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

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

Study Overview

• Status: Completed
• Conditions: Presbyopia; Astigmatism; Myopia; Hyperopia
• Intervention / Treatment: Device: Vision R-800 Phoropter; Device: Standard Phoropter

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Indiana University Clinical Optics Research Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: R-Refraction	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
Active Comparator: S-Refraction	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Questionnaire Response	Patient questions of refraction preference for quickness, efficiency, comfort, and stress	at Visit 5 (final visit), up to 5 weeks

Collaborators and Investigators

• Sponsor: Pete Kollbaum, OD, PhD

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Astigmatism; Hyperopia
• Other Study ID Numbers: Kollbaum003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No