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.

Not Applicable

Completed

• Conditions: ormal eyes; Cataracts; Refractive errors; Retinal diseases; Normal eyes; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12622000771752
• Lead Sponsor: Cylite Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-30
• Study Completion: 2023-02-28
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 164

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 ErrorsSevere 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 DiseaseEyes 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)

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 between HP-OCT and 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. corneal topographic maps) via assessing the agreement between HP-OCT and Pentacam HR.[ Measurements obtained at each scan; agreement calculated at statistical analysis stage.];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.[ Measurements obtained at each scan; agreement calculated at statistical analysis stage.]

Secondary Outcome Measures

Name	Time	Method
Additional primary outcome - Determine the precision (repeatability and reproducibility) of the biometric measurements of HP-OCT (e.g. axial length, anterior chamber depth).[ Measurements obtained at each scan; precision calculated at statistical analysis stage.];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.[ Retinal images obtained at each retina scan; images graded at image reading center.]