Clinical trial NCT03222661: Direct Comparison of SVOne Obtained Refraction to Subjective Manifest Refraction
Official title: Direct Comparison of SVOne Obtained Refraction to Subjective Manifest Refraction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Refractive Errors
Lead sponsor: Smart Vision Labs
Sponsor class: INDUSTRY
First posted: 2017-07-19
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population with refractive error between -14.00 to +14.00 diopter of spherical error and astigmatism up to -7.00 diopters.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sphere, cylinder and axis measurement for each patient
timeFrame: 4 months
measure: Comparison of two measurements on the same patient
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Dr. Rosa Pham & Associates
state: Texas
Study officials:
References:
citation: Naidoo KS, Leasher J, Bourne RR, Flaxman SR, Jonas JB, Keeffe J, Limburg H, Pesudovs K, Price H, White RA, Wong TY, Taylor HR, Resnikoff S; Vision Loss Expert Group of the Global Burden of Disease Study. Global Vision Impairment and Blindness Due to Uncorrected Refractive Error, 1990-2010. Optom Vis Sci. 2016 Mar;93(3):227-34. doi: 10.1097/OPX.0000000000000796.
citation: Vitale S, Cotch MF, Sperduto RD. Prevalence of visual impairment in the United States. JAMA. 2006 May 10;295(18):2158-63. doi: 10.1001/jama.295.18.2158.
citation: Ciuffreda KJ, Rosenfield M. Evaluation of the SVOne: A Handheld, Smartphone-Based Autorefractor. Optom Vis Sci. 2015 Dec;92(12):1133-9. doi: 10.1097/OPX.0000000000000726.