Pediatric Refraction With SVOne Autorefractor

September 22, 2015 updated by: Smart Vision Labs
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).

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10036
        • Recruiting
        • SUNY/College of Optometry
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

pediatric population, between 5 and 16 years of age

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sphere refraction measurement
Time Frame: up to 6 months
the outcome include sphere refraction (in diopter) measurements by using both Smart Vision Labs autorefractor and subjective refraction
up to 6 months
Cylinder refraction measurement
Time Frame: up to 6 months
the outcome include cylinder refraction (in diopter) measurements by using both Smart Vision Labs autorefractor and subjective refraction
up to 6 months
difference between two Sphere refraction measurements on the same patient
Time Frame: 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
up to 6 months
difference between two cylinder refraction measurements on the same patient
Time Frame: 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
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smart Vision Labs

Collaborators

State University of New York College of Optometry

Investigators

  • Principal Investigator: Kenneth Ciuffreda, PH.D, State University of New York College of Optometry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

September 21, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Estimate)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • Aug/25/2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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