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Trial registered on ANZCTR
Registration number
ACTRN12624001493538
Ethics application status
Approved
Date submitted
29/11/2024
Date registered
20/12/2024
Date last updated
16/06/2025
Date data sharing statement initially provided
20/12/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Testing the effect of optical designs on short-term changes in eye length and vision
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Scientific title
Testing the effect of optical designs using adaptive optics on the short-term axial length of the eye and vision quality in healthy young participants
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Secondary ID [1]
313495
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Nil known
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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
335917
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Condition category
Condition code
Eye
332508
332508
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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
The eye rapidly responds to imposed blur by changing choroidal thickness (a vascular layer at the back of the eye) and eye length (choroidal thickness changes move the retina forward and backward to influence eye length). Such changes in eye length vary according to the magnitude, type and location of the imposed blur (ie. the optical design). These changes in choroidal thickness and eye length are very small (typically 5-15 microns) compared to the length of the eye (23 mm) and have no measurable impact on vision.
This study involves the use of adaptive optics (digital optics) to create optical designs for participants to view a movie on a small TV screen. Measurements of eye length are taken before and after 30 minutes of viewing a movie on the screen with each of the tested optical designs (measured on different days). The small temporary changes in eye length in response to the optical designs are thought to be predictive of longer-term eye growth (over years). The quality of vision is also tested through the adaptive optics system with each optical design.
Eight optical designs will be tested, each on a separate day (to avoid carry-over effects) and at the same time of day (to avoid diurnal effects).
The eight optical designs are: (1) +3 D defocus, (2) central +7 D defocus and a non-coaxial peripheral zone crossing the optical axis, (3) a high order oscillation in power from plano to +4 D, (4) a high order oscillation in power from plano to +6 D, (5) a high order oscillation in power from plano to +8 D, (6) a saw-tooth oscillation in power from plano to +4 D and (7) a saw-tooth oscillation in power from plano to +6 D and a control condition (8) with clear vision (no optical blur).
Repeated measures study design with all participants being tested with all optical designs.
The participant views movies of their choice on a black and white high-definition micro-display screen through the adaptive optics system.
Participants sit in a head rest (chin and forehead rest) during the experiment viewing through the adaptive optics system. The movie displayed on the micro-display is projected through the adaptive optics system and subtends a visual angle of about 6 degrees, which means that its size is similar to a mobile phone at arm's length.
The research scientist monitors the participants alignment in the adaptive optics system periodically throughout the 30 minutes of movie viewing to ensure alignment of the optics with the participants pupil (optical aperture of the eye).
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Intervention code [1]
330070
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Treatment: Devices
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Comparator / control treatment
This study involves the use of adaptive optics (digital optics) to create optical designs for participants to view a movie on a small TV screen. Measurements of eye length are taken before and after 30 minutes of viewing a movie on the screen with each of the tested optical designs (measured on different days).
The control treatment is to provide the participant with clear vision (no optical blur) and to undertake an identical protocol, measuring eye length before and after 30 minutes, watching a movie on the TV screen.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in axial length of the eye after 30 minutes
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Assessment method [1]
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A scan biometry of the eye using Lenstar LS900
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Timepoint [1]
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Baseline and after 30 minutes exposure to blur condition
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Secondary outcome [1]
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Visual acuity with the test optical designs
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Assessment method [1]
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A tumbling E letter chart is used. It is presented on a micro-display monitor in high contrast. The participant makes a 4 alternate choice to respond if the letter is facing up/down/left/right and a software program varies the letter size to reach a threshold measurement. Result is presented as log of the minimum angle of resolution (logMAR).
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Timepoint [1]
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Immediately when viewing through the optical design
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Eligibility
Key inclusion criteria
Participants will be recruited who meet the following inclusion criteria:
1. Subjects must read, understand and sign the informed consent form
2. Subjects must be between 18 and 39 years (inclusive) of age to ensure active and sustained accommodation response
3. Best corrected visual acuity of at least 0 logMAR in each eye
4. No significant ocular disease or functional vision loss (e.g. peripheral visual field defect)
5. Astigmatism of 0.50 DC or less to eliminate the need for astigmatic correction during the experiment
6. Best sphere refractive error between 0.00 and -5.00 DS
7. Steady and accurate fixation (no significant eye movement anomalies).
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Minimum age
18
Years
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Maximum age
39
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion Criteria after Screening:
1. Currently pregnant
2. Any systemic disease (e.g., Sjögren’s Syndrome), significant allergies, infectious disease (e.g., hepatitis, tuberculosis), COVID-19, or other diseases, by subject’s self-report, which are known to potentially interfere with participation in the study.
3. Use of systemic medications (e.g., chronic steroid use) that are known to have side effects in eyes or vision and/or interfere with participation in the study.
4. Any current use of ocular medication.
5. Recent temporary or long-term use (within 21 days from enrolment) of topical agents with anti-muscarinic properties. This includes but is not limited to scopolamine, pirenzepine, tropicamide, cyclopentolate, atropine and homatropine (anti-muscarinics can cause the choroid to thicken).
6. Any planned (during the course of the study) ocular surgery (e.g., LASIK).
7. History of myopia control treatment or participation in any prior myopia control clinical study with an optical intervention for more than 2 weeks. This includes but is not limited to orthokeratology treatment or use of other ophthalmic devices (e.g., bifocal, multifocal spectacles/contact lenses or other novel contact or spectacles lenses). This also includes light therapy for myopia control such as red or blue light.
8. No regular use of nicotine (cigarettes, vapes, patches etc).
9. No alcohol or caffeine intake within 2 hrs prior to a testing session.
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Data will be tested for normality and then appropriate parametric or non-parametric tests will be applied.
Repeated measures ANOVA (two-way) will be used to test main effects of blur condition (the optical designs) and time of exposure.
The independent variable will be axial length change.
The within-subjects factors will be type of blur condition (type of optical design) and time of exposure to blur (0 and 30 mins).
If the main effects are significant in the ANOVA, Bonferroni corrected post-hoc tests will be used to further explore the data.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
6/01/2025
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Actual
24/03/2025
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Date of last participant enrolment
Anticipated
30/04/2025
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Actual
2/06/2025
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Date of last data collection
Anticipated
30/06/2025
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Actual
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Sample size
Target
15
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Accrual to date
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Final
15
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Johnson and Johnson Vision Care
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Address [1]
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Country [1]
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United States of America
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Primary sponsor type
University
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Name
Queensland University of Technology
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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]
320281
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Address [1]
320281
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Country [1]
320281
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Queensland University of Technology University Human Research Ethics Committee
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Ethics committee address [1]
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https://www.qut.edu.au/research/why-qut/ethics-and-integrity
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
316616
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Approval date [1]
316616
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15/07/2024
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Ethics approval number [1]
316616
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8452
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Summary
Brief summary
The research questions this project seeks to answer are whether the optical power designs developed by Johnson and Johnson Vision Care (JJVC) for use in contact lenses have the ability to shorten the eye and how much those same designs affect vision levels. This will be a prospective, interventional data collection study comparing the relative effectiveness of the various designs that are tested. It is hypothesized that by varying the optical design and the amount of blur imposed on the eye, small temporary changes in the length of the eye can be measured. Short-term changes in eye length (30 minutes) are thought to be a biomarker for the longer-term growth of the eye and can therefore be used as a predictive tool for whether the specific design will slow or increase myopia progression in longer term clinical trials (over years).
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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 Michael Collins
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Address
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Optometry and Vision Science, QUT, O Block, Victoria Park Rd, Kelvin Grove, 4059, QLD
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Country
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Australia
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Phone
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+61 413 246913
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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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Michael Collins
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Address
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Optometry and Vision Science, QUT, O Block, Victoria Park Rd, Kelvin Grove, 4059, QLD
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Country
138431
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Australia
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Phone
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+61 413 246913
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Fax
138431
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Email
138431
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[email protected]
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Contact person for scientific queries
Name
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Michael Collins
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Address
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Optometry and Vision Science, QUT, O Block, Victoria Park Rd, Kelvin Grove, 4059, QLD
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Country
138432
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Australia
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Phone
138432
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+61 413 246913
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Fax
138432
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Email
138432
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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
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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