ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000671268

Ethics application status

Approved

Date submitted

9/04/2018

Date registered

24/04/2018

Date last updated

28/01/2022

Date data sharing statement initially provided

28/01/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

The effect of lens diameter on orthokeratology lens centration

Scientific title

The effect of lens diameter on orthokeratology lens centration

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

Intervention: standard orthokeratology rigid contact lenses with 10.5 mm total lens diameter
Materials: Lenses will be made from paragon HDS 100 material with high oxygen permeability (100 Dk units ISO/Fatt). This is a material that is commonly used for conventional orthokeratology lens designs.
Exposure: 2 weeks of overnight lens wear during sleep (for minimum 7-8 hours) with no day time lens wear. Following this 2 week lens wear period, this trial will involve a minimum 2 week wash out period of no lens wear after which the comparator orthokeratology lenses will be worn for another 2 weeks.
Delivery and location: The research team will initially insert the lens on the research participants's eye at the School of Optometry and Vision Science, UNSW, Sydney. Lenses will be provided individually and once at the beginning of the trial.
Supporting procedures: Research participants will then be taught one-on-one face-to-face how to insert, remove clean and maintain orthokeratology lenses so that they can safely wear the contact lenses during the trial period

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Intervention: comparator orthokeratology rigid contact lenses with either 10.0 mm or 11.0 mm total lens diameter. Research participants with horizontal visible iris diameter 11.5 mm will be given lenses with 11.0 mm total lens diameter. Those with horizontal visible iris diameter of less than 11.5 mm will be given lenses with 10.0 mm total lens diameter.
Materials: Lenses will be made from paragon HDS 100 material with high oxygen permeability (100 Dk units ISO/Fatt). This is a material that is commonly used for conventional orthokeratology lens designs.
Exposure: After 2 weeks of overnight lens wear during sleep of the standard orthokeratology lens, research participants will undergo a minimum 2 week wash out period of no lens wear. Following this wash out period, research participants will be given the comparator orthokeratology lenses will be worn for another 2 weeks during sleep (for minimum 7-8 hours) with no day time lens wear.
Delivery and location: The research team will initially insert the lens on the Research participants's eye at the School of Optometry and Vision Science, UNSW, Sydney. Lenses will be provided individually and once at the beginning of the trial.
Supporting procedures: Research participants will then be taught one-on-one face-to-face how to insert, remove clean and maintain orthokeratology lenses so that they can safely wear the contact lenses during the trial period

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Anterior eye shape (corneal refractive power) changes measured using the Medmont E300 corneal topographer.

Timepoint [1]

Measurements will be taken at baseline before any lens wear, then after 1, 7, and 14 nights (primary timepoint) of orthokeratology lens wear of both the standard and comparator designs

Secondary outcome [1]

Central refraction will be measured using the Shin-Nippon NVision-K 5001 autorefractor.

Timepoint [1]

Measurements will be taken at baseline before any lens wear, then after 1, 7, and 14 nights of orthokeratology lens wear of both the standard and comparator designs

Secondary outcome [2]

Visual acuity will be measured using a computerised vision chart.

Timepoint [2]

Measurements will be taken at baseline before any lens wear, then after 1, 7, and 14 nights of orthokeratology lens wear of both the standard and comparator designs

Eligibility

Key inclusion criteria

1. Healthy individuals aged 18 to 40 years
2. Have short sightedness between -1.00D and -6.00D and less than -1.50D of corneal astigmatism
3. Have good ocular and general health
4. No contraindications for rigid contact lens wear and have not previously worn rigid contact lenses
5. Horizontal visible iris diameter 11 mm or greater

Minimum age

18 Years

Maximum age

40 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. No 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. Not willing to comply with allocated treatment and follow-up schedules

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

Completed

Date of first participant enrolment

Anticipated

Actual

14/06/2017

Date of last participant enrolment

Anticipated

1/12/2018

Actual

21/03/2018

Date of last data collection

Anticipated

2/02/2019

Actual

13/08/2018

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 Human Research Ethics Committee
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]

28/03/2017

Approval date [1]

09/05/2017

Ethics approval number [1]

HC17228

Summary

Brief summary

Orthokeratology (OK) lenses are specialised rigid contact lenses that are worn overnight during sleep in order to reshape the front surface of the eye to temporarily correct short-sightedness or myopia. The traditional approach to improve centration of conventional rigid contact lenses on the eye involves increasing total lens diameter. Similarly, it has been proposed that increasing the diameter of an OK lens will improve lens centration. However, this has not yet been comprehensively investigated. Therefore this research study aims to explore the influence of OK lens diameter on lens centration. This study is significant, as it will provide insight into methods to improve the fitting and efficacy of orthokeratology lenses for myopia correction.

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 60526112

Fax

p.kang@unsw.edu.au

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 60526112

Fax

p.kang@unsw.edu.au

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 60526112

Fax

p.kang@unsw.edu.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
14848	Informed consent form			p.kang@unsw.edu.au

Results publications and other study-related documents

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No additional documents have been identified.

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