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.

Not Applicable

• Conditions: Cataracts; 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; Dry eye; Eye - Diseases / disorders of the eye; Pseudophakic (monofocal or toric interocular lens (IOL)); Post-refractive surgery (phakic or pseudophakic with monofocal or toric IOL)

• Registration Number: ACTRN12623000251628
• Lead Sponsor: Cylite Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-08
• Last Update Posted: 20 March 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

oAge greater than or equal to 18 years
oParticipants with normal health eyes apart from specific recruitment categories
oParticipants 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

oNo history of ocular injury in the past 12 weeks
oNo use of ocular medications on the day of testing
oNo use of lubrication within an hour of testing
oNo soft contact lens wear on the testing day
oNo rigid contact lens wearers
oNo active ocular infection or inflammation
oNo eyelid pathology that may interfere with blinking including ptosis, entropian, ectropian, blepharitis, lid margin disease or chalazia
oNo history of eyelid surgery
oNo corneal conditions and diseases that may impair the topography pattern reflection such as keratoconus, central corneal scar or pterygia
oNo 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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[Measurements obtained at each scan; agreement calculated at the statistical analysis stage.];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.[Measurements obtained at each scan; agreement calculated at the statistical analysis stage.];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.[Measurements obtained at each scan; agreement calculated at the statistical analysis stage.]

Secondary Outcome Measures

Name	Time	Method
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.[Measurements obtained at each scan; agreement calculated at the statistical analysis stage.];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.[Measurements obtained at each scan; agreement calculated at the statistical analysis stage.];Additional primary outcome - Determine the repeatability of HP-OCT+ measurements (e.g. axial length, anterior chamber depth).[Measurements obtained at each scan; repeatability calculated at statistical analysis stage.]