Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000771752
Ethics application status
Approved
Date submitted
27/04/2022
Date registered
30/05/2022
Date last updated
1/02/2023
Date data sharing statement initially provided
30/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the performance (accuracy, precision) of a non-contact and non-invasive optical coherence tomography device in imaging and measuring normal eyes and eyes with diseases.
Scientific title
Evaluation of Measurement Agreement and Precision and Fundus Visualization Using Hyperparallel Optical Coherence Tomography (HP-OCT) in Normal Eyes and Eyes With Diseases.
Secondary ID [1] 306757 0
HCT-CL-SOP-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal eyes 325767 0
Cataracts 326390 0
Refractive errors 326391 0
Retinal diseases 326392 0
Condition category
Condition code
Eye 323103 323103 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 4 groups, i.e. normal, cataract, significant refractive errors and retinal diseases. The study includes two sub-studies. For sub-study 1, each subject of the normal, cataract or significant refractive errors group will be scanned by HP-OCT and 3 comparative ophthalmic diagnostic devices (Carl Zeiss IOLMaster 700, Ocuclus Pentacam HR, Carl Zeiss Cirrus HD-OCT 5000) for 3 acceptable biometric scans/measurements in a maximum of 7 attempts on each device. The precision of HP-OCT measurement will be characterised for each of the 4 groups. The HP-OCT measurements will also be compared with the comparator devices for agreement of accuracy within each of the 4 groups. In sub-study 2, each subject of the normal and retinal diseases group will be scanned by HP-OCT and 1 comparative ophthalmic diagnostic device (Carl Zeiss Cirrus HD-OCT 5000) for 1 acceptable retinal image in a maximum of 3 attempts on each device. The image quality of HP-OCT will be graded and compared with the comparative device within each of the 2 groups. All scans are non-contact and non-invasive. The scans will be performed and assessed by qualified ophthalmologists, optometrists and/or orthoptists at three ophthalmic clinics. All scans on a subject will take place in one subject 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 hour.
Intervention code [1] 323207 0
Diagnosis / Prognosis
Comparator / control treatment
No control group - No comparison between subject groups will be studied.

Biometric measurements taken using the HP-OCT device will be compared to measurements taken using the IOLMaster 700, Pentacam HR and Cirrus HD-OCT 5000 devices. Retinal images obtained by HP-OCT device will be graded and compared to those taken by Cirrus HD-OCT 5000 device.
Control group
Active

Outcomes
Primary outcome [1] 330876 0
Investigate the accuracy of HP-OCT in biometric measurements (e.g. axial length, anterior chamber depth) via assessing the agreement between HP-OCT and IOLMaster 700.
Timepoint [1] 330876 0
Measurements obtained at each scan; agreement calculated at the statistical analysis stage.
Primary outcome [2] 330877 0
Investigate the accuracy of HP-OCT in biometric measurements (e.g. corneal topographic maps) via assessing the agreement between HP-OCT and Pentacam HR.
Timepoint [2] 330877 0
Measurements obtained at each scan; agreement calculated at statistical analysis stage.
Primary outcome [3] 331422 0
Investigate the accuracy of HP-OCT in biometric measurements (e.g. epithelial thickness) via assessing the agreement between HP-OCT and Cirrus HD-OCT 5000.
Timepoint [3] 331422 0
Measurements obtained at each scan; agreement calculated at statistical analysis stage.
Secondary outcome [1] 407896 0
Additional primary outcome - Determine the precision (repeatability and reproducibility) of the biometric measurements of HP-OCT (e.g. axial length, anterior chamber depth).
Timepoint [1] 407896 0
Measurements obtained at each scan; precision calculated at statistical analysis stage.
Secondary outcome [2] 409834 0
Additional primary outcome - Investigate the reliability of HP-OCT in generating retinal images to aid qualitative diagnosis, via image grading between HP-OCT and Cirrus HD-OCT 5000.
Timepoint [2] 409834 0
Retinal images obtained at each retina scan; images graded at image reading center.

Eligibility
Key inclusion criteria
1. Eligible for at least one of the Eye Populations as described below.
Normal: Phakic eyes without cataracts, corneal, retinal disease, or prior laser vision correction (LVC); with best corrected visual acuity (BCDVA) 20/20 or better, but not meeting Subject Group C myopia/hyperopia criteria.

Cataract: Cataract with an Age-Related Eye Disease Study (AREDS) grade of 1 to 4 or a Lens Opacity Classification System III (LOCS III) grade of 2 to 6, excluding those with significant refractive error defined as myopia greater than or equal to -6 D, hyperopia greater than or equal to +5.25 D, and/or prior LVC (laser-assisted in situ keratomileusis (LASIK), small-incision lenticule extraction (SMILE) or photorefractive keratectomy (PRK)) that corrected for the aforementioned refractive error. Eyes with other anterior segment abnormalities, retina disease, or glaucoma can be included.

Significant Refractive Errors Severe myopia (greater than or equal to -6 D), severe hyperopia (greater than or equal to +5.25 D), or prior LVC (LASIK, SMILE or PRK) that corrected for the aforementioned refractive error, excluding those with an AREDS grade of 1 to 4 or a LOCS III grade of 2 to 6. Eyes with other anterior segment abnormalities, retina disease or glaucoma can be included.

Retinal Disease Eyes diagnosed with retinal diseases as confirmed at the study visit or prior visits including but not limited to, age-related macular degeneration, diabetic retinopathy, diabetic macular edema, macular hole, epiretinal membrane. Subjects who have abnormal anterior segment or glaucoma, or had prior Ophthalmic surgery, such as cataract removal and intraocular lens implant can be included.

2. Aged between 18 and 85 years.

3. No history of rigid contact lens wear for at least 2 weeks. Soft lenses, if worn, should be removed at least one hour prior to the measurement.

4. Able and willing to give consent and follow study instructions.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Enrolled in previous HP-OCT clinical studies

2. Rigid contact lens wear during past two weeks

3. Active ocular infection or inflammation

4. Pregnant women

5. Unsuitable for the study due to other medical condition as per Principal Investigator's determination (e.g. patient is unable to place their chin on the chinrest of any device)

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/06/2022
Actual
8/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
170
Accrual to date
154
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 311097 0
Commercial sector/Industry
Name [1] 311097 0
Cylite Pty Ltd
Country [1] 311097 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cylite Pty Ltd
Address
7/45 Normanby Rd, Notting Hill, VIC 3168
Country
Australia
Secondary sponsor category [1] 312429 0
None
Name [1] 312429 0
Address [1] 312429 0
Country [1] 312429 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310630 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 310630 0
123 Glen Osmond Road, Eastwood, South Australia 5063.
Ethics committee country [1] 310630 0
Australia
Date submitted for ethics approval [1] 310630 0
Approval date [1] 310630 0
25/01/2022
Ethics approval number [1] 310630 0

Summary
Brief summary
This clinical investigation is targeted at collecting further clinical effectiveness and safety evidence of HP-OCT (Hyperparallel OCT®) 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.

This investigation is composed of two sub-studies. The objective of Sub-study 1 is to (1) determine the precision (repeatability and reproducibility) of HP-OCT in biometric measurements, and (2) investigate the agreement of biometric measurements between the HP-OCT instrument and 3 state-of-the-art comparative devices. Sub-study 2 aims on investigating the reliability of the HP-OCT in generating retinal images to aid qualitative diagnosis. This investigation is a three-site study based on nested design, involving one unit of each of the 4 instruments (HP-OCT and 3 comparative devices) at each of the three sites (12 devices in total). The target enrolment is approximately 150 participants who will be divided into 4 subject/pathological eye populations and go through the non-contact non-invasive ocular scans using the HP-OCT and the comparative devices in a single site visit. All the information, data and images collected are de-identified for communication, analysis, and report. The retinal images obtained for Sub-study 2 will be sent to an image reading centre for qualitative image grading by three independent and masked image graders. The biometric measurements (Sub-study 1) and the retinal image grading results (Sub-study 2) will then be analysed statistically following the pre-specified protocol before the conclusion is drawn and reported in the clinical study report.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118322 0
Prof John Grigg
Address 118322 0
Gordon Eye Surgery, 2/741 Pacific Hwy, Gordon, NSW 2072
Country 118322 0
Australia
Phone 118322 0
+61 2 9932 6308
Fax 118322 0
Email 118322 0
john.grigg@sydney.edu.au
Contact person for public queries
Name 118323 0
Ms Donna Glenn
Address 118323 0
Gordon Eye Surgery, 2/741 Pacific Hwy, Gordon, NSW 2072
Country 118323 0
Australia
Phone 118323 0
+61 2 9418 1488
Fax 118323 0
Email 118323 0
d.glenn@gordoneye.com.au
Contact person for scientific queries
Name 118324 0
Prof John Grigg
Address 118324 0
Gordon Eye Surgery, 2/741 Pacific Hwy, Gordon, NSW 2072
Country 118324 0
Australia
Phone 118324 0
+61 2 9932 6308
Fax 118324 0
Email 118324 0
john.grigg@sydney.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.