Clinical Investigation of the Vision-R800 Device.

Pete Kollbaum, OD, PhD

Status and phase: Completed; Phase 4

Conditions: Myopia; Astigmatism; Presbyopia; Hyperopia

Treatments: Device: Vision R-800 Phoropter; Device: Standard Phoropter

Study type: Interventional

Funder types: Other

Identifiers

NCT04208750

Kollbaum003

Details and patient eligibility

About

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

Enrollment: 119 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• current adaptated progressive addition lens wearer, if bifocal lens required
• wearable pair of glasses < 2 years old
• wear glasses at least 6 hours per day

Exclusion criteria

• Eye Disease with an impact on visual acuity or binocular vision abnormalities (by self-report)
• Formal training in optometry, vision science or in the eyecare field

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

R-Refraction

Experimental group

Treatment:

Device: Vision R-800 Phoropter

Device: Standard Phoropter

S-Refraction

Active Comparator group

Treatment:

Device: Vision R-800 Phoropter

Device: Standard Phoropter