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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
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Scientific title
Assessment of axial length changes in human eyes and wearability with different types of multifocal spectacle lenses
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Secondary ID [1]
314380
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
myopia
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Condition category
Condition code
Eye
333761
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0
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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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,
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Intervention code [1]
330994
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Treatment: Devices
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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)
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Control group
Active
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Outcomes
Primary outcome [1]
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Wearability comfort satisfaction score
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Assessment method [1]
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Wearability assessment score (Scale 1-10)
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Timepoint [1]
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15 minutes after the lens wear at each of six different visits.
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Secondary outcome [1]
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Axial length changes after 60 minutes of lens wear at each of six different visits.
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Assessment method [1]
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The axial length will be assessed using LENSTAR LS 900 (Haag-Streit, Switzerland) with measurements in units of millimetre.
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Timepoint [1]
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Baseline and 60 minutes after the lens wear at each of six different visits.
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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.
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Minimum age
18
Years
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Maximum age
30
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Use of rigid contact lens wear
• Any prior myopia control treatment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization using a randomization table created by computer software.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
23/09/2024
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Date of last participant enrolment
Anticipated
30/06/2025
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Actual
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Date of last data collection
Anticipated
31/07/2025
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Actual
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Sample size
Target
20
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Accrual to date
16
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
318899
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Other
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Name [1]
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Brien Holden Vision Institute
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Other
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Name
Brien Holden Vision Institute
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
321363
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Country [1]
321363
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The University of New South Wales Research Ethics Committee A
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Ethics committee address [1]
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https://research.unsw.edu.au/research-ethics-and-compliance-support-recs
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
317514
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14/05/2024
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Approval date [1]
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26/07/2024
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Ethics approval number [1]
317514
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6712
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Summary
Brief summary
• To assess changes in axial length of myopic eyes to short-term (60 mins) wear of multifocal and myopia control spectacle lenses. • To assess the wearability to short-term wear of multifocal and myopia control spectacle lenses. Study Hypothesis: The changes in length of an eye when wearing prototype multifocal lenses are no different than when wearing commercially available lenses for controlling shortsightedness. Prototype multifocal lenses provides the same visual comfort and wearability as commercially available lenses for controlling shortsightedness.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Arthur Ho
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Address
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Level 4, Brien Holden Vision Institute, Rupert Myers Building, North Wing, Gate 14, UNSW Barker St,Kensington 2052, NSW
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Country
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Australia
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Phone
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+61418868124
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Arthur Ho
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Address
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Level 4, Brien Holden Vision Institute, Rupert Myers Building, North Wing, Gate 14, UNSW Barker St,Kensington 2052, NSW
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Country
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Australia
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Phone
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+61418868124
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Arthur Ho
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Address
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Level 4, Brien Holden Vision Institute, Rupert Myers Building, North Wing, Gate 14, UNSW Barker St,Kensington 2052, NSW
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Country
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Australia
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Phone
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+61418868124
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Fax
141292
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
N/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.
Download to PDF