NCT03502863

Clinical Study to Evaluate Effectiveness of Digital Refraction

A Prospective Clinical Study to Evaluate the Effectiveness of Digital Refraction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Visibly · Industry
• Sex: All
• Age: 22 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Prospective, comparative, randomized, non-masked clinical study to compare the a digital refraction with LogMAR VA testing utilizing trial lenses, to standard manual refraction using a Phoropter, and LogMAR VA testing, in accuracy of visual acuity measurement.

Detailed description

A digital refraction tool is a device meant to measure visual acuity and to subjectively measure refractive value for a patient's eye for the conditions of myopia and astigmatism. It is intended for adults aged 22 to 55 years that have no prior correction with up to 3.00 diopters (D) of myopia and up to 2.00 D of astigmatism, or those with prior correction up to 10.00 D of myopia and require an over-refraction of no more than 2.75 D. LogMAR (ETDRS) chart to measure visual acuity. The manual manifest refraction is performed by an eyecare specialist using a phoropter. The LogMAR Visual Acuity chart is used to measure visual acuity. The manual refraction will be used in this study for obtaining the refractive error of each eye.

Conditions

• Myopia
• Astigmatism

Interventions

Type	Name	Description
DEVICE	Digital refraction	A web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone.
OTHER	Manual Refraction	Manual refraction and ETDRS chart

Timeline

• Start date: 2018-04-19
• Primary completion: 2018-07-06
• Completion: 2018-07-06
• First posted: 2018-04-19
• Last updated: 2018-10-26

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study