None listed
Conditions
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.
Interventions
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 att
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.
Sponsors
Cylite Pty Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
Yes
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.
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)
Outcome results
None listed