Demonstrate that refraction measurements from the device agree with refraction measurements from a phoropter within clinically meaningful limits.
The primary purpose of this study is to attain scientific objective evidence to support the VisionCheck Indications for Use by demonstrating that refraction measurements from the device agree with refraction measurements from a phoropter within clinically meaningful limits. The Indications for Use are: "The EyeQue VisionCheck automated subjective refraction system provides an estimate of sphere, cylinder, and axis measurements of the eye" Furthermore, the purpose of this study is to attain scientific objective evidence regarding the precision of the VisionCheck device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
156
Automated subjective refraction system provides estimates of sphere, cylinder, and axis measurements of the eye.
Standard of care, ophthalmic testing device, used by eye care professionals to measure the refractive error of the eye and determine prescription.
Assess agreement between the VisionCheck refraction measurement and a phoropter (standard of care) refraction measurement.
Bland-Altman limits of agreement (LoA) for within-eye differences between refraction measurements of sphere, cylinder, and axis obtained from VisionCheck and the subjective phoropter
Time frame: 3 months
Assess total variability and variance components for between- replicates (repeatability) and between-device/operator while adjusting for between-participant and between-site variability.
Percent coefficient of variation (%CV) and standard deviation (SD) of refraction measurement outputs in the form of sphere, cylinder, and axis obtained from VisionCheck
Time frame: 3 months
Assess improvement in visual acuity brought forth by the VisionCheck refraction measurement.
95% upper prediction limit of improvement in visual acuity from refraction measurements obtained from VisionCheck compared to best corrected visual acuity from the subjective phoropter
Time frame: 3 months
Assess the safety of the VisionCheck device.
Adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), serious adverse device effects (SADEs), anticipated and unanticipated serious adverse device effects (ASADEs and USADEs, respectively)
Time frame: 3 months
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