Back to resultsClinical Investigation of the Vision-R800 Device.
Primary Purpose
Myopia, Hyperopia, Astigmatism
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vision R-800 Phoropter
Standard Phoropter
Sponsored by
About this trial
This is an interventional diagnostic trial for Myopia
Eligibility Criteria
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
Sites / Locations
- Indiana University Clinical Optics Research Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
R-Refraction
S-Refraction
Arm Description
Outcomes
Primary Outcome Measures
Subjective Questionnaire Response
Patient questions of refraction preference for quickness, efficiency, comfort, and stress
Secondary Outcome Measures
Full Information
NCT ID
NCT04208750
First Posted
November 14, 2019
Last Updated
February 16, 2022
Sponsor
Pete Kollbaum, OD, PhD
1. Study Identification
Unique Protocol Identification Number
NCT04208750
Brief Title
Clinical Investigation of the Vision-R800 Device.
Official Title
Clinical Investigation of the Vision-R800 Device. Understanding the Value of High Precision Refractions and Lenses to Optometrists and Patients. Phase 2
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pete Kollbaum, OD, PhD
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and associated spectacle lenses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia, Astigmatism, Presbyopia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
R-Refraction
Arm Type
Experimental
Arm Title
S-Refraction
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Vision R-800 Phoropter
Intervention Description
Refraction utilizing the Vision R-800 Phoropter with resulting glasses
Intervention Type
Device
Intervention Name(s)
Standard Phoropter
Intervention Description
Refraction utilizing the standard phoropter with resulting glasses
Primary Outcome Measure Information:
Title
Subjective Questionnaire Response
Description
Patient questions of refraction preference for quickness, efficiency, comfort, and stress
Time Frame
at Visit 5 (final visit), up to 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Indiana University Clinical Optics Research Lab
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Investigation of the Vision-R800 Device.
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