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will not be randomised
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/04/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
240
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
780
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The Alfred - Prahran
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Recruitment postcode(s) [1]
6593
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3181 - Prahran
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Funding & Sponsors
Funding source category [1]
286911
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Hospital
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Name [1]
286911
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The Alfred Hospital
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Address [1]
286911
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PO Box 315
Prahran VIC 3181
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Country [1]
286911
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Australia
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Primary sponsor type
Hospital
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Name
The Alfred
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Address
PO Box 315
Prahran VIC 3181
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Country
Australia
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Secondary sponsor category [1]
285698
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None
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Name [1]
285698
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Address [1]
285698
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Country [1]
285698
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
288969
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The Alfred Research and Ethics Committee
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Ethics committee address [1]
288969
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PO Box 315 Prahran VIC 3181
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Ethics committee country [1]
288969
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Australia
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Date submitted for ethics approval [1]
288969
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20/03/2013
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Approval date [1]
288969
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Ethics approval number [1]
288969
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Summary
Brief summary
For many years, some eye surgeons have given patients having cataract surgery an injection of dexamethasone (a type of cortisone or steroid) into the surface of the eye (subconjunctival) at the end of surgery. Dexamethasone is approved in Australia to treat inflammation of the eye during and following eye surgery. Some surgeons believe the injections are not needed because: 1. The steroid drops are usually enough to help the eye recover 2. The injection can occasionally hurt Others surgeons use the injection because: 1. It seems to makes patients’ eyes more comfortable for the first few days after surgery 2. It may help vision to improve faster after surgery by reducing the risk of macular oedema (swelling of the central part of the retina) This study will not determine whether a patient receives a dexamethasone injection but will look at the outcomes of surgery. From this, we hope to show how useful it is to give a subconjunctival injection of dexamethasone at the time of cataract surgery.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
38566
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Dr Bob Wang
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Address
38566
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The Alfred
PO Box 315
Prahran VIC 3181
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Country
38566
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Australia
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Phone
38566
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+61 3 9076 2000
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Fax
38566
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Email
38566
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bobzwang@gmail.com
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Contact person for public queries
Name
38567
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Bob Wang
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Address
38567
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The Alfred
PO Box 315
Prahran VIC 3181
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Country
38567
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Australia
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Phone
38567
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+61 3 9076 2000
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Fax
38567
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Email
38567
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bobzwang@gmail.com
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Contact person for scientific queries
Name
38568
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Bob Wang
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Address
38568
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The Alfred
PO Box 315
Prahran VIC 3181
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Country
38568
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Australia
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Phone
38568
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+61 3 9076 2000
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Fax
38568
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Email
38568
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bobzwang@gmail.com
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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.
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