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NCT04208750

Clinical Investigation of the Vision-R800 Device.

Completed Phase 4 Results posted Last updated 14 March 2022
What this trial tests

Phase 4 trial testing Vision R-800 Phoropter in Myopia in 119 participants. Completed in 1 February 2021.

Timeline
18 November 2019
Primary endpoint
1 February 2021
1 February 2021

Quick facts

Lead sponsorPete Kollbaum, OD, PhD
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposediagnostic
Enrollment119
Start date18 November 2019
Primary completion1 February 2021
Estimated completion1 February 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Pete Kollbaum, OD, PhD

Who can join

Adults 18 to 70, any sex, with Myopia or Hyperopia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Subjective Questionnaire Response Primary · at Visit 5 (final visit), up to 5 weeks

Patient questions of refraction preference for quickness, efficiency, comfort, and stress

Quickness
GroupValue95% CI
R-Refraction Then S-Refraction22
S-Refraction Then R-Refraction32
R-Refraction Then S-Refraction5
S-Refraction Then R-Refraction3
R-Refraction Then S-Refraction15
S-Refraction Then R-Refraction11
Efficiency
GroupValue95% CI
R-Refraction Then S-Refraction25
S-Refraction Then R-Refraction26
R-Refraction Then S-Refraction4
S-Refraction Then R-Refraction4
R-Refraction Then S-Refraction13
S-Refraction Then R-Refraction16
Comfort
GroupValue95% CI
R-Refraction Then S-Refraction26
S-Refraction Then R-Refraction21
R-Refraction Then S-Refraction5
S-Refraction Then R-Refraction6
R-Refraction Then S-Refraction11
S-Refraction Then R-Refraction19
Stress
GroupValue95% CI
R-Refraction Then S-Refraction16
S-Refraction Then R-Refraction19
R-Refraction Then S-Refraction7
S-Refraction Then R-Refraction10
R-Refraction Then S-Refraction19
S-Refraction Then R-Refraction17

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Clinical Comparison of High-resolution and Standard Refractions and Prescriptions.
    Meyer D, Rickert M, Reed O, Joret P, et al · · 2023 · PMID 37861987 · DOI 10.1097/opx.0000000000002076

Verify or expand the search:

Other recruiting trials for Myopia

Currently open trials in the same condition.

Other Pete Kollbaum, OD, PhD trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04208750.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing