Direct Comparison of SVOne Obtained Refraction to Subjective Manifest Refraction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-30

Study Completion Date

2017-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Refractive Errors

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Refraction

Refractive error measurement

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes