None listed
Conditions
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.
Interventions
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.
Sponsors
Eligibility
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
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