Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000731099
Ethics application status
Approved
Date submitted
1/09/2010
Date registered
2/09/2010
Date last updated
26/02/2019
Date data sharing statement initially provided
26/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Orthokeratology for presbyopia: Exploring refractive and corneal changes in hyperopic orthokeratology lens wear for correction of near vision in presbyopic patients
Scientific title
A prospective, repeated measures study investigating the effect of hyperopic orthokeratology lens wear on corneal shape and refractive status in healthy presbyopic patients, when worn to correct near vision
Secondary ID [1] 252609 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractive correction for presbyopia 258105 0
Condition category
Condition code
Eye 258284 258284 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Presbyopic participants will be asked to wear hyperopic orthokeratology lenses in one eye overnight only for a period up to 90 days. Boston Simplus solution will be used for cleaning and disinfection while lenses are not being worn.
Intervention code [1] 257127 0
Treatment: Devices
Intervention code [2] 257134 0
Treatment: Other
Comparator / control treatment
Lenses will be worn in one eye only. The fellow eye will act as a non-lens wearing control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259127 0
Change in refractive status (Best vision sphere - Dioptres), using a Shin-Nippon NVision K5001 autorefractor and subjective routines used in standard optometric practice
Timepoint [1] 259127 0
Baseline, and AM (within 1 hour of waking) and PM (8-hours after AM) after 1, 7, 30, 60, and 90 nights of lens wear
Primary outcome [2] 259128 0
Change in ocular aberrations will be measured using the Nidek OPD Scan II aberrometer corneal topographer
Timepoint [2] 259128 0
Baseline, and AM (within 1 hour of waking) and PM (8-hours after AM) after 1, 7, 30, 60, and 90 nights of lens wear
Primary outcome [3] 259129 0
Change in corneal curvature will be measured using the Medmont E300 corneal topographer
Timepoint [3] 259129 0
Baseline, and AM (within 1 hour of waking) and PM (8-hours after AM) after 1, 7, 30, 60, and 90 nights of lens wear
Secondary outcome [1] 265446 0
Contact lens fitting and centration
Timepoint [1] 265446 0
Baseline, and at AM (within 1 hour of waking) after 1, 7, 30, 60, and 90 nights of lens wear

Eligibility
Key inclusion criteria
Good ocular health, No contraindications to contact lens wear, Central corneal radius between 7.00mm & 8.40mm, Less than 1.50D of with-the-rule corneal astigmatism
Minimum age
45 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Rigid contact lens wearers, active ocular pathology, Systemic disease or use of medications that may affect the eye or be exacerbated by wearing contact lenses, history of corneal surgery including refractive surgery, pregnancy

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/09/2010
Actual
24/06/2011
Date of last participant enrolment
Anticipated
Actual
2/07/2012
Date of last data collection
Anticipated
Actual
2/10/2012
Sample size
Target
20
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257568 0
Government body
Name [1] 257568 0
Australian Research Council (ARC) Linkage Project Grant Scheme
Country [1] 257568 0
Australia
Funding source category [2] 257569 0
Commercial sector/Industry
Name [2] 257569 0
Bausch & Lomb Boston
Country [2] 257569 0
United States of America
Funding source category [3] 257570 0
Commercial sector/Industry
Name [3] 257570 0
BE Enterprises Pty Ltd
Country [3] 257570 0
Australia
Funding source category [4] 257571 0
Commercial sector/Industry
Name [4] 257571 0
Capricornia Contact Lens Pty Ltd
Country [4] 257571 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Helen Swarbrick
Address
School of Optometry and Vision Science, The University of New South Wales, Rupert Myers Building (North), Kensington, UNSW Sydney, NSW 2052
Country
Australia
Secondary sponsor category [1] 256794 0
None
Name [1] 256794 0
Address [1] 256794 0
Country [1] 256794 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259593 0
Human Research Ethics Committee
Ethics committee address [1] 259593 0
Ethics committee country [1] 259593 0
Australia
Date submitted for ethics approval [1] 259593 0
25/06/2010
Approval date [1] 259593 0
20/09/2010
Ethics approval number [1] 259593 0
10200

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

Contacts
Principal investigator
Name 31592 0
Address 31592 0
Country 31592 0
Phone 31592 0
Fax 31592 0
Email 31592 0
Contact person for public queries
Name 14839 0
Associate Professor Helen Swarbrick
Address 14839 0
School of Optometry and Vision Science
Rupert Myers Building North
University of New South Wales
UNSW Sydney
NSW 2052
Country 14839 0
Australia
Phone 14839 0
+61 2 9385 4373
Fax 14839 0
Email 14839 0
[email protected]
Contact person for scientific queries
Name 5767 0
Associate Professor Helen Swarbrick
Address 5767 0
School of Optometry and Vision Science
Rupert Myers Building North
University of New South Wales
UNSW Sydney
NSW 2052
Country 5767 0
Australia
Phone 5767 0
+61 2 9385 4373
Fax 5767 0
Email 5767 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.