Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000068268
Ethics application status
Approved
Date submitted
25/11/2008
Date registered
27/01/2009
Date last updated
20/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The future of corneal refractive reshaping: can we control myopia through the manipulation of peripheral refraction using orthokeratology lenses?
Scientific title
A prospective study to evaluate the effects of different orthokeratology lens designs on peripheral refraction in adult myopes
Secondary ID [1] 283715 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral refraction in adult myopia 3772 0
Condition category
Condition code
Eye 3946 3946 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adult subjects with myopia will wear orthokeratology lenses (BE design; Boston XO2 material) in both eyes on an overnight basis, only worn while asleep, for a 6 week period. Baseline measurements will be obtained from the first two weeks of lens wear. All subjects will then be asked to cease lens wear for the following 2 weeks. All subjects will then be asked to wear different orthokeratology lenses for the subsequent 2 weeks on an overnight basis only while asleep. The lens design worn during the second period of wear will also be of BE design and made from Boston XO2 material, however the lens parameters will be altered. In one eye, the lens edge lift angle will be reduced to create a tighter peripheral lens fit while the other eye will have the lens optic zone diameter decreased from 6mm to 5mm. The measurements from this second lens wear period will be compared with those obtained from baseline lens wear.
Intervention code [1] 3483 0
Treatment: Devices
Comparator / control treatment
Participants act as their own control as described in the intervention field' in this field.
Control group
Active

Outcomes
Primary outcome [1] 4843 0
The primary outcome variable will be peripheral refraction change at 5 degree increments along the horizontal meridian as measured using the Shin-Nippon NVision K-5001 autorefractor.
Timepoint [1] 4843 0
Peripheral refraction will be measured on day 1,4,7, 14, 28 and 42
Secondary outcome [1] 8184 0
The secondary outcome variable will be corneal topography changes as measured with the Medmont E300 topographer.
Timepoint [1] 8184 0
Corneal topography will be measured on day 1,4,7, 14, 28 and 42

Eligibility
Key inclusion criteria
Participants will require to have a myopic refractive error between -0.75 to -4.00D and less than 1.50D with-the-rule astigmatism. Participants must have good general and ocular health, no medications which may influence ocular health and no history of rigid contact lens wear.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Potential subjects will not be enrolled if they show any contraindications for rigid contact lens wear, ocular pathology or active ocular surface disease that would preclude contact lens wear.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2009
Actual
30/07/2009
Date of last participant enrolment
Anticipated
Actual
15/01/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3948 0
Government body
Name [1] 3948 0
Australian Research Council (ARC) Linkage Project Grant Scheme
Country [1] 3948 0
Australia
Funding source category [2] 3949 0
Commercial sector/Industry
Name [2] 3949 0
BE Enterprises Pty Ltd
Country [2] 3949 0
Australia
Funding source category [3] 3950 0
Commercial sector/Industry
Name [3] 3950 0
Capricornia Contact Lens Pty Ltd
Country [3] 3950 0
Australia
Funding source category [4] 3951 0
Commercial sector/Industry
Name [4] 3951 0
Boston Products Group of Bausch & Lomb
Country [4] 3951 0
United States of America
Primary sponsor type
Individual
Name
Associate Professor Helen Swarbrick
Address
School of Optometry and Vision Science,
University of New South Wales,
Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 3837 0
None
Name [1] 3837 0
Address [1] 3837 0
Country [1] 3837 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6010 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 6010 0
Ethics committee country [1] 6010 0
Australia
Date submitted for ethics approval [1] 6010 0
Approval date [1] 6010 0
Ethics approval number [1] 6010 0

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

Contacts
Principal investigator
Name 28989 0
Prof Helen Swarbrick
Address 28989 0
School of Optometry and Vision Science, University of New South Wales, Sydney 2052
Country 28989 0
Australia
Phone 28989 0
+612 9385 4373
Fax 28989 0
Email 28989 0
h.swarbrick@unsw.edu.au
Contact person for public queries
Name 12146 0
Prof Helen Swarbrick
Address 12146 0
School of Optometry and Vision Science,
University of New South Wales,
Sydney 2052
Country 12146 0
Australia
Phone 12146 0
+612 9385 4373
Fax 12146 0
+612 9313 6243
Email 12146 0
h.swarbrick@unsw.edu.au
Contact person for scientific queries
Name 3074 0
Prof Helen Swarbrick
Address 3074 0
School of Optometry and Vision Science,
University of New South Wales,
Sydney 2052
Country 3074 0
Australia
Phone 3074 0
+612 9385 4373
Fax 3074 0
+612 9313 6243
Email 3074 0
h.swarbrick@unsw.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.