Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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?
Query!
Scientific title
A prospective study to evaluate the effects of different orthokeratology lens designs on peripheral refraction in adult myopes
Query!
Secondary ID [1]
283715
0
Nil known
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Peripheral refraction in adult myopia
3772
0
Query!
Condition category
Condition code
Eye
3946
3946
0
0
Query!
Diseases / disorders of the eye
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
3483
0
Treatment: Devices
Query!
Comparator / control treatment
Participants act as their own control as described in the intervention field' in this field.
Query!
Control group
Active
Query!
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.
Query!
Assessment method [1]
4843
0
Query!
Timepoint [1]
4843
0
Peripheral refraction will be measured on day 1,4,7, 14, 28 and 42
Query!
Secondary outcome [1]
8184
0
The secondary outcome variable will be corneal topography changes as measured with the Medmont E300 topographer.
Query!
Assessment method [1]
8184
0
Query!
Timepoint [1]
8184
0
Corneal topography will be measured on day 1,4,7, 14, 28 and 42
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
40
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
1/02/2009
Query!
Actual
30/07/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
15/01/2013
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
15
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
3948
0
Government body
Query!
Name [1]
3948
0
Australian Research Council (ARC) Linkage Project Grant Scheme
Query!
Address [1]
3948
0
GPO Box 2702, Canberra, ACT 2601
Query!
Country [1]
3948
0
Australia
Query!
Funding source category [2]
3949
0
Commercial sector/Industry
Query!
Name [2]
3949
0
BE Enterprises Pty Ltd
Query!
Address [2]
3949
0
Suite 7, 12th floor, 141 Queen St,
Brisbane, QLD, 4000
Query!
Country [2]
3949
0
Australia
Query!
Funding source category [3]
3950
0
Commercial sector/Industry
Query!
Name [3]
3950
0
Capricornia Contact Lens Pty Ltd
Query!
Address [3]
3950
0
2/9 Cronulla Court,
Slacks Creek,
Brisbane, QLD, 4127
Query!
Country [3]
3950
0
Australia
Query!
Funding source category [4]
3951
0
Commercial sector/Industry
Query!
Name [4]
3951
0
Boston Products Group of Bausch & Lomb
Query!
Address [4]
3951
0
100 Research Drive,
Wilmington, Massachusetts,
01887, USA
Query!
Country [4]
3951
0
United States of America
Query!
Primary sponsor type
Individual
Query!
Name
Associate Professor Helen Swarbrick
Query!
Address
School of Optometry and Vision Science,
University of New South Wales,
Sydney, NSW, 2052
Query!
Country
Australia
Query!
Secondary sponsor category [1]
3837
0
None
Query!
Name [1]
3837
0
Query!
Address [1]
3837
0
Query!
Country [1]
3837
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
6010
0
University of New South Wales Human Research Ethics Committee
Query!
Ethics committee address [1]
6010
0
University of New South Wales, Sydney, NSW 2052
Query!
Ethics committee country [1]
6010
0
Australia
Query!
Date submitted for ethics approval [1]
6010
0
Query!
Approval date [1]
6010
0
Query!
Ethics approval number [1]
6010
0
Query!
Summary
Brief summary
This study aims to determine the lens parameters in orthokeratology lenses that allow manipulation of peripheral refraction in adult myopes. Additionally, relationships between corneal topography and peripheral refraction changes induced by orthokeratology lenses will be investigated.
Query!
Trial website
Query!
Trial related presentations / publications
*Kang P, Gifford P, Swarbrick H. Can manipulation of OK lens parameters modify peripheral refraction? Optom Vis Sci 2013; 90: 1237-1248
*Kang P, Swarbrick H. Time course of the effects of orthokeratology on peripheral refraction and corneal topography. Ophthalmic Physiol Opt 2013; 33:277-82
*Kang P, Swarbrick H. Time course of the effects of orthokeratology on peripheral refraction and corneal topography. Invest Ophthalmol Vis Sci 2012 53, E-Abstract 4713
*Kang P, Gifford P, Swarbrick H. Peripheral refraction and corneal topography changes with different orthokeratology lens designs. 14th International Myopia Conference (IMC), USA, August 2013 (Poster)
*Kang P, Gifford P, Swarbrick H. Can manipulation of OK lens parameters change the peripheral refraction profile? American Academy of Optometry's 91st annual meeting, Phoenix, USA October 2012 (Presentation)
*Kang P. Future myopia research – where will it take us? 14th International Cornea and Contact Lens Congress (ICCLC), Sydney, Australia October 2012 (Presentation)
*Kang P, Swarbrick H. Orthokeratology, peripheral refraction and myopia control. 10th Congress of the Orthokeratology Society of Oceania, Gold Coast, Australia July 2012 (Presentation)
*Kang P. Potential for myopia control with orthokeratology lenses through manipulation of peripheral ocular refraction. CCLSA Vic chapter, Melbourne, Australia August 2011 (Presentation)
Query!
Public notes
Query!
Contacts
Principal investigator
Name
28989
0
Prof Helen Swarbrick
Query!
Address
28989
0
School of Optometry and Vision Science, University of New South Wales, Sydney 2052
Query!
Country
28989
0
Australia
Query!
Phone
28989
0
+612 9385 4373
Query!
Fax
28989
0
Query!
Email
28989
0
[email protected]
Query!
Contact person for public queries
Name
12146
0
Prof Prof Helen Swarbrick
Query!
Address
12146
0
School of Optometry and Vision Science,
University of New South Wales,
Sydney 2052
Query!
Country
12146
0
Australia
Query!
Phone
12146
0
+612 9385 4373
Query!
Fax
12146
0
+612 9313 6243
Query!
Email
12146
0
[email protected]
Query!
Contact person for scientific queries
Name
3074
0
Prof Prof Helen Swarbrick
Query!
Address
3074
0
School of Optometry and Vision Science,
University of New South Wales,
Sydney 2052
Query!
Country
3074
0
Australia
Query!
Phone
3074
0
+612 9385 4373
Query!
Fax
3074
0
+612 9313 6243
Query!
Email
3074
0
[email protected]
Query!
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.
Download to PDF