Phase 4
N=119
Clinical Investigation of the Vision-R800 Device.
Myopia · Hyperopia · Astigmatism · Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT04208750 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Subjective Questionnaire Response — 22; 32; 5; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vision R-800 Phoropter (Device); Standard Phoropter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pete Kollbaum, OD, PhD
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Questionnaire Response |
22; 32; 5; 3; 15; 11 | — |
Summary
Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and associated spectacle lenses.
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
Data sourced from ClinicalTrials.gov (NCT04208750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.