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Trial registered on ANZCTR


Registration number
ACTRN12624001436561p
Ethics application status
Submitted, not yet approved
Date submitted
9/11/2024
Date registered
9/12/2024
Date last updated
9/12/2024
Date data sharing statement initially provided
9/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
How often orthokeratology lenses need to be replaced?
Scientific title
Evaluation of Orthokeratology Lens Replacement Frequency in Individuals Undergoing Vision Correction: A Longitudinal Study
Secondary ID [1] 313341 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 335697 0
Condition category
Condition code
Eye 332260 332260 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be fitted with orthokeratology lenses (Menicon Z Night lenses) following the manufacturer's guidelines. These lenses are made from Tisilfocon A, a safe and rigid gas-permeable material with a reverse geometry design, which are approved by the Therapeutic Goods Administration (TGA) in Australia (ARTG number: 226883) for overnight wear. They are designed to be worn while sleeping to help correct short-sightedness, also known as myopia. The power of these lenses will slightly differ from spectacle power, as they sit close to the eye surface.
Participants will be instructed to wear the lenses overnight for at least 6 hours. Participants will be reviewed at regular visits (Screening visit, baseline visit, 1 day, 7 days, 21 days, 6 months, 12 months and 2 weeks lens cessation visit). Both lenses will be worn continuously for six months. At the six-month visit, a new lens with similar parameters will be dispensed for the right eye, while the original lens will undergo quantitative surface assessment. The left eye lens will continue to be worn until the 12-month visit, where it will also undergo a similar assessment. Participants will receive handouts detailing insertion, removal, and cleaning instructions, along with an "O-K Wear Time Journal" to log their lens usage, including bedtime and wake times. All visits will be scheduled in the morning, approximately 45–60 minutes in duration, within two hours of waking. During these visits, the lens care regimen and hygiene practices will be reinforced, and the 'O-K Wear Time Journal' will be reviewed. At each visit, the anterior surface of the eye will be examined using clinical microscope, and lens comfort levels will be assessed using Ocular Surface Disease Index questionnaire (OSDI) and Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8). Additionally, lens spoilage will be qualitatively assessed through photography at each visit. During the lens dispensing, six-month, and one-year visits, lens deposition will also be quantitatively evaluated using established standard laboratory procedures.
Intervention code [1] 329926 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339832 0
Orthokeratology lens spoilage grading scores. All measures will be assessed as a composite primary outcome.
Timepoint [1] 339832 0
Qualitative assessment will conducted in baseline visits, 1 day, 7 days, 21 days, 6 months, and 12 months post-baseline.
Quantitative assessment will be conducted at baseline visit, 6-month visit and the left eye lens at the 12-month post-baseline visit.
Secondary outcome [1] 441577 0
Contact lens Comfort
Timepoint [1] 441577 0
Contact lens Comfort and ocular surface changes will assessed in baseline visit, 1 day, 7 days, 21 days, 6 months, and 12 months post-baseline.
Secondary outcome [2] 442217 0
Ocular surface changes.
Timepoint [2] 442217 0
Ocular surface changes will be assessed in baseline visit, 1 day, 7 days, 21 days, 6 months, and 12 months post-baseline.

Eligibility
Key inclusion criteria
• Age between 18 to 40
• Have refractive error between -1.00 and -4.00D of Sphere, Astigmatism less than or equal to 2.50D.
• Good eye health with no history of eye trauma or surgery, no eye disease
• Soft contact lens wearers willing to discontinue lens wear for at least 24 hours before participation. Individuals with or without a history of wearing rigid lenses (including orthokeratology) for a short-term (less than or equal to 3months) and have discontinued wearing them for one month.
• Good general health and no medications which may influence eye health.
• Willing and able to comply with the research procedures and follow-up schedule.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age less than 18 years-old and more than 40 years-old
• Refractive error between less than -1.00D and more than -4.00D, astigmatism >2.50

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)
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
Not yet recruiting
Date of first participant enrolment
Anticipated
10/12/2024
Actual
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
27/02/2026
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317789 0
University
Name [1] 317789 0
University of New South Wales
Country [1] 317789 0
Australia
Primary sponsor type
Individual
Name
Prof Mark Willcox, University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 320108 0
None
Name [1] 320108 0
Address [1] 320108 0
Country [1] 320108 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316472 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 316472 0
Ethics committee country [1] 316472 0
Australia
Date submitted for ethics approval [1] 316472 0
07/11/2024
Approval date [1] 316472 0
Ethics approval number [1] 316472 0

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

Contacts
Principal investigator
Name 138002 0
Dr Mark Willcox
Address 138002 0
School of Optometry and Vision Science, Rupert Myers Building, Level 3/North Wing, UNSW, Randwick 2031, NSW,
Country 138002 0
Australia
Phone 138002 0
+61 2 9385 9233
Fax 138002 0
Email 138002 0
m.willcox@unsw.edu.au
Contact person for public queries
Name 138003 0
Mark Willcox
Address 138003 0
School of Optometry and Vision Science, Rupert Myers Building, Level 3/North Wing, UNSW, Randwick 2031, NSW.
Country 138003 0
Australia
Phone 138003 0
+61 2 9385 9233
Fax 138003 0
Email 138003 0
m.willcox@unsw.edu.au
Contact person for scientific queries
Name 138004 0
Mark Willcox
Address 138004 0
School of Optometry and Vision Science, Rupert Myers Building, Level 3/North Wing, UNSW, Randwick 2031, NSW
Country 138004 0
Australia
Phone 138004 0
+61 2 9385 9233
Fax 138004 0
Email 138004 0
m.willcox@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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24322Study protocol    388736-(Uploaded-09-11-2024-18-39-31)-20241104_J_J OrthoK_Protocol_V1.pdf
24323Informed consent form    388736-(Uploaded-09-11-2024-18-40-05)-20241104_J_J_PISCF_Clean_V2.pdf



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.