Direct Comparison of SVOne Obtained Refraction to Subjective Manifest Refraction

Smart Vision Labs

Status: Unknown

Conditions: Refractive Errors

Treatments: Diagnostic Test: Refraction

Study type: Observational

Funder types: Industry

Identifiers

NCT03222661

SVOne01

Details and patient eligibility

About

The purpose of the study is to compare the final glasses prescription based on refraction obtained with SVOne device to the final prescription obtained via subjective manifest refraction.

Full description

Uncorrected refractive error is the leading cause of vision impairment and the second leading cause of blindness worldwide, affecting 1 in 90 individuals (1). In the US population approximately 14 million individuals aged 12 years or older have visual impairment (defined as distance visual acuity of 20/50 or worse), of which more than 11 million individuals (2) could have their vision improved to 20/40 or better with refractive correction.

Uncorrected refractive error impacts all aspects of life, including, but not limited to, loss of employment opportunities, inability to care for family, and inability to receive an education. SVOne is smartphone-based autorefractor, powered by wavefront aberrometry, due to its portability and accuracy it presents as an effective and accessible method of detecting refractive error and dispensing spectacles for better vision (3).

In this study, for each patient, a single clinician will determine final prescription through manifest refraction, while a different clinician will determine final prescription using SVOne exam protocol. Sphere, cylinder and axis will be converted to power vectors and compared by linear regression analysis.

Enrollment: 200 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects must be 12 (under 18 with parental consent) years of age and older up to 65 years of age.
• No known ocular pathology from previous clinical exams that may limit best corrected visual acuity.

Exclusion criteria

• Refractive error greater than +/- 14.00 diopters, or astigmatism greater than -7.00 diopters.
• Known ocular (corneal, lenticular, vitreal, or retinal) pathology that may limit BCVA.
• Best corrected visual acuity with spectacles of 20/25 or worse.
• Any previous surgical or laser procedures that may limit BCVA
• 11 years of age and younger