NCT06044688

EyeQue VisionCheck 510(k) Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: EyeQue Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Demonstrate that refraction measurements from the device agree with refraction measurements from a phoropter within clinically meaningful limits.

Detailed description

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.

Conditions

• Refractive Errors
• Astigmatism

Interventions

Type	Name	Description
DEVICE	EyeQue VisionCheck	Automated subjective refraction system provides estimates of sphere, cylinder, and axis measurements of the eye.
DEVICE	Phoropter	Standard of care, ophthalmic testing device, used by eye care professionals to measure the refractive error of the eye and determine prescription.

Timeline

• Start date: 2023-10-01
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2023-09-21
• Last updated: 2023-09-21

Regulatory

• FDA-regulated device study