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Trial registered on ANZCTR


Registration number
ACTRN12618000151235
Ethics application status
Approved
Date submitted
25/01/2018
Date registered
1/02/2018
Date last updated
5/02/2020
Date data sharing statement initially provided
5/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The influence of orthokeratology contact lens designs on anterior eye shape in young healthy adults with myopia
Scientific title
The influence of orthokeratology lens parameters on mid-peripheral corneal topography changes in young healthy adults with myopia
Secondary ID [1] 293879 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 306345 0
Condition category
Condition code
Eye 305433 305433 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Medical device/intervention: orthokeratology contact lenses with modified lens design (custom orthokeratology lenses). Lenses will be made of Boston XO material with high oxygen permeability (100 Dk units ISO/Fatt). This material is the most common material used for conventional orthokeratology lens designs in Australia and internationally.
Exposure: 1 week of overnight lens wear during sleep (for minimum 7-8 hours) with no daytime lens wear. This is a cross-over trial where the order of lens wear (standard or custom orthokeratology lenses) will be randomised and there will be a minimum 1 week washout period of no lens wear between the two lens wearing periods.
Delivery: The research team will initially insert the lens on the subject's eye at the School of Optometry and Vision Science, UNSW, Sydney. Reseach participants will then be taught one-on-one face-to-face how to insert, remove, clean and maintain the orthokeratology lenses so that they can safely wear contact lenses during the trial period.
Compliance: Text-message reminders will be sent to monitor adherence to the intervention.
Intervention code [1] 300143 0
Treatment: Devices
Comparator / control treatment
Comparator medical device/intervention: standard orthokeratology contact lenses (standard orthokeratology lenses). Lenses will be made of Boston XO material with high oxygen permeability (100 Dk units ISO/Fatt). This material is the most common material used for conventional orthokeratology lens designs in Australia and internationally.
Exposure: 1 week of overnight lens wear during sleep (for minimum 7-8 hours) with no daytime lens wear. This is a cross-over trial where the order of lens wear (standard or custom orthokeratology lenses) will be randomised and there will be a minimum 1 week washout period of no lens wear between the two lens wearing periods.
Delivery: The research team will initially insert the lens on the subject's eye at the School of Optometry and Vision Science, UNSW, Sydney. Reseach participants will then be taught one-on-one face-to-face how to insert, remove, clean and maintain the orthokeratology lenses so that they can safely wear contact lenses during the trial period.
Compliance: Text-message reminders will be sent to monitor adherence to the control treatment.
Control group
Active

Outcomes
Primary outcome [1] 304563 0
Anterior eye shape (corneal refractive power) changes will be measured using a Medmont E300 corneal topographer.
Timepoint [1] 304563 0
Measurements will be taken at baseline before any lens wear, then after 1 and 7 nights (primary timepoint) of orthokeratology lens wear of both the standard and modified lens designs.
Secondary outcome [1] 342418 0
Peripheral refraction will be measured across the horizontal and vertical visual field meridians using the Shin-Nippon NVisionK 5001 autorefractor
Timepoint [1] 342418 0
Measurements will be taken at baseline before any lens wear, then after 1 and 7 nights of both standard and custom orthokeratology lens wear.

Eligibility
Key inclusion criteria
1. Healthy individuals aged between 18-40
2. Have short-sightedness (myopia) between -1.00D and -4.00D and less than -1.50D of corneal astigmatism
3. No previous rigid contact lens wear
4. Have good ocular health and general health
5. No contraindications to rigid contact lens wear
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Strabismus or amblyopia
2. Systemic or ocular conditions that may affect tear quality or contact lens wear
3. Previous history of ocular surgery, trauma, or chronic ocular disease
4. Ocular or systemic medication use that may interfere with contact lens wear or ocular surface
5. Not willing to comply with the allocated treatment and follow-up schedule

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/02/2018
Actual
23/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298503 0
University
Name [1] 298503 0
University of New South Wales
Country [1] 298503 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Optometry and Vision Science
University of New South Wales
Gate 14, Barker St
Rupert Myers Building (North Wing)
Kensington, NSW, 2033
Country
Australia
Secondary sponsor category [1] 297649 0
None
Name [1] 297649 0
Address [1] 297649 0
Country [1] 297649 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299483 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 299483 0
UNSW Research Ethics & Compliance Support
University of New South Wales
Gate 14, Barker St
Rupert Myers Building (South Wing)
Kensington, NSW, 2033
Ethics committee country [1] 299483 0
Australia
Date submitted for ethics approval [1] 299483 0
05/02/2018
Approval date [1] 299483 0
08/03/2018
Ethics approval number [1] 299483 0
HC180047

Summary
Brief summary
Orthokeratology (OK) lenses are rigid contact lenses that are designed to be worn during sleep. Their purpose is to reshape the front surface of the eye (cornea) in order to temporarily correct short-sightedness, also known as myopia. Although their primary aim is to correct myopia and provide clear unaided vision during the day, studies have shown that they also have an effect on slowing or stopping the progression of short-sightedness in children, termed called myopia control. This benefit is likely due to changes in mid-peripheral corneal shape and corresponding changes in peripheral vision induced by OK lenses. It has been proposed that greater changes in peripheral vision may induce better myopia control. Hence this prospective study aims to compare the effect of two different OK lens designs on mid-peripheral corneal shape changes to determine whether corneal shape changes can be predictably made through lens parameter changes. Outcomes of this study can be assist in future studies that investigate myopia control using OK lenses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80562 0
Dr Pauline Kang
Address 80562 0
School of Optometry and Vision Science
University of New South Wales
Gate 14, Barker St
Rupert Myers Building (North Wing)
Kensington, NSW, 2033
Country 80562 0
Australia
Phone 80562 0
+61 2 9385 9816
Fax 80562 0
Email 80562 0
[email protected]
Contact person for public queries
Name 80563 0
Pauline Kang
Address 80563 0
School of Optometry and Vision Science
University of New South Wales
Gate 14, Barker St
Rupert Myers Building (North Wing)
Kensington, NSW, 2033
Country 80563 0
Australia
Phone 80563 0
+61 2 9385 9816
Fax 80563 0
Email 80563 0
[email protected]
Contact person for scientific queries
Name 80564 0
Pauline Kang
Address 80564 0
School of Optometry and Vision Science
University of New South Wales
Gate 14, Barker St
Rupert Myers Building (North Wing)
Kensington, NSW, 2033
Country 80564 0
Australia
Phone 80564 0
+61 2 9385 9816
Fax 80564 0
Email 80564 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to confidentiality reasons, IPD will not be available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6769Informed consent form  [email protected]



Results publications and other study-related documents

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