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NCT03929588

Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye

Completed NA Results posted Last updated 24 March 2022
What this trial tests

NA trial testing Hand-held device supported by a mobile application in Refractive Errors in 230 participants. Completed in 31 March 2020.

Timeline
7 May 2019
Primary endpoint
31 March 2020
31 March 2020

Quick facts

Lead sponsorEyeQue Corp.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingdouble
Primary purposediagnostic
Enrollment230
Start date7 May 2019
Primary completion31 March 2020
Estimated completion31 March 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

EyeQue Corp.

Who can join

Adults 30 to 65, any sex, with Refractive Errors or Astigmatism. 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.

BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years Primary · Through study completion, an average of 5 months

Best-corrected visual acuity (BVCA) utilizing refraction results using the handheld device with supporting application will be compared to standard manual refraction methods (using a phoropter) for the age stratum 45 through 65 years.

BCVA handheld device
GroupValue95% CI
All Participants0.060.04 – 0.08
BCVA manual refraction
GroupValue95% CI
All Participants0.020 – 0.04
BCVA automated refraction
GroupValue95% CI
All Participants0.030.01 – 0.05

Sponsor's own description

Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor.

Publications & conference data

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

  1. End Points, Collection, Processing, and Time: Four Key Elements to Consider When Planning for Use of Handheld Devices in a Drug Development Setting.
    Pradhan V, Heatherington AC, Bhattacharya I. · · 2020 · PMID 31944268 · DOI 10.1002/cpt.1740

Verify or expand the search:

Other recruiting trials for Refractive Errors

Currently open trials in the same condition.

Other EyeQue Corp. 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/NCT03929588.

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