Clinical Investigation of the Vision-R800 Device.

Phase 4CompletedNCT04208750

Pete Kollbaum, OD, PhD119 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

119

Conditions

Myopia Hyperopia Astigmatism Presbyopia

Interventions

Vision R-800 PhoropterDEVICE

Refraction utilizing the Vision R-800 Phoropter with resulting glasses

Standard PhoropterDEVICE

Refraction utilizing the standard phoropter with resulting glasses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Indiana University Clinical Optics Research Lab

Bloomington, Indiana, United States

Outcomes

Primary Outcomes

Subjective Questionnaire Response

Patient questions of refraction preference for quickness, efficiency, comfort, and stress

Time frame: at Visit 5 (final visit), up to 5 weeks

Data from ClinicalTrials.gov

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