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Trial registered on ANZCTR


Registration number
ACTRN12625000013460
Ethics application status
Approved
Date submitted
29/11/2024
Date registered
9/01/2025
Date last updated
9/01/2025
Date data sharing statement initially provided
9/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Optical coherence tomography imaging of the back of the eyes of healthy participants to develop automated measurement software
Scientific title
Swept source optical coherence tomography angiography imaging of the posterior eye of participants with healthy eyes to develop automated segmentation software
Secondary ID [1] 313496 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia is the health condition which will ultimately be the focus of the outcomes of this study. 335918 0
Condition category
Condition code
Eye 332509 332509 0 0
Normal eye development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The choroid and layers of the posterior eye will be imaged using the Triton swept source OCT angiography instrument in participants with healthy eyes to allow development of automated segmentation software. The software delineates the thickness of individual tissue layers in the eye. The software can be later used in the development of myopia interventions to slow eye growth.
The images provide a cross section of the eye tissues.
The scanning protocols to be used include:
• Horizontal line scans (9 mm width) – 6 times
• Five-line cross scan (6 mm width) – 6 times
• Radial scan pattern (6 mm width) – 6 times
• Angiography scans – 3D Macula (3 mm volumetric) – 6 times

A typical scanning protocol involves:
• Adjusting the participant’s head/eye position in the Triton headrest until they can see the Triton’s internal fixation target
• Instructing the participant to continue watching the fixation target during the scans and the likely length of the scan time
• Instructing the participant to blink twice and then waiting 2-3 seconds before the scan commences to ensure a high-quality tear distribution and optimal scan quality
• Instructing the participant to sit back from the instrument and relax before commencing the next set of scans

The scanning protocol typically requires a few minutes per scan and there are four different scanning protocols.
There will be a single visit with total duration of about 60 minutes.
Intervention code [1] 330071 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340031 0
The primary outcome of the image analysis will include the thickness of the choroid between the boundaries of the retinal pigment epithelium (RPE) and chorio-scleral interface (CSI).
Timepoint [1] 340031 0
Scans of the posterior eye will be conducted at one 60 minute visit.
Primary outcome [2] 340274 0
The perfusion (blood flow) of the choroid will be measured.
Timepoint [2] 340274 0
Scans of the posterior eye will be conducted at one 60 minute visit.
Secondary outcome [1] 442397 0
Nil
Timepoint [1] 442397 0
Nil

Eligibility
Key inclusion criteria
Good vision
Healthy eyes
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The presence of cataracts will interfere with the optical coherence tomography scans and participants with cataracts will be excluded.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The development of deep learning (artificial intelligence) software for segmenting optical coherence tomography images requires a set of reference images for "training" the software. We will acquire reference images from 40 participants. Based on previous work in our laboratory and numerous other published papers in this field, a dataset of at least 20 reference images is sufficient to allow the development of accurate segmentation software (ie. better than 99% accuracy in tissue layer detection).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/01/2025
Actual
Date of last participant enrolment
Anticipated
11/04/2025
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317934 0
Commercial sector/Industry
Name [1] 317934 0
Johnson and Johnson Vision Care
Country [1] 317934 0
United States of America
Primary sponsor type
University
Name
Queensland University of Technology
Address
Country
Australia
Secondary sponsor category [1] 320282 0
None
Name [1] 320282 0
Address [1] 320282 0
Country [1] 320282 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316617 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [1] 316617 0
https://www.qut.edu.au/research/why-qut/ethics-and-integrity
Ethics committee country [1] 316617 0
Australia
Date submitted for ethics approval [1] 316617 0
05/03/2024
Approval date [1] 316617 0
11/03/2024
Ethics approval number [1] 316617 0
8211

Summary
Brief summary
Swept source optical coherence tomographers (SS-OCTs) provide high resolution images of the eye and have an enhanced depth of focus (greater scanning depth in tissue) compared to conventional (spectral domain) OCTs. These additional features allow for blood flow characteristics in the retina and choroid to be quantified (OCT Angiography) without the use of any additional dyes, drugs or contact with the eye. This is a prospective data collection study which aims to capture clinical data of the choroid with the Triton swept source OCT including angiography. In order to enhance the vascular characteristics analysis, software tools will later be developed by the project team.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138434 0
Prof Michael Collins
Address 138434 0
Optometry and Vision Science, QUT, O Block, Victoria Park Rd, Kelvin Grove, 4059, QLD
Country 138434 0
Australia
Phone 138434 0
+61 413 246913
Fax 138434 0
Email 138434 0
[email protected]
Contact person for public queries
Name 138435 0
Michael Collins
Address 138435 0
Optometry and Vision Science, QUT, O Block, Victoria Park Rd, Kelvin Grove, 4059, QLD
Country 138435 0
Australia
Phone 138435 0
+61 413 246913
Fax 138435 0
Email 138435 0
[email protected]
Contact person for scientific queries
Name 138436 0
Michael Collins
Address 138436 0
Optometry and Vision Science, QUT, O Block, Victoria Park Rd, Kelvin Grove, 4059, QLD
Country 138436 0
Australia
Phone 138436 0
+61 413 246913
Fax 138436 0
Email 138436 0
[email protected]

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.