Pediatric Refraction With SVOne Autorefractor

• Conditions: Ocular Refraction

• Registration Number: NCT02559271
• Lead Sponsor: Smart Vision Labs

Brief Summary

The study is used to verify the accuracy and repeatability of Smart Vision Labs Refractor in a pediatric population (between 5 and 16 years of age).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Status Verified: 2015-09
• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-22
• Last Update Submitted: 2015-09-22
• Study First Posted: 2015-09-24
• Last Update Posted: 2015-09-24
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. healthy children
2. ages 5-16 year
3. male and female

Exclusion Criteria

1. presence of ocular disease
2. refractive surgery
3. amblyopia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sphere refraction measurement	up to 6 months	the outcome include sphere refraction (in diopter) measurements by using both Smart Vision Labs autorefractor and subjective refraction
Cylinder refraction measurement	up to 6 months	the outcome include cylinder refraction (in diopter) measurements by using both Smart Vision Labs autorefractor and subjective refraction
difference between two Sphere refraction measurements on the same patient	up to 6 months	the outcome include the difference (in diopter) between two Sphere refraction measurements on the same patient by using smart vision labs autorefractor
difference between two cylinder refraction measurements on the same patient	up to 6 months	the outcome include the difference (in diopter) between two cylinder refraction measurements on the same patient by using smart vision labs autorefractor

Trial Locations

Locations (1)

SUNY/College of Optometry; 🇺🇸 New York, New York, United States