Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000553279
Ethics application status
Not yet submitted
Date submitted
16/06/2009
Date registered
8/07/2009
Date last updated
8/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical vs Oral agents to lower intra-ocular pressure following cataract surgery (Acetazolamide vs Brimonidine)
Scientific title
Among patients who undergo phacoemulsification cataract surgery, is a single dose of topical brimonidine as effective, or more effective than a single dose of oral acetazolamide to lower intra-ocular pressure, post-operatively?
Universal Trial Number (UTN)
Trial acronym
TOLIOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elevations of intra-ocular pressure following cataract surgery. 237018 0
Condition category
Condition code
Eye 237341 237341 0 0
Diseases / disorders of the eye
Surgery 237502 237502 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) Brimonidine 0.2%, 1 eye drop immediately post operatively. 2)Oral acetazolamide, single dose 250mg tablet immediately post op.
Intervention code [1] 236761 0
Treatment: Drugs
Comparator / control treatment
Control will be single dose acetazolamide as above, commonly used as standard practice.
Control group
Active

Outcomes
Primary outcome [1] 238159 0
Intra-ocular pressure, using a Goldmann Tonometer
Timepoint [1] 238159 0
Three measurements are taken; 1 week pre-operatively, 3-4 hours post operatively, and 22-24 hours post operatively
Secondary outcome [1] 242442 0
Nil
Timepoint [1] 242442 0
Nil

Eligibility
Key inclusion criteria
Phaco emulsification cataract surgery performed under local anaesthesia
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Glaucoma.
Use of any agent designed to lower intra ocular pressure
Previous ocular surgery on the study eye.
Known allergic reactions to sulphonamides

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study envelopes containing the patient’s allocation to either group A or B will be given to the clinical nurse of the ophthalmology clinic. They will be sequentially numbered, sealed, identical and opaque. These envelopes will be allocated to patients sequentially.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation of study group within these envelopes will be completed at an earlier time by an individual independent to the study. They will utilize a computer randomization program to generate the allocation of each patient (e.g. 1-56) to study arm A or B. They will then insert the appropriate documentation for the administration of agent A or B into each envelope, prior to sealing. There will be equal numbers of envelopes for each group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237154 0
Self funded/Unfunded
Name [1] 237154 0
Jamie Chew
Country [1] 237154 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
NEDLANDS WA 6009
Country
Australia
Secondary sponsor category [1] 4645 0
None
Name [1] 4645 0
Address [1] 4645 0
Country [1] 4645 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239247 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 239247 0
Ethics committee country [1] 239247 0
Date submitted for ethics approval [1] 239247 0
28/04/2009
Approval date [1] 239247 0
Ethics approval number [1] 239247 0

Summary
Brief summary
Tragically, one patient in this state recently suffered a fatal outcome following a severe allergic reaction to acetazolamide, a routine post-operative oral tablet used following cataract surgery to combat increases in the amount of fluid pressure within the operated eye. If not controlled, this increase in pressure can lead to damage to the optic nerve and retinal artery and vein occlusion in susceptible patients. There have been 2 similar cases of severe allergic reactions to acetazolamide reported in the medical literature. A survey of consultants in the United Kingdom found that 83% of surgeons who routinely prescribed pressure lowering medications used acetazolamide.
We propose to investigate the use of brimonidine, a topical agent in a case-control study vs. oral acetazolamide in patients who have undergone phacoemulsification cataract surgery. We hypothesise that this topical agent will have a similar or superior efficacy in controlling ocular hypertension, whilst avoiding potentially serious systemic adverse effects. It is hoped that this may provide the impetus for change in clinical practice, where currently, the majority of patients are prescribed oral acetazolamide. To our knowledge, such a study comparing single dose use of these medications has not been published.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 29744 0
Address 29744 0
Country 29744 0
Phone 29744 0
Fax 29744 0
Email 29744 0
Contact person for public queries
Name 12991 0
Jamie Chew
Address 12991 0
PO Box 1682
WEST PERTH 6872
Country 12991 0
Australia
Phone 12991 0
+61893463333
Fax 12991 0
Email 12991 0
[email protected]
Contact person for scientific queries
Name 3919 0
Jamie Chew
Address 3919 0
PO Box 1682
WEST PERTH 6872
Country 3919 0
Australia
Phone 3919 0
+61893463333
Fax 3919 0
Email 3919 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
No additional documents have been identified.