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Trial registered on ANZCTR


Registration number
ACTRN12619000849190p
Ethics application status
Submitted, not yet approved
Date submitted
17/05/2019
Date registered
14/06/2019
Date last updated
14/06/2019
Date data sharing statement initially provided
14/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
What does open eye lens centration tell us about the treatment zone centration after overnight wear of orthokeratology (OK) lenses?
Scientific title
What does open eye lens centration tell us about the treatment zone centration after overnight wear of orthokeratology (OK) lenses in eyes with Myopia?
Secondary ID [1] 298262 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 312870 0
Condition category
Condition code
Eye 311368 311368 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of intervention: BE Orthokeratology contact lenses (Capricornia Contact Lens, Brisbane, Australia) in Boston XO material with 100 Dk units ISO/Fatt are used in this study. This is one of the most common materials used for conventional orthokeratology in Australia and abroad.

Exposure: Study lenses are worn overnight during sleep (for minimum of 7-8 hours) over a period of 3 nights with no need for day time 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. Research participants will then be taught one-on-one face-to-face how to insert, remove, clean and maintain orthokeratology lenses so that subjects can safely wear contact lenses during the trial period.
Adherence to the study protocol will be ensured by investigation team advising participants to complete a "Ortho-K Wear Time Journal” to record your OK lens insertion and removal times as well as sleep and waking up times.
Intervention code [1] 314509 0
Treatment: Devices
Comparator / control treatment
Description of intervention: BE Orthokeratology contact lenses (Capricornia Contact Lens, Brisbane, Australia) in Boston XO material with 100 Dk units ISO/Fatt are used in this study. This is one of the most common materials used for conventional orthokeratology in Australia and abroad.

Exposure: Study lenses are worn for a about half hour during open eye conidtion at the research facility at the time of dispensing and then worn overnight during sleep (for minimum of 7-8 hours) over a period of 3 nights with no need for day time 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. Research participants will then be taught one-on-one face-to-face how to insert, remove, clean and maintain orthokeratology lenses so that subjects can safely wear contact lenses during the trial period.
Adherence to the study protocol will be ensured by investigation team advising participants to complete a "Ortho-K Wear Time Journal” to record your OK lens insertion and removal times as well as sleep and waking up times.

Comparator is 'no treatment' situation therefore the lens centration and treatment zone decentration after the open eye and closed eye situations respectively are compared to zero (no treatment). The open eye lens decentration recorded at the time of lens dispensing and compared to zero (no treatment) and the overnight treatment zone parameters are also compared to zero (no treatment). The amount of open eye lens decentration and the treatment zone decentration after overnight wear are also compared.

Control group
Active

Outcomes
Primary outcome [1] 320096 0
The open eye lens decentration recorded at the time of lens dispensing and compared to zero (no treatment)

The open eye decentration is measured using a custom designed software (i-Metrics) from the eye videos captured at the time of lens dispensing. The software allows the user to trace the decentred lens position on the captured video, thus determining the amount of decentration in open eye condition from zero (no treatment)
Timepoint [1] 320096 0
At baseline.
Study (lens decentration) measurements will be determined from the digital videos captured within 15-20 minutes after lens insertion at baseline.
Primary outcome [2] 320176 0
The closed eye treatment zone decentration recorded after one night and three nights of wear is compared to zero (no treatment)

Study (treatment zone decentration) measurements will be determined from the corneal topography images captured after one night and three nights of lens wear. A custom written software program developed at the University of New South Wales allows the investigator to delineate the treatment zone from the coloured topography maps captured at these time points thus determining the amount of treatment zone decentration from zero (no treatment)
Timepoint [2] 320176 0
one and three nights of wear.
Secondary outcome [1] 370529 0
Eyelid morphometry features (including palpebral fissure height, position of eyelids relative to limbus, eyelid slant etc) are assessed using the i-Metrics software. Assessing Eyelid morphometry features is an exploratory composite secondary outcome. The investigator uploads the images (derived from the digital videos) of the anterior eye captured at the first visit into the software. The investigator then draws the outline of upper and lower eyelids, limbus, pupil etc. The software then calculates the relative distances between each of the outlined features.
Timepoint [1] 370529 0
First study visit (baseline)

Eligibility
Key inclusion criteria
• Males and females over 18 years of age
• Good ocular and general health
• Refractive error -1.00D to -6.00D and corneal toricity (astigmatism) <1.50D
• Anisometropia (difference spectacle power between the two eyes) <1.00D
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any previous rigid gas permeable, including orthokeratology lens wearers
• Soft contact lens wear in the past week
• Contraindications to rigid lens wear, including orthokeratology lens wearers

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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2019
Actual
Date of last participant enrolment
Anticipated
30/11/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
13
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302807 0
University
Name [1] 302807 0
University of New South Wales
Country [1] 302807 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Optometry and Vision Science Rupert Myer Building (North Wing) University of New South Wales
Gate 14, Barker Street Kensington, NSW 2033
Country
Australia
Secondary sponsor category [1] 302753 0
None
Name [1] 302753 0
Address [1] 302753 0
Country [1] 302753 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303391 0
UNSW Human Research Ethics Advisory Panel
Ethics committee address [1] 303391 0
Ethics committee country [1] 303391 0
Australia
Date submitted for ethics approval [1] 303391 0
20/05/2019
Approval date [1] 303391 0
Ethics approval number [1] 303391 0

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

Contacts
Principal investigator
Name 93514 0
Dr Vinod Maseedupally
Address 93514 0
School of Optometry and Vision Science
University of New South Wales
Gate 14, Barker Street Kensington, NSW 2033
Country 93514 0
Australia
Phone 93514 0
+61 2 9385 9233
Fax 93514 0
Email 93514 0
vinodm@unsw.edu.au
Contact person for public queries
Name 93515 0
Vinod Maseedupally
Address 93515 0
School of Optometry and Vision Science
University of New South Wales
Gate 14, Barker Street Kensington, NSW 2033
Country 93515 0
Australia
Phone 93515 0
+61 2 9385 9233
Fax 93515 0
Email 93515 0
vinodm@unsw.edu.au
Contact person for scientific queries
Name 93516 0
Vinod Maseedupally
Address 93516 0
School of Optometry and Vision Science
University of New South Wales
Gate 14, Barker Street Kensington, NSW 2033
Country 93516 0
Australia
Phone 93516 0
+61 2 9385 9233
Fax 93516 0
Email 93516 0
vinodm@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?

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.