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Trial registered on ANZCTR


Registration number
ACTRN12607000601437
Ethics application status
Approved
Date submitted
14/11/2007
Date registered
21/11/2007
Date last updated
21/11/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised, Single Centre Study of the Equivalence of Two Intraocular Lenses Used in Cataract Surgery
Scientific title
A Randomised, Single Centre Study of the Equivalence in Safety and Efficacy of Two Intraocular Lenses Used in Cataract Surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 2548 0
Condition category
Condition code
Eye 2648 2648 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The main objective of this prospective randomised study is to assess the safety and efficacy of the two Intraocular Lenses (IOL) (Alcon IOL and Tecsoft IOL) in human eyes for the treatment of cataracts. The Tecsoft IOL will be the intervention IOL and the comparator will be the Alcon IOL. The assessment of the IOL results will be based on a comparison to the patient’s preoperative condition (i.e. best spectacle corrected visual acuity and uncorrected vision) and the achieved versus expected visual and refractive outcomes, as well as an analysis of reported complications.
The patients will be followed for a one year period at intervals of 0-2 months before surgery, day of surgery (day 0), 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative.
The benefit from the two IOL’s studied being equivalent is that the very significantly cheaper Tecsoft IOL could confidently be used in cataract surgery with IOL implantation saving the Australian community millions of health dollars that could more usefully be directed to fund other new and cost effective medical technology.
Intervention code [1] 2280 0
Treatment: Devices
Comparator / control treatment
The comparator will be the Alcon IOL. The patients will be followed for a one year period at intervals of 0-2 months before surgery, day of surgery (day 0), 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative.
Control group
Active

Outcomes
Primary outcome [1] 3559 0
To assess the safety of the two Intraocular Lenses (IOL) (Alcon IOL and Tecsoft IOL) in human eyes for the treatment of cataracts. The assessment of the IOL results will be based on a comparison to the patient's preoperative condition (i.e. best spectacle corrected visual acuity and uncorrected vision) and the achieved versus expected visual and refractive outcomes, as well as an analysis of reported complications.
Timepoint [1] 3559 0
The patients will be followed for a one year period at intervals of 0-2 months before surgery, day of surgery (day 0), 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative.
Secondary outcome [1] 5958 0
To assess the efficacy of the two Intraocular Lenses (IOL) (Alcon IOL and Tecsoft IOL) in human eyes for the treatment of cataracts. The assessment of the IOL results will be based on a comparison to the patient's preoperative condition (i.e. best spectacle corrected visual acuity and uncorrected vision) and the achieved versus expected visual and refractive outcomes, as well as an analysis of reported complications.
Timepoint [1] 5958 0
The patients will be followed for a one year period at intervals of day of surgery (day 0), 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative.

Eligibility
Key inclusion criteria
Inclusion criteria:
(i) Uncomplicated age-related cataract
(ii) Males and females of at least 40 years of age.
(iii) Must understand and provide written informed consent.
(iv) Willing and able to return for scheduled postoperative follow-up examinations.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
(i) History of/or clinical signs of anterior uveitis in either eye.
(ii) Diabetic retinopathy in either eye.
(iii) Glaucoma in either eye.
(iv) Pseudoexfoliation.
(v) Amblyopia in either eye.
(vi) Blind in the fellow eye.
(vii) Central Corneal Opacity/Fuch’s Dystrophy.
(viii) Serious (i.e. life threatening) non-ophthalmic disease which may preclude study completion.
(ix) Unwilling or unable to provide written informed consent.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The IOL's will be issued by patient number according to a simple randomisation by using a computer generated randomised code.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
308
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 320 0
3002

Funding & Sponsors
Funding source category [1] 2793 0
Other
Name [1] 2793 0
BUPA Australia Health Pty Ltd
Country [1] 2793 0
Australia
Primary sponsor type
Other
Name
Centre for Eye Research Australia
Address
32 Gisborne St
East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 2523 0
None
Name [1] 2523 0
Address [1] 2523 0
Country [1] 2523 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4712 0
The Human Research Ethics Committee of the Royal Victorian Eye and Ear Hospital
Ethics committee address [1] 4712 0
Ethics committee country [1] 4712 0
Australia
Date submitted for ethics approval [1] 4712 0
Approval date [1] 4712 0
19/01/2007
Ethics approval number [1] 4712 0
06/171H

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

Contacts
Principal investigator
Name 28183 0
Address 28183 0
Country 28183 0
Phone 28183 0
Fax 28183 0
Email 28183 0
Contact person for public queries
Name 11340 0
Marios Constantinou
Address 11340 0
32 Gisborne St
East Melbourne VIC 3002
Country 11340 0
Australia
Phone 11340 0
+61 3 99298434
Fax 11340 0
Email 11340 0
mariosc@unimelb.edu.au
Contact person for scientific queries
Name 2268 0
Professor Rasik Vajpayee
Address 2268 0
32 Gisborne St
East Melbourne VIC 3002
Country 2268 0
Australia
Phone 2268 0
+61 3 99298176
Fax 2268 0
Email 2268 0
rasikv@unimelb.edu.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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Constantinou M, Jhanji V, Jing X, Lamoureux EL, Bo... [More Details]

Documents added automatically
No additional documents have been identified.