Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001493538
Ethics application status
Approved
Date submitted
29/11/2024
Date registered
20/12/2024
Date last updated
20/12/2024
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
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
Secondary ID [1] 313495 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myopia 335917 0
Condition category
Condition code
Eye 332508 332508 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
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.
Seven 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 seven 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.
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).
Intervention code [1] 330070 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 340030 0
Change in axial length of the eye after 30 minutes
Timepoint [1] 340030 0
Baseline and after 30 minutes exposure to blur condition
Secondary outcome [1] 442391 0
Visual acuity with the test optical designs
Timepoint [1] 442391 0
Immediately when viewing through the optical design

Eligibility
Key inclusion criteria
Participants must have good vision and healthy eyes, participants with any level of refractive error are permitted as long as this is optically corrected. Refractive errors can include myopia, hyperopia or astigmatism.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current myopia control treatment
Systemic diseases such as Sjögren’s Syndrome affecting tears, or chronic steroid use (eg rheumatoid arthritis), or vascular disease (affecting the choroid).
Eye diseases such as dry eye, amblyopia affecting visual response of the retina, strabismus affecting fixation, or nystagmus affecting fixation.

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)
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
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/01/2025
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317933 0
Commercial sector/Industry
Name [1] 317933 0
Johnson and Johnson Vision Care
Country [1] 317933 0
United States of America
Primary sponsor type
University
Name
Queensland University of Technology
Address
Country
Australia
Secondary sponsor category [1] 320281 0
None
Name [1] 320281 0
Address [1] 320281 0
Country [1] 320281 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316616 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [1] 316616 0
Ethics committee country [1] 316616 0
Australia
Date submitted for ethics approval [1] 316616 0
Approval date [1] 316616 0
15/07/2024
Ethics approval number [1] 316616 0
8452

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

Contacts
Principal investigator
Name 138430 0
Prof Michael Collins
Address 138430 0
Optometry and Vision Science, QUT, O Block, Victoria Park Rd, Kelvin Grove, 4059, QLD
Country 138430 0
Australia
Phone 138430 0
+61 413 246913
Fax 138430 0
Email 138430 0
m.collins@qut.edu.au
Contact person for public queries
Name 138431 0
Michael Collins
Address 138431 0
Optometry and Vision Science, QUT, O Block, Victoria Park Rd, Kelvin Grove, 4059, QLD
Country 138431 0
Australia
Phone 138431 0
+61 413 246913
Fax 138431 0
Email 138431 0
m.collins@qut.edu.au
Contact person for scientific queries
Name 138432 0
Michael Collins
Address 138432 0
Optometry and Vision Science, QUT, O Block, Victoria Park Rd, Kelvin Grove, 4059, QLD
Country 138432 0
Australia
Phone 138432 0
+61 413 246913
Fax 138432 0
Email 138432 0
m.collins@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.