NCT02559271

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 24, 2015

Status Verified

September 1, 2015

Enrollment Period

4 months

First QC Date

September 21, 2015

Last Update Submit

September 22, 2015

Conditions

Ocular Refraction

Outcome Measures

Primary Outcomes (4)

  • Sphere refraction measurement

    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

    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

    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

    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

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

pediatric population, between 5 and 16 years of age

You may qualify if:

  • healthy children
  • ages 5-16 year
  • male and female

You may not qualify if:

  • presence of ocular disease
  • refractive surgery
  • amblyopia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY/College of Optometry

New York, New York, 10036, United States

RECRUITING

Study Officials

  • Kenneth Ciuffreda, PH.D

    State University of New York College of Optometry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Ciuffreda, PH.D

CONTACT

212-938-5765kciuffreda@sunyopt.edu

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 24, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 24, 2015

Record last verified: 2015-09

Locations

US(1)