ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Myopia

Condition category

Condition code

Eye

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]

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]

Anterior eye shape (corneal refractive power) changes will be measured using a Medmont E300 corneal topographer.

Timepoint [1]

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]

Peripheral refraction will be measured across the horizontal and vertical visual field meridians using the Shin-Nippon NVisionK 5001 autorefractor

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of New South Wales

Address [1]

School of Optometry and Vision Science
University of New South Wales
Gate 14, Barker St
Rupert Myers Building (North Wing)
Kensington, NSW, 2033

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UNSW Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

05/02/2018

Approval date [1]

08/03/2018

Ethics approval number [1]

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

Dr Pauline Kang

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

Phone

+61 2 9385 9816

Fax

[email protected]

Contact person for public queries

Name

Pauline Kang

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

Phone

+61 2 9385 9816

Fax

[email protected]

Contact person for scientific queries

Name

Pauline Kang

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

Phone

+61 2 9385 9816

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Due to confidentiality reasons, IPD will not be available.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6769	Informed consent form			[email protected]

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.

Trial Review

Documents added manually

Documents added automatically