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Trial registered on ANZCTR

Registration number

ACTRN12618000298213

Ethics application status

Approved

Date submitted

31/01/2018

Date registered

28/02/2018

Date last updated

18/01/2022

Date data sharing statement initially provided

9/07/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Evaluation of the clinical performance of multifocal orthokeratology contact lenses in young healthy adults

Scientific title

Evaluation of the short-term lens fitting performance of novel multifocal orthokeratology contact lens designs in young healthy adults

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1208-7599

Trial acronym

Linked study record

Health condition

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

Progressing mild childhood myopia

Condition category

Condition code

Eye

Diseases / disorders of the eye

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study will investigate the short-term fitting performance and corneal reshaping efficacy of multifocal orthokeratology (MFOK) contact lenses. Participants who meet eligibility requirements will take part in one, two or all three parts of the study, which will be conducted by a research team of qualified optometrists. In Part 1 the static and dynamic fitting characteristics of MFOK contact lenses with different parameters will be evaluated in a series of 15-minute lens wearing trials, over a maximum 1 hour period. Topical anaesthetic drops (0.4% oxybuprocaine) may be used to minimise discomfort after insertion and during fitting assessment of trial contact lenses. In Part 2, subjects will wear MFOK lenses in both eyes overnight only (7-8 hours per night) for up to 4 nights to evaluate lens fit in the closed eye. In Part 3, participants will wear MFOK lenses designed to correct their myopia, overnight only (7-8 hours per night) for up to 28 days, to evaluate lens fit and corneal reshaping efficacy.
All contact lenses will be made of Boston XO material (Dk 100 ISO/Fatt units). The research team will initially insert lenses into the subjects' eyes at the School of Optometry and Vision Science at the University of New South Wales. For parts 2 and 3, subjects will receive face-to-face instructions on how to insert, remove, clean and maintain the MFOK lenses so that they can safely wear the study lenses during the required wearing period. Participant compliance with the study protocol in parts 2 and 3 will be monitored by text messages from the research team every second day during the lens wearing period.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Contact lens centration, as determined by central treatment zone centration (x, y; mm) quantified from corneal topographic map

Timepoint [1]

Part 2: after 1 and 4 (primary outcome) nights of overnight lens wear
Part 3: after 1, 7, 14 and 28 (primary outcome) nights of overnight lens wear

Primary outcome [2]

Corneal topographic changes: mean change in corneal power (D) and corneal radius of curvature (mm) at different corneal locations, measured using the Medmont corneal topographer

Timepoint [2]

Part 3: after 1, 7, 14 and 28 (primary outcome) nights of overnight lens wear

Primary outcome [3]

Contact lens centration (x, y; mm) measured using high magnification clinical microscopy

Timepoint [3]

Part 1: after 15 minutes of open-eye lens wear

Secondary outcome [1]

Central refraction, using standard optometric techniques and the Shin-Nippon NVision K-5001 autorefractor

Timepoint [1]

Part 2: after 1 and 4 nights of overnight lens wear
Part 3: after 1, 7, 14 and 28 nights of overnight lens wear

Secondary outcome [2]

Ocular aberrations, using the IVS Discovery aberrometer

Timepoint [2]

Part 3: after 1, 7, 14 and 28 nights of overnight lens wear

Secondary outcome [3]

Objective peripheral refraction, in horizontal and vertical meridians, at 5 degree steps out to 30 degrees, using the Shin-Nippon NVision K-5001 autorefractor.

Timepoint [3]

Part 3: at baseline and after 28 nights of overnight lens wear

Eligibility

Key inclusion criteria

Eligibility criteria include:
- Aged 18 to 40 years
- Refractive error between +2.50 and -6.00D (parts 1 and 2); between -2.00 and -5.00D (part 3); corneal toricity <1.50D (all parts)
- No history of rigid contact lens wear
- Soft contact lens wearers willing to discontinue lens wear for at least 24 hours before participation
- Good ocular health with no history of ocular trauma or surgery
- Good general health and no medications which may influence ocular health

Minimum age

18 Years

Maximum age

40 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Potential participants will not be enrolled if they show:
- Any contraindications for rigid contact lens wear
- Anisometropia >0.75D
- Ocular pathology or active ocular surface disease
- Strabismus or amblyopia
- History of adverse reactions to eye drops or topical anaesthetics
- Not willing or able to comply with the treatment and followup schedule

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)

Allocation is not performed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Study Part 1: Due to the exploratory nature of the initial part of the study, sample size determination is not a relevant approach. Based on our prior experience with evaluating OK lens fits, we anticipate that a total of 10 participants will be sufficient for us to reach our preliminary conclusions.
Study Part 2: Using data from previous research, to conduct a study that is able to detect a 0.5mm decentration in treatment zone with the MFOK lenses, with a study power of 80% and a 5% level of statistical significance and taking into consideration a 25% drop out rate, 15 subjects will be required.
Study Part 3: Using data from previous research, to conduct a study that is able to detect a difference of 0.1 D in mid-peripheral corneal refractive power, with a study power of 0.80 at the 5% level of statistical significance and taking into consideration a 20% drop out rate, 14 subjects will be required.

Recruitment

Recruitment status

Stopped early

Data analysis

Data analysis is complete

Reason for early stopping/withdrawal

Participant recruitment difficulties
Other reasons/comments

Other reasons

Clinical trial has stopped early due to COVID-19 related delays in recruitment.

Date of first participant enrolment

Anticipated

16/07/2018

Actual

16/07/2018

Date of last participant enrolment

Anticipated

Actual

12/03/2021

Date of last data collection

Anticipated

Actual

3/06/2021

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2052 - Unsw Sydney

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

CooperVision Inc

Address [1]

5870 Stoneridge Drive, Suite 1
Pleasanton
CA 94588

Country [1]

United States of America

Primary sponsor type

Commercial sector/Industry

Name

CooperVision Inc

Address

5870 Stoneridge Drive, Suite 1, Pleasanton CA 94588

Country

United States of America

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Commercial sector/Industry

Name [1]

ProCornea Nederland BV

Address [1]

Kollergang 9, NL - 6961 LZ Eerbeek, The Netherlands

Country [1]

Netherlands

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales Human Research Ethics Committee

Ethics committee address [1]

University of New South Wales
Sydney, NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/02/2018

Approval date [1]

08/06/2018

Ethics approval number [1]

HC180050

Summary

Brief summary

Conventional orthokeratology (OK) lenses are specialised rigid contact lenses that are worn overnight during sleep in order to reshape the front surface of the eye (the cornea) to temporarily correct mild to moderate degrees of refractive error, most commonly short-sightedness or myopia. OK lenses produce subtle changes in the curvature and power of the cornea, in the order of microns of change, when worn overnight. When the lens is removed on awakening, the reshaped cornea is now able to correct the vision of the patient during the day. The reshaping effect is temporary, and the cornea returns to its original shape and power if overnight lens wear is discontinued. Conventional OK lenses produce a single central zone of altered corneal power, and are usually used for refractive correction of simple myopia.

Multifocal OK (MFOK) lenses differ from conventional OK lens designs in that the back surface design of the lens is modulated to produce a multifocal effect on corneal shape. In other words, the lens is designed to induce annular regions of alternating corneal flattening and steepening which result in concentric rings of varying corneal surface power. Contact lens designers claim that this produces a multifocal defocus effect on the neural layer of the back of the eye, or the retina, which is potentially useful for correcting presbyopia (poor reading vision), and for reducing myopic progression in children.

There are no published data on the fitting performance of MFOK lenses of differing designs. For a MFOK lens to be effective for its optical purpose, in correcting or controlling refractive errors, the corneal reshaping effect must be centred over the pupil, and the corneal reshaping induced by overnight lens wear must produce the desired changes in corneal power. The research proposed here will investigate these aspects of MFOK lens performance, to determine the potential for various designs of MFOK lens to be useful for their refractive purpose in long term use.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Helen Swarbrick

Address

School of Optometry and Vision Science
Gate 14, Barker St
Rupert Myers Building, North Wing
University of New South Wales
Sydney NSW 2052

Country

Australia

Phone

+61 2 9385 4373

Fax

+61 2 9313 6243

[email protected]

Contact person for public queries

Name

Helen Swarbrick

Address

School of Optometry and Vision Science
Gate 14, Barker St
Rupert Myers Building, North Wing
University of New South Wales
Sydney NSW 2052

Country

Australia

Phone

+61 2 9385 4373

Fax

+61 2 9313 6243

[email protected]

Contact person for scientific queries

Name

Helen Swarbrick

Address

School of Optometry and Vision Science
Gate 14, Barker St
Rupert Myers Building, North Wing
University of New South Wales
Sydney NSW 2052

Country

Australia

Phone

+61 2 9385 4373

Fax

+61 2 9313 6243

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

Commercial in-confidence

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.

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