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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

Tracking Information
First Submitted Date  ICMJE November 14, 2019
First Posted Date  ICMJE December 23, 2019
Last Update Posted Date December 23, 2019
Actual Study Start Date  ICMJE November 18, 2019
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2019)
Subjective Questionnaire Response [ Time Frame: 2 weeks ]
Subject response to questionnaire regarding experience
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Investigation of the Vision-R800 Device.
Official Title  ICMJE Clinical Investigation of the Vision-R800 Device. Understanding the Value of High Precision Refractions and Lenses to Optometrists and Patients. Phase 2
Brief Summary Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and associated spectacle lenses.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Myopia
  • Hyperopia
  • Astigmatism
  • Presbyopia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: R-Refraction
    Interventions:
    • Device: Vision R-800 Phoropter
    • Device: Standard Phoropter
  • Active Comparator: S-Refraction
    Interventions:
    • Device: Vision R-800 Phoropter
    • Device: Standard Phoropter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 19, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2020
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Dawn Meyer 8128555500 meyerd@indiana.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04208750
Other Study ID Numbers  ICMJE Kollbaum003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pete Kollbaum, OD, PhD, Indiana University
Study Sponsor  ICMJE Pete Kollbaum, OD, PhD
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Indiana University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP