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Trial registered on ANZCTR


Registration number
ACTRN12625000029493
Ethics application status
Approved
Date submitted
28/11/2024
Date registered
15/01/2025
Date last updated
15/01/2025
Date data sharing statement initially provided
15/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the performance of a non-contact and non-invasive Hyperparallel optical coherence tomography device in measuring retinal layers of normal eyes and eyes with diseases.
Scientific title
Validation of Cylite’s Hyperparallel OCT (HP-OCT) Retinal Layer Segmentation in Healthy and Diseased Eyes
Secondary ID [1] 313477 0
HCT-CL-SOP-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucomatous eyes 335887 0
Diseased retina 335888 0
Condition category
Condition code
Eye 332472 332472 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A total of 90 eyes (30 healthy (normal) eyes, 30 glaucomatous eyes and 30 diseased retina eyes) will be analysed within this study. A wide refractive range of normal participants will be sought with particular focus on recruiting a number of high myopes (>5 D). In order to achieve this, it is anticipated that a total of 100 participants aged 18 years and over will be screened for this study. Only one eye of an individual will be measured if they meet the inclusion criteria. Following the study screening, if both eyes of an individual meet the inclusion criteria, the eye to be tested will be determined from a randomisation list using a Latin Square design. The instrument testing order for each participant will also be randomised.

After informed consent process and screening examination, each eligible subject will undergo the following scans.

On Cylite's HP-OCT,

• One valid biometry scan will be taken.
• Three valid retinal images will then be taken for two separate posterior eye modes.
- The first employs a central fixation target and focusses on the macula
- The second utilises a nasal fixation target focusing on the optic nerve head.
• An additional scan will be captured using the macula scanning protocol with a varied working distance. For example, the additional image may be taken in positive delay when the three original images may have been captured in negative delay.

On Spectralis,

• Three valid horizontal macula scans will be collected. The macula scans will be volumetric and will match the parameters of the HP-OCT as closely as possible.
• Two optic nerve head scanning protocols will be implemented on the Spectralis SD-OCT instrument.
- Firstly, 3 valid radial circle maps will be captured which consist of 24 radial scans and three circle scans of varying diameter.
- Secondly, 3 optic nerve head volume scans will be captured.

All scans are non-contact and non-invasive. The HP-OCT and Spectralis are both imaging OCT devices. They are not applied to a subject, rather a subject is imaged on these devices by placing their chin on a chin rest and the forehead on a forehead rest and a non-invasive image is taken. Both devices utilize spectral domain (SD-OCT) OCT technology, the key different between the two devices is the HP-OCT includes micro-optics to create a parallel grid of 1008 beamlets to capture an image whereas the Spectralis uses just one scanning beam. All eligible subjects will receive the same required scans on all the devices as described above. All scans are completed in a single imaging session. Imaging time will be no more than 20min at each device, this time allows for the subject to sit back and take the time they need in between the imaging.

The repeatability of HP-OCT measurements will be characterised and the agreement of the measurements between HP-OCT and Spectralis will be studied for the following segmentation parameters.

• Macular - ETDRS thickness maps (centred at the fovea and oriented horizontally) each ETDRS quadrant for the mean (+/-SD) retinal nerve fibre layer (RNFL), combined ganglion cell and inner plexiform layer (GCL+IPL), inner nuclear layer (INL), outer plexiform layer (OPL), outer nuclear layer (ONL), retinal pigment epithelium (RPE) as well as total retinal thickness.

• Optic Disc - Optic nerve head retinal nerve fibre layer thicknesses within a peripapillary zone of 3.45 mm diameter; Average RNFL thickness as well as quadrant-specific (superior, inferior, temporal and nasal) RNFL thicknesses; Macula and GC-IPL thicknesses within an elliptical annulus area around the fovea; Optic nerve head parameters including cup-disc ratios (vertical, horizontal and mean) as well as minimum rim-width (superior, inferior, nasal, temporal and overall).

The user interface of each device provides the user with quality indicators to guide the user on the scan quality. These indicators are outlined within the user manual of each device and will make up part of the training for the user prior to the study commencing, The different scan locations (e.g. macular) needed for this study are also outlined in the user interface and will again be addressed during the training to ensure the scan protocols are met.
Intervention code [1] 330056 0
Diagnosis / Prognosis
Comparator / control treatment
No comparison between subject groups will be studied.

For each subject group, measurements taken using the HP-OCT will be compared to measurements taken using the Spectralis,

The Spectralis is an Optical Coherence Tomography (OCT), a non-invasive imaging device that uses light waves to take cross-sectional pictures of the retina. The participants will place their chin on the chin rest and forehead on the forehead rest and will see a target within the device to focus on. The user will engage with the user interface and acquire non-invasive scans of the subject.
Control group
Active

Outcomes
Primary outcome [1] 340018 0
Determine the repeatability of HP-OCT in retinal segmentation measurements.
This is a composite primary outcome.
The retinal layers that will be measured are: ILM (internal limiting membrane), RNFL (retinal nerve fibre layer), GCL (ganglion cell layer) and IPL (inner plexiform layer), INL (inner nuclear layer, OPL (outer nuclear layer) and RPE (retina pigment epithelium).
Timepoint [1] 340018 0
Measurements obtained at each scan; repeatability calculated at statistical analysis stage.

For the HP-OCT 3 retinal images will be taken for two separate scan locations (i.e. macular scan and optic nerve head scan), 6 scans in total. For the Spectralis 3 macular scan will be collected and as the optic nerve head has two scanning protocols, 3 of each protocol will be taken, in total 9 Spectralis scans will be taken.
Secondary outcome [1] 442350 0
Investigate the accuracy of HP-OCT in retinal measurements via assessing the agreement of HP-OCT with Spectralis.
Timepoint [1] 442350 0
Three scans will be taken at each of the device, with each of the scanning protocols within the same assessment session.

Eligibility
Key inclusion criteria
o Participants with normal healthy eyes apart from specific recruitment categories
o Participants will have best corrected visual acuity (logMAR 0.30, 6/12 or better in each eye), unless they fall into the specific recruitment categories of glaucoma or diseased retina
o Approximately equal numbers of male and female participants will be sought

To assess for Glaucomatous and Diseased retina eyes the following tests will be performed during screening:
o Case history will be taken to record medical and ocular history and concomitant medications
o Anterior eye examination - slit lamp biomicroscopy including cataract grading (LOCSIII) and angle assessment
o Posterior pole eye examination using slit-lamp biomicroscopy to observe and record the health of the optic nerve and macula. Retinal images will also be captured using a standard retinal camera which will be used as part of the subject qualification and data analysis.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
o No history of ocular injury in the past 12 weeks
o No use of lubrication within an hour of testing
o No contact lens wear on the testing day
o No active ocular infection or inflammation
o No previous ocular surgery apart from LASIK or cataract surgery
o No strabismus
o No ocular pathology (anterior or posterior) which is likely to affect the participants ability to fixate on the instrument’s fixation target (and therefore affect their ability to have high quality measurements obtained)

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/01/2025
Actual
Date of last participant enrolment
Anticipated
21/03/2025
Actual
Date of last data collection
Anticipated
21/03/2025
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317919 0
Commercial sector/Industry
Name [1] 317919 0
Cylite Pty Ltd
Country [1] 317919 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cylite Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 320272 0
None
Name [1] 320272 0
Address [1] 320272 0
Country [1] 320272 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316604 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [1] 316604 0
https://www.qut.edu.au/research/why-qut/ethics-and-integrity
Ethics committee country [1] 316604 0
Australia
Date submitted for ethics approval [1] 316604 0
Approval date [1] 316604 0
07/11/2024
Ethics approval number [1] 316604 0

Summary
Brief summary
The proposed study will be a prospective, observational, non-intervention study that will collect clinical ocular measurements from a range of participants including those with healthy and diseased retinas to allow comparison of the Cylite Hyperparallel Optical Coherence Tomographer (HP-OCT) with the Heidelberg Spectralis Spectral-Domain Optical Coherence Tomographer (SD-OCT). The main objective of this study is to evaluate the validity and repeatability of the retinal layer segmentation of images acquired with the HP-OCT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138386 0
Prof Michael Collins
Address 138386 0
School of Optometry and Vision Science Queensland University of Technology 2 George St, Brisbane City QLD 4000
Country 138386 0
Australia
Phone 138386 0
+61731385702
Fax 138386 0
Email 138386 0
[email protected]
Contact person for public queries
Name 138387 0
Catherine Foster
Address 138387 0
School of Optometry and Vision Science Queensland University of Technology 2 George St, Brisbane City QLD 4000
Country 138387 0
Australia
Phone 138387 0
+61731385731
Fax 138387 0
Email 138387 0
[email protected]
Contact person for scientific queries
Name 138388 0
Hamish McNeill
Address 138388 0
School of Optometry and Vision Science Queensland University of Technology 2 George St, Brisbane City QLD 4000
Country 138388 0
Australia
Phone 138388 0
+61731385705
Fax 138388 0
Email 138388 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

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No documents have been uploaded by study researchers.

Documents added automatically
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