Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000077369
Ethics application status
Approved
Date submitted
8/02/2008
Date registered
13/02/2008
Date last updated
26/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of partial coherence tonometry and ultrasound biometry
Scientific title
Double-blind randomised clinical trial comparison of partial coherence interferometry and ultrasound biometry for the determination of intraocular lens power measured by the postoperative refractive outcome
Secondary ID [1] 283083 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract
Preoperative biometry
Cataract surgery 2802 0
Condition category
Condition code
Eye 2937 2937 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Preoperative biometry of axial length using partial coherence interferometry. This measurement is done at a single preadmission clinic visit.
Intervention code [1] 2541 0
Treatment: Surgery
Comparator / control treatment
Preoperative biometry of axial length using applanation ultrasound. This measurement is done at a single preadmission clinic visit.
Control group
Active

Outcomes
Primary outcome [1] 3820 0
Postoperative refraction, measured as absolute postoperative refractive error
Timepoint [1] 3820 0
Five weeks after surgery
Secondary outcome [1] 6444 0
Visual function survey, VF-14
Timepoint [1] 6444 0
Two months after surgery

Eligibility
Key inclusion criteria
Patients referred for consideration of age-related cataract surgery, approved for surgery and consented to surgery
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
A simple random sample of 205 out of 410 patients consecutively booked for surgery were assigned as trial participants using a lottery method. Each patient had an equal probability of being assigned as a trial participant and each was assigned independently. Opaque envelopes were used.
Participants were then randomised into treatment groups by lottery method, by opaque envelopes, with each participant having equal probability of being allocated to either treatment group and each was assigned independently.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/04/2006
Actual
6/04/2006
Date of last participant enrolment
Anticipated
Actual
24/08/2006
Date of last data collection
Anticipated
Actual
Sample size
Target
205
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 569 0
3977

Funding & Sponsors
Funding source category [1] 3061 0
Hospital
Name [1] 3061 0
Ophthalmology Unit Southern Health
Country [1] 3061 0
Australia
Primary sponsor type
Hospital
Name
Ian Favilla
Address
Ophthalmology Unit Southern Health,
Monash University Department of Surgery,
Level 5 Block E,
Monash Medical Centre,
246 Clayton Rd,
Clayton 3168,
Victoria
Country
Australia
Secondary sponsor category [1] 2758 0
None
Name [1] 2758 0
Address [1] 2758 0
Country [1] 2758 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5012 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 5012 0
Ethics committee country [1] 5012 0
Date submitted for ethics approval [1] 5012 0
Approval date [1] 5012 0
Ethics approval number [1] 5012 0

Summary
Brief summary
The objective of this trial was specifically aimed at answering the research question: For the general cataract population, does the use of partial coherence interferometry improve postoperative outcomes compared with current generation applanation ultrasound biometry, as measured by postoperative refractive error, by increasing the accuracy of calculation of the intraocular lens power.
Trial website
Trial related presentations / publications
Raymond S, Favilla I, Santamaria L. Comparing ultrasound biometry with partial coherence interferometry for intraocular lens power calculations: a randomized study. Invest Ophthalmol Vis Sci 2009; 50(6): 2547-2552.
Public notes

Contacts
Principal investigator
Name 28357 0
Ms Linda Santamaria
Address 28357 0
Monash University Department of Surgery, Level 5 Block E, Monash Medical Centre, 246 Clayton Rd, Clayton 3168, Victoria
Country 28357 0
Australia
Phone 28357 0
+61395945502
Fax 28357 0
Email 28357 0
[email protected]
Contact person for public queries
Name 11514 0
Ms Linda Santamaria
Address 11514 0
Monash University Department of Surgery,
Level 5 Block E,
Monash Medical Centre,
246 Clayton Rd,
Clayton 3168,
Victoria
Country 11514 0
Australia
Phone 11514 0
03 9594 5502
Fax 11514 0
Email 11514 0
[email protected]
Contact person for scientific queries
Name 2442 0
Ms Linda Santamaria
Address 2442 0
Monash University Department of Surgery, Level 5 Block E, Monash Medical Centre, 246 Clayton Rd, Clayton 3168, Victoria
Country 2442 0
Australia
Phone 2442 0
+61395945502
Fax 2442 0
Email 2442 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.