Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000251628
Ethics application status
Approved
Date submitted
6/02/2023
Date registered
8/03/2023
Date last updated
8/03/2023
Date data sharing statement initially provided
8/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the performance (accuracy, precision) of a new non-contact and non-invasive hyperparallel optical coherence tomography device in imaging and measuring normal eyes and eyes with diseases.
Scientific title
Evaluation of biometric measurement agreement and precision of a HP-OCT (Hyperparallel Optical Coherence Tomography) device in normal eyes and eyes with diseases.
Secondary ID [1] 308872 0
CYC-CL-SOP-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataracts 328864 0
Pseudophakic (monofocal or toric interocular lens (IOL)) 328865 0
Post-refractive surgery (phakic or pseudophakic with monofocal or toric IOL) 328866 0
Phakic <30 years with no history of refractive surgery or ocular disease including cataract, corneal cylinder <2 D 328867 0
Phakic <30 years with no history of refractive surgery or ocular disease, corneal cylinder >2 D 328868 0
Dry eye 328869 0
Condition category
Condition code
Eye 325862 325862 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
In this study, subjects (eyes) will be recruited and divided into 6 groups, i.e. cataract, pseudophakic (monofocal or toric IOL), post-refractive surgery (phakic or pseudophakic with monofocal or toric IOL), phakic <30 years with no history of refractive surgery or ocular disease including cataract, corneal cylinder <2 D, phakic <30 years with no history of refractive surgery or ocular disease, corneal cylinder >2 D, and dry eye.

After informed consent process and screening examination, for each eligible subject,

• 3 acceptable scans/measurements/tests for each modality of biometry, wavefront, topography and tear film assessment will be obtained on HP-OCT+;
• 3 acceptable biometry scan/measurements will be obtained from HP-OCT and IOLMaster 700;
• 3 acceptable retinal images will be also obtained from HP-OCT+ and HP-OCT;
• 3 acceptable scans/measurements for each scan type of wavefront, axial length and topography will be obtained on Innoveyes Sightmap,
• 3 acceptable tear film tests will be performed on Keratograph 5M

All scans are non-contact and non-invasive. All eligible subjects will receive the same required scans on all the devices as described above. The order of the instrument testing and the eye to be tested first (right versus left) will be randomised for each individual participant using a Latin Square design. The scans will be performed and assessed for acceptability by qualified ophthalmologists, optometrists and/or orthoptists at the study site following the respective device user manual. All scans on a subject will take place in one visit. Each scan attempt is not expected to take more than 1 minute. The total scan time on a subject is expected to be less than 1.5 hour.

The repeatability of HP-OCT+ measurements will be characterised. The scan/measurement data of the first acceptable scan will be also compared between HP-OCT+ and the other four comparative instruments.

• The biometric data will be compared with HP-OCT, IOLMaster 700 and Innoveyes Sightmap;
• The wavefront and topography data will be compared with Innoveyes Sightmap;
• The tear film tests data will be compared with Keratograph 5M; and
• The retinal images will be compared with HP-OCT.
Intervention code [1] 325323 0
Diagnosis / Prognosis
Comparator / control treatment
No control group - No comparison between subject groups will be studied.

For each subject group, biometric measurements taken using the HP-OCT+ device will be compared to measurements taken using the HP-OCT, HP-OCT, IOLMaster 700 and Innoveyes Sightmap device. Wavefront data obtained by HP-OCT+ device will be compared to those taken by Innoveyes Sightmap. Tear Film assessment results of HP-OCT+ will be compared to those taken by Keratograph 5M.
Control group
Active

Outcomes
Primary outcome [1] 333700 0
Investigate the accuracy of HP-OCT+ in biometric measurements (e.g. axial length, anterior chamber depth) via assessing the agreement of HP-OCT+ with HP-OCT.
Timepoint [1] 333700 0
Measurements obtained at each scan; agreement calculated at the statistical analysis stage.
Primary outcome [2] 333701 0
Investigate the accuracy of HP-OCT+ in biometric measurements (e.g. axial length, anterior chamber depth) via assessing the agreement of HP-OCT+ with IOLMaster 700.
Timepoint [2] 333701 0
Measurements obtained at each scan; agreement calculated at the statistical analysis stage.
Primary outcome [3] 333702 0
Investigate the accuracy of HP-OCT+ in biometric measurements (e.g. axial length, anterior chamber depth) via assessing the agreement of HP-OCT+ with Innoveyes Sightmap.
Timepoint [3] 333702 0
Measurements obtained at each scan; agreement calculated at the statistical analysis stage.
Secondary outcome [1] 417988 0
Additional primary outcome - Investigate the accuracy of HP-OCT+ in wavefront aberrations and corneal topographic measurements via assessing the agreement of HP-OCT+ and Innoveyes Sightmap.
Timepoint [1] 417988 0
Measurements obtained at each scan; agreement calculated at the statistical analysis stage.
Secondary outcome [2] 418481 0
Additional primary outcome - Investigate the accuracy of HP-OCT+ in tear film test results (e.g. tear break-up time, noninvasive tear break-up time) via assessing the agreement of HP-OCT+ with Keratograph 5M.
Timepoint [2] 418481 0
Measurements obtained at each scan; agreement calculated at the statistical analysis stage.
Secondary outcome [3] 418482 0
Additional primary outcome - Determine the repeatability of HP-OCT+ measurements (e.g. axial length, anterior chamber depth).
Timepoint [3] 418482 0
Measurements obtained at each scan; repeatability calculated at statistical analysis stage.

Eligibility
Key inclusion criteria
o Age greater than or equal to 18 years
o Participants with normal health eyes apart from specific recruitment categories
o Participants will have best corrected visual acuity (logMAR 0.00, 6/6 or better in each eye), unless they fall into the specific recruitment categories of cataract, intraocular lens or post-refractive surgery
Minimum age
18 Years
Maximum age
85 Years
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 ocular medications on the day of testing
o No use of lubrication within an hour of testing
o No soft contact lens wear on the testing day
o No rigid contact lens wearers
o No active ocular infection or inflammation
o No eyelid pathology that may interfere with blinking including ptosis, entropian, ectropian, blepharitis, lid margin disease or chalazia
o No history of eyelid surgery
o No corneal conditions and diseases that may impair the topography pattern reflection such as keratoconus, central corneal scar or pterygia
o No ocular posterior segment pathology which may affect their 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
15/03/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 313092 0
Commercial sector/Industry
Name [1] 313092 0
Cylite Pty Ltd
Country [1] 313092 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cylite Pty Ltd
Address
300 Wellington Road, Mulgrave, VIC 3170
Country
Australia
Secondary sponsor category [1] 314790 0
None
Name [1] 314790 0
Address [1] 314790 0
Country [1] 314790 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312337 0
University Human Research Ethics Committee of Queensland University of Technology
Ethics committee address [1] 312337 0
PO Box: OREI
Office of Research Ethics and Integrity
GPO Box 2434
QLD 4000
Ethics committee country [1] 312337 0
Australia
Date submitted for ethics approval [1] 312337 0
Approval date [1] 312337 0
04/11/2022
Ethics approval number [1] 312337 0
6233

Summary
Brief summary
This clinical investigation is targeted at collecting clinical effectiveness and safety evidence of HP-OCT+ (Hyperparallel OCT®) instrument in visualising and measuring anterior and posterior ocular structures/parameters. It is hypothesised that the HP-OCT+ is not inferior to, or less safe than the current standard devices utilised to measure anterior and posterior ocular structures/parameters.

In this investigation, about 70 subjects (eyes) will be recruited and divided into 6 groups, i.e. cataract, pseudophakic (monofocal or toric IOL), post-refractive surgery (phakic or pseudophakic with monofocal or toric IOL), phakic <30 years with no history of refractive surgery or ocular disease including cataract, corneal cylinder <2 D, phakic <30 years with no history of refractive surgery or ocular disease, corneal cylinder >2 D, and dry eye. The subject will be scanned/measured on HP-OCT+ instrument and the other four comparative instruments (HP-OCT, IOLMaster 700, Keratograph 5M and Innoveyes Sightmap). The measurement data obtained from different HP-OCT+ modalities (biometry, topography, wavefront, tear film test) will be then compared with the corresponding measurement from the comparative instruments, to investigate the agreement of HP-OCT+ with the comparative instruments. The repeatability of these HP-OCT+ measurements will also be determined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124306 0
Prof Michael Collins
Address 124306 0
School of Optometry and Vision Science
Queensland University of Technology
2 George St, Brisbane City QLD 4000
Country 124306 0
Australia
Phone 124306 0
+61731385702
Fax 124306 0
Email 124306 0
m.collins@qut.edu.au
Contact person for public queries
Name 124307 0
Ms Catherine Foster
Address 124307 0
School of Optometry and Vision Science
Queensland University of Technology
2 George St, Brisbane City QLD 4000
Country 124307 0
Australia
Phone 124307 0
+61731385731
Fax 124307 0
Email 124307 0
c.foster@qut.edu.au
Contact person for scientific queries
Name 124308 0
Dr Hamish McNeill
Address 124308 0
School of Optometry and Vision Science
Queensland University of Technology
2 George St, Brisbane City QLD 4000
Country 124308 0
Australia
Phone 124308 0
+61731385705
Fax 124308 0
Email 124308 0
hamish.mcneill@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.