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Clinical Investigation of the Vision-R800 Device.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208750
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Pete Kollbaum, OD, PhD, Indiana University

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

Condition or disease Intervention/treatment Phase
Myopia Hyperopia Astigmatism Presbyopia Device: Vision R-800 Phoropter Device: Standard Phoropter Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Investigation of the Vision-R800 Device. Understanding the Value of High Precision Refractions and Lenses to Optometrists and Patients. Phase 2
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Subjective Questionnaire Response [ Time Frame: 2 weeks ]
    Subject response to questionnaire regarding experience



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208750


Contacts
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Contact: Dawn Meyer 8128555500 meyerd@indiana.edu

Locations
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United States, Indiana
Indiana University Clinical Optics Research Lab Recruiting
Bloomington, Indiana, United States, 47405
Contact: Dawn Meyer    812-855-5500    CORL@indiana.edu   
Sponsors and Collaborators
Pete Kollbaum, OD, PhD
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Responsible Party: Pete Kollbaum, OD, PhD, Associate Professor, Associate Dean for Research, and Director of the Borish Center for Ophthalmic Research, Indiana University
ClinicalTrials.gov Identifier: NCT04208750    
Other Study ID Numbers: Kollbaum003
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Astigmatism
Presbyopia
Hyperopia
Refractive Errors
Eye Diseases