Clinical Investigation of the Vision-R800 Device.

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

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Key information

Conditions

Myopia Astigmatism Eye Diseases Hyperopia Presbyopia Refractive Errors

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Indiana University Clinical Optics Research Lab

Bloomington, Indiana, 47405, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vision R-800 Phoropter

Device

Refraction utilizing the Vision R-800 Phoropter with resulting glasses

Standard Phoropter

Device

Refraction utilizing the standard phoropter with resulting glasses

Primary outcomes

Subjective Questionnaire Response

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

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

Sponsors and collaborators

Lead sponsor

Pete Kollbaum, OD, PhD

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Dec 23, 2019
Registry last updated: Mar 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed