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Trial registered on ANZCTR


Registration number
ACTRN12618000278235
Ethics application status
Approved
Date submitted
15/02/2018
Date registered
22/02/2018
Date last updated
16/07/2021
Date data sharing statement initially provided
5/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of orthokeratology contact lens wear on anterior eye stem cells in young healthy myopic adults
Scientific title
The effect of orthokeratology contact lens wear on limbal stem cells in young healthy myopic adults
Secondary ID [1] 294062 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myopia 306618 0
Condition category
Condition code
Eye 305721 305721 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Medical device: TGA approved Paragon CRT orthokeratology contact lenses (ARTG no.299388). These lenses will be made from Paragon HDS100 material which has high oxygen permeability (101 Dk units ISO/Fatt).
Exposure: 2 weeks of overnight lens wear during sleep (for minimum 7-8 hours) with no daytime lens wear.
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] 300337 0
Treatment: Devices
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304797 0
Limbal stem cell changes measured with a confocal microscope (Heidelberg Retina Tomography III Rodenstock corneal module)
Timepoint [1] 304797 0
Measurements will be taken at baseline before any lens wear, then after 1, 7 and 14 (primary time point) nights of orthokeratology lens wear.
Secondary outcome [1] 343224 0
Anterior eye shape changes will be measured using the Medmont E300 corneal topographer and Tomey Casia SS-1000 anterior eye optical coherence tomographer.
Timepoint [1] 343224 0
Measurements will be taken at baseline before any lens wear, then after 1, 7 and 14 nights of orthokeratology lens wear.

Eligibility
Key inclusion criteria
1. Healthy individuals aged between 18-40
2. Have short-sightedness (myopia) between -1.ooD and -6.ooD and less than -1.50D of corneal astigmatism
3. No previous soft or 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Systemic or ocular conditions that may affect tear quality or contact lens wear
2. Previous history of ocular surgery, trauma, or chronic ocular disease
3. Ocular or systemic medication use that may interfere with contact lens wear or ocular surface
4. Previous reactions or allergies to any ocular medications
5. Not willing to comply with the allocated treatment and follow-up schedule

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
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298707 0
Commercial sector/Industry
Name [1] 298707 0
Paragon Vision Sciences
Address [1] 298707 0
947 E Impala Avenue
Mesa, AZ, 85204
Country [1] 298707 0
United States of America
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] 297877 0
None
Name [1] 297877 0
Address [1] 297877 0
Country [1] 297877 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299641 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 299641 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] 299641 0
Australia
Date submitted for ethics approval [1] 299641 0
20/02/2018
Approval date [1] 299641 0
31/03/2018
Ethics approval number [1] 299641 0
HC180087

Summary
Brief summary
Orthokeratology contact lenses are specialised rigid contact lenses are worn overnight and are removed in the morning. During overnight wear, orthokeratology lenses temporarily change the shape of the front surface of the eye, or cornea, which acts to correct mild to moderate degrees of myopia, providing wearers clear unaided vision throughout the day. The renewal and regeneration of corneal cells are important for maintaining transparency of the cornea which is crucial for clear vision. Surrounding the clear cornea is the limbus or limbal region which contains the stem cells that are responsible for maintaining renewal and regeneration of corneal cells and thus it's clarity. Previous studies have demonstrated changes to the limbal stem cells associated with soft contact lens wear. A deficiency in limbal cells can lead to decreased vision. Although orthokeratology lenses have a smaller overall diameter than soft contact lenses, its proximity to the limbus and rigid nature of the lens raises the question of whether there are any mechanical impacts on the limbal region associated with lens movement which may lead to changes in limbal stem cells. This study aims to investigate if there are any associated limbal changes with orthokeratology lens wear.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81138 0
Dr Pauline Kang
Address 81138 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 81138 0
Australia
Phone 81138 0
+61 2 9385 9816
Fax 81138 0
Email 81138 0
p.kang@unsw.edu.au
Contact person for public queries
Name 81139 0
Dr Pauline Kang
Address 81139 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 81139 0
Australia
Phone 81139 0
+61 2 9385 9816
Fax 81139 0
Email 81139 0
p.kang@unsw.edu.au
Contact person for scientific queries
Name 81140 0
Dr Pauline Kang
Address 81140 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 81140 0
Australia
Phone 81140 0
+61 2 9385 9816
Fax 81140 0
Email 81140 0
p.kang@unsw.edu.au

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?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 6770 0
Informed consent form
Citation [1] 6770 0
Link [1] 6770 0
Email [1] 6770 0
p.kang@unsw.edu.au
Other [1] 6770 0
Attachment [1] 6770 0
Summary results
No Results