Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000585426
Ethics application status
Approved
Date submitted
13/05/2025
Date registered
5/06/2025
Date last updated
5/06/2025
Date data sharing statement initially provided
5/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of axial length changes in human eyes and wearability with different types of multifocal spectacle lenses
Scientific title
Assessment of axial length changes in human eyes and wearability with different types of multifocal spectacle lenses
Secondary ID [1] 314380 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myopia 337380 0
Condition category
Condition code
Eye 333761 333761 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
• Multifocal spectacle Lens type 3: Clear central zone (up to 9mm);peripheral zone with alternating rings of +5.0D and plano power presenting simultaneous defocus (Coaxial design)
• Multifocal spectacle Lens type 4 : Clear central zone (up to 9mm); peripheral zone with alternating rings of -5.0D and plano power presenting simultaneous defocus (Coaxial design)
• Multifocal spectacle Lens type 5: Clear central zone (up to 9mm); peripheral zone with alternating rings of +5.0D and plano power presenting simultaneous defocus (Non-coaxial design)
• Multifocal spectacle Lens type 6: Clear central zone (up to 9mm); peripheral zone with alternating rings of -5.0D and plano power presenting simultaneous defocus (Non-co-axial design)

This is a prospective, randomized, non-dispensing, cross-over short-term wear (60 mins) clinical trial

The participants will be assigned to wear each of the lens type once during the study. Each of the lenses will be worn for 60 minutes once per day, Each participant will wear 6 different lenses (2 control and 4 intervention lenses) on six different days with a minimum washout period of 24 hours between study visits.

The participant will wear these lenses over 60 minutes under the supervision of a qualified optometrist,


Intervention code [1] 330994 0
Treatment: Devices
Comparator / control treatment
• Spectacle lens Type 1: Single vision spectacle lens of plano power
• Multifocal spectacle Lens Type 2: Commercially available lens for Myopia control (MiYOSMART®, HOYA Corporation)
Control group
Active

Outcomes
Primary outcome [1] 341346 0
Wearability comfort satisfaction score
Timepoint [1] 341346 0
15 minutes after the lens wear at each of six different visits.
Secondary outcome [1] 447201 0
Axial length changes after 60 minutes of lens wear at each of six different visits.
Timepoint [1] 447201 0
Baseline and 60 minutes after the lens wear at each of six different visits.

Eligibility
Key inclusion criteria
• Age ranging from 18-30 years;
• Non-cycloplegic spherical equivalent refractive error ranging from -0.75D to –5.00D;
• Best corrected visual acuity of 20/30or better in both eyes;
• Normal ocular health (No ocular disease)
• No history of ocular surgery;
• No manifest squint or intermittent tropias;
• Astigmatism less than 1.00 D;
• Anisometropia of not more than 1.00 D;
• Normal general health.
• No current use of ocular or systemic medications excepting use of lubricating or anti-allergic eye drops.
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Use of rigid contact lens wear
• Any prior myopia control treatment

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)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization using a randomization table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/09/2024
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
20
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318899 0
Other
Name [1] 318899 0
Brien Holden Vision Institute
Country [1] 318899 0
Australia
Primary sponsor type
Other
Name
Brien Holden Vision Institute
Address
Country
Australia
Secondary sponsor category [1] 321363 0
None
Name [1] 321363 0
Address [1] 321363 0
Country [1] 321363 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317514 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 317514 0
Ethics committee country [1] 317514 0
Australia
Date submitted for ethics approval [1] 317514 0
14/05/2024
Approval date [1] 317514 0
26/07/2024
Ethics approval number [1] 317514 0
6712

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

Contacts
Principal investigator
Name 141290 0
Prof Arthur Ho
Address 141290 0
Level 4, Brien Holden Vision Institute, Rupert Myers Building, North Wing, Gate 14, UNSW Barker St,Kensington 2052, NSW
Country 141290 0
Australia
Phone 141290 0
+61418868124
Fax 141290 0
Email 141290 0
[email protected]
Contact person for public queries
Name 141291 0
Arthur Ho
Address 141291 0
Level 4, Brien Holden Vision Institute, Rupert Myers Building, North Wing, Gate 14, UNSW Barker St,Kensington 2052, NSW
Country 141291 0
Australia
Phone 141291 0
+61418868124
Fax 141291 0
Email 141291 0
[email protected]
Contact person for scientific queries
Name 141292 0
Arthur Ho
Address 141292 0
Level 4, Brien Holden Vision Institute, Rupert Myers Building, North Wing, Gate 14, UNSW Barker St,Kensington 2052, NSW
Country 141292 0
Australia
Phone 141292 0
+61418868124
Fax 141292 0
Email 141292 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocolN/A   Available on request 3. Zeeshan_Wearability_Clinical Trial Protocol for medical device_ClearVersion4.docx


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.