Trial Review

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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
Scientific title
A study comparing the postoperative outcomes of cataract surgeries with and without the use of subconjunctival dexamethasone
Secondary ID [1] 282142 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 288645 0
Condition category
Condition code
Eye 288983 288983 0 0
Diseases / disorders of the eye
Surgery 289001 289001 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 286751 0
Treatment: Drugs
Comparator / control treatment
Cataract surgery without the administration of a single dose of subconjunctival dexamethasone.
Control group
Active

Outcomes
Primary outcome [1] 289102 0
Post-operative ocular inflammation (using slit-lamp examination)
Timepoint [1] 289102 0
1 month post-operatively
Primary outcome [2] 289115 0
Macular oedema (using optical coherence tomography)
Timepoint [2] 289115 0
1 month post-operatively
Secondary outcome [1] 301819 0
Level of participant comfort during and following cataract surgery (using a questionnaire with a visual analogue scale)
Timepoint [1] 301819 0
1 day post-operatively
Secondary outcome [2] 301847 0
Complications of surgery (determined by clinical examination) e.g. retinal detachment, uveitis, endophthalmitis
Timepoint [2] 301847 0
1 month post-operatively

Eligibility
Key inclusion criteria
Patients with visually debilitating cataracts requiring surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of other ocular pathologies or other abnormal ocular examinations

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will not be randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 780 0
The Alfred - Prahran
Recruitment postcode(s) [1] 6593 0
3181 - Prahran

Funding & Sponsors
Funding source category [1] 286911 0
Hospital
Name [1] 286911 0
The Alfred Hospital
Country [1] 286911 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
PO Box 315
Prahran VIC 3181
Country
Australia
Secondary sponsor category [1] 285698 0
None
Name [1] 285698 0
Address [1] 285698 0
Country [1] 285698 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288969 0
The Alfred Research and Ethics Committee
Ethics committee address [1] 288969 0
PO Box 315
Prahran VIC 3181
Ethics committee country [1] 288969 0
Australia
Date submitted for ethics approval [1] 288969 0
20/03/2013
Approval date [1] 288969 0
Ethics approval number [1] 288969 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38566 0
Dr Bob Wang
Address 38566 0
The Alfred
PO Box 315
Prahran VIC 3181
Country 38566 0
Australia
Phone 38566 0
+61 3 9076 2000
Fax 38566 0
Email 38566 0
[email protected]
Contact person for public queries
Name 38567 0
Dr Bob Wang
Address 38567 0
The Alfred
PO Box 315
Prahran VIC 3181
Country 38567 0
Australia
Phone 38567 0
+61 3 9076 2000
Fax 38567 0
Email 38567 0
[email protected]
Contact person for scientific queries
Name 38568 0
Dr Bob Wang
Address 38568 0
The Alfred
PO Box 315
Prahran VIC 3181
Country 38568 0
Australia
Phone 38568 0
+61 3 9076 2000
Fax 38568 0
Email 38568 0
[email protected]

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
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