NCT04208750

Clinical Investigation of the Vision-R800 Device.

Clinical Investigation of the Vision-R800 Device. Understanding the Value of High Precision Refractions and Lenses to Optometrists and Patients. Phase 2

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Pete Kollbaum, OD, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and associated spectacle lenses.

Conditions

• Myopia
• Hyperopia
• Astigmatism
• Presbyopia

Interventions

Type	Name	Description
DEVICE	Vision R-800 Phoropter	Refraction utilizing the Vision R-800 Phoropter with resulting glasses
DEVICE	Standard Phoropter	Refraction utilizing the standard phoropter with resulting glasses

Timeline

• Start date: 2019-11-18
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2019-12-23
• Last updated: 2022-03-14
• Results posted: 2022-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study