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Trial registered on ANZCTR


Registration number
ACTRN12618000184279p
Ethics application status
Not yet submitted
Date submitted
30/01/2018
Date registered
5/02/2018
Date last updated
16/01/2019
Date data sharing statement initially provided
16/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of corneal outer surface shape on orthokeratology contact lens decentration in young healthy adults with short-sightedness
Scientific title
The effect of peripheral corneal shape parameters on orthokeratology contact lens decentration in young healthy adults with myopia
Secondary ID [1] 293898 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 306372 0
Condition category
Condition code
Eye 305457 305457 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of intervention: Orthokeratology contact lenses with Paragon HDS 100 (paflufocon D) 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.
The lens overall diameter is selected based on study participants' corneal diameter. The overall diameter is calculated to encompass 95% of the participant's corneal diameter.
Exposure: Study lenses are worn overnight during sleep (for minimum of 7-8 hours) over a period of 2 weeks (or 14 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 sending regular text messages to participants as reminders at all stages of the study.
Intervention code [1] 300169 0
Treatment: Devices
Comparator / control treatment
Orthokeratology contact lenses with Paragon HDS 100 (paflufocon D) material with 100 Dk units ISO/Fatt with an overall diameter 5% less than the interventional lens be used as comparator. Overall diameter is the only parameter that is different between the interventional and comparator groups. These lenses are worn after a 1 week washout period after the initial 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. Adherence to the study protocol will be ensured by investigation team sending regular text messages to participants as reminders at all stages of the study. No teaching on the use of comparator product is needed, given that the lens used is similar to the initial lens. However, instructions related to contact lens care regimen will be reminded.
Control group
Active

Outcomes
Primary outcome [1] 304603 0
A difference in the amount of treatment zone decentration will be determined (through a custom software) between interventional and comparator groups using the corneal topographic maps captured by the Medmont E300 corneal topographer.
Timepoint [1] 304603 0
Measurements will be taken at baseline before any lens wear, after 1, 7 and 14 (primary time point) nights of lens wear.
Secondary outcome [1] 342519 0
A difference in the amount of peripheral refraction will be measured using the Shin-Nippon NVisionK 5001 autorefractor between interventional and comparator groups.
Timepoint [1] 342519 0
Measurements will be taken at baseline before any lens wear, after 1, 7 and 14 nights of lens wear.

Eligibility
Key inclusion criteria
1. Individuals aged between 18 and 40 years
2. Have short sightedness between -1.00D and -5.00D with less than 1.50D of corneal astigmatism
3. Have horizontal visible iris diameter (corneal diameter) that is at least 11.5 mm
4. No contraindications for rigid contact lens wear and have not previously worn rigid contact lenses
5 Current wearers of soft contact lens will be required to discontinue 2 days prior to screening
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Persons with strabismus (squint or cross eyed) or amblyopia (lazy eye)
2. Systemic health conditions or other eye conditions that may affect the quality of tears or that may affect refractive development.
3. Previous history of eye operations, injury or chronic eye conditions.
4. Medications used for systemic or ocular health that may interfere with contact lens wear or ocular surface.
5. Not willing to comply with the located 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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
We did not recruit any participant for this study and we decided not to take this project further. This is because the results from another pilot study showed that conducting this research project at this stage is not relevant anymore.
Date of first participant enrolment
Anticipated
26/02/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298529 0
University
Name [1] 298529 0
University of New South Wales
Country [1] 298529 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] 297668 0
None
Name [1] 297668 0
Address [1] 297668 0
Country [1] 297668 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 299498 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 299498 0
Ethics committee country [1] 299498 0
Australia
Date submitted for ethics approval [1] 299498 0
05/02/2018
Approval date [1] 299498 0
Ethics approval number [1] 299498 0

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

Contacts
Principal investigator
Name 80622 0
Dr Vinod Maseedupally
Address 80622 0
School of Optometry and Vision Science
Rupert Myer Building (North Wing)
University of New South Wales
Gate 14, Barker Street
Kensington, NSW 2033
Country 80622 0
Australia
Phone 80622 0
+61 2 93855705
Fax 80622 0
Email 80622 0
vinodm@unsw.edu.au
Contact person for public queries
Name 80623 0
Vinod Maseedupally
Address 80623 0
School of Optometry and Vision Science
University of New South Wales
Sydney, NSW, 2052
Country 80623 0
Australia
Phone 80623 0
+61 2 93855705
Fax 80623 0
Email 80623 0
vinodm@unsw.edu.au
Contact person for scientific queries
Name 80624 0
Vinod Maseedupally
Address 80624 0
School of Optometry and Vision Science
University of New South Wales
Sydney, NSW, 2052
Country 80624 0
Australia
Phone 80624 0
+61 2 93855705
Fax 80624 0
Email 80624 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
No data generated from this trial


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.