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Trial registered on ANZCTR


Registration number
ACTRN12609000871246
Ethics application status
Approved
Date submitted
14/05/2009
Date registered
7/10/2009
Date last updated
8/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of 2 comercially available Toric intraocular lenses in cataract surgery
Scientific title
Comparison of Zeiss and Rayner comercially available Toric intraocular lens implant stability and visual outcomes with standard cataract surgery
Secondary ID [1] 844 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
concomitant cataract and corneal based astigmatism 4629 0
Condition category
Condition code
Eye 4928 4928 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standard cataract surgery was performed through a 2.75mm temporal section with 2 limbal based parancentsis at ninety degrees to the main section. The cataract was removed utilising an intact continuous curvilinear capsulorexhsis and phacemulusification of the lens and a divide and conquer technique. The toric intraocular lens implant (TIOL) (eithe Zeiss or Rayner) was inserted to correct the defocus from the cataractous lens extraction and dialed into the correct orientation to neutralise the corneal based astigmatsm. The procedure takes about 40 minutes.
Intervention code [1] 4388 0
Treatment: Devices
Comparator / control treatment
The alternate toric intraocular lens implant (TIOL) (Rayner or Zeiss) was used in the second eye of the study. Standard cataract surgery was performed through a 2.75mm temporal section with 2 limbal based parancentsis at ninety degrees to the main section. The cataract was removed utilising an intact continuous curvilinear capsulorexhsis and phacemulusification of the lens and a divide and conquer technique. The TIOL was inserted to correct the defocus from the cataractous lens extraction and dialed into the correct orientation to neutralise the corneal based astigmatsm. The procedure takes about 40 minutes.

The second eye eye is operated on bewteen 1 and 6 months after the first operation.
Control group
Active

Outcomes
Primary outcome [1] 5776 0
Rotational stability of toric IOL as assessed by aligning slit lamp light slit with IOL axis marking on slit lamp graticule in notes.
Timepoint [1] 5776 0
Preoperative, Day 0, Week 1 month 1,6 and 12 following each operation
Secondary outcome [1] 241739 0
Visual acuity (Distance and near)
National Eye Institute Visual functioning questionaire (NEI VFQ 25)
Timepoint [1] 241739 0
Preoperative, Day 0, week 1, month 1, 6 and 12 following each operation

Eligibility
Key inclusion criteria
Bilateral cataracts at trial entry
Age >18
No ocular co-morbidityPatients listed for cataract surgery.
The median corneal based astigmatism value of 3 IOL master based readings with less than 1.0 dioptre variation in astigmatism
An intact continuous curvilinear capsulorehxsis (CCC) at surgery
Minimum age
18 Years
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The existence of other corneal disease or scarring
Failure to achieve repeatable keratometry. Specically a difference of >1.0D astigmatism over 3 readings
Phacodonesis noted preoperatively
The presence of zonnular dehiscence or capsular bag disruption noted at surgery.

Paitents not willing to attend for follow up for the duration of the study.

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)
The research assistant will provide the randomisation but will not know the patient. The operating surgeon will implant the first eye of the patient as per the research assistants instruction. The first eye will be randomised to one of two toric IOLs. The other eye will have the alternate IOL inserted in due course. The patient will be aware thay have one of two toric IOLs but they will not be told which is which. Lens stickers typically placed in the notes will be replaced with a study number. Only on completeion of follow up will the patient be informed and IOL info inserted.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation based on corneal astigmatism <1.5D, <2.5D, <3.5 D and >3.5D. Randomisation occuring as per randomisation tables from the Mater Research support center website http://www.materresearch.org/mrsc/Resources/StatTools/RanBlock.php
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4960 0
Hospital
Name [1] 4960 0
Mater Public hospital
Country [1] 4960 0
Australia
Primary sponsor type
Hospital
Name
Mater Adults Public hospital
Address
Raymond Terrace
Brisbane
QLD 4101
Country
Australia
Secondary sponsor category [1] 4485 0
None
Name [1] 4485 0
Address [1] 4485 0
Country [1] 4485 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7060 0
Mater Human research and ethics committee (HREC)
Ethics committee address [1] 7060 0
Ethics committee country [1] 7060 0
Australia
Date submitted for ethics approval [1] 7060 0
07/10/2009
Approval date [1] 7060 0
01/03/2010
Ethics approval number [1] 7060 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29509 0
Address 29509 0
Country 29509 0
Phone 29509 0
Fax 29509 0
Email 29509 0
Contact person for public queries
Name 12756 0
Christopher Stewart
Address 12756 0
Queensland Eye Institute
41 Annerley Road
Brisbane
QLD 4101
Country 12756 0
Australia
Phone 12756 0
+617-3010-3360
Fax 12756 0
+617-3010-3390
Email 12756 0
christopher.stewart@mater.org.au
Contact person for scientific queries
Name 3684 0
James Mc Alister
Address 3684 0
Queensland Eye institute
41 Annerley Road
Brisbane
QLD 4101
Country 3684 0
Australia
Phone 3684 0
+617-3010-3360
Fax 3684 0
+617-3010-3390
Email 3684 0
jim.mcalister@qei.org.au

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.