Clinical Investigation of the Vision-R800 Device.
1 other identifier
interventional
119
1 country
1
Brief Summary
Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and associated spectacle lenses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2019
CompletedStudy Start
First participant enrolled
November 18, 2019
CompletedFirst Posted
Study publicly available on registry
December 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedResults Posted
Study results publicly available
March 14, 2022
CompletedMarch 14, 2022
February 1, 2022
1.2 years
November 14, 2019
January 6, 2022
February 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Subjective Questionnaire Response
Patient questions of refraction preference for quickness, efficiency, comfort, and stress
at Visit 5 (final visit), up to 5 weeks
Study Arms (2)
R-Refraction
EXPERIMENTALS-Refraction
ACTIVE COMPARATORInterventions
Refraction utilizing the Vision R-800 Phoropter with resulting glasses
Refraction utilizing the standard phoropter with resulting glasses
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Indiana University Clinical Optics Research Lab
Bloomington, Indiana, 47405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to the COVID-19 pandemic this study was interrupted. Therefore, obtaining complete in-office data for some subjects was not possible. However, for all subjects possible at-home data was still obtained, as well as any in-office data that could be obtained remotely. Under allowed protocol deviation, some data was also collected in July following re-opening of the lab. We did rule out an effect of in-office as compared to remote data due to the COVID-19 pandemic.
Results Point of Contact
- Title
- Dr. Dawn Meyer
- Organization
- Indiana University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor, Associate Dean for Research, and Director of the Borish Center for Ophthalmic Research
Study Record Dates
First Submitted
November 14, 2019
First Posted
December 23, 2019
Study Start
November 18, 2019
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
March 14, 2022
Results First Posted
March 14, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share