Ocular RefractionNCT02559271
Pediatric Refraction With SVOne Autorefractor
An observational study of Ocular Refraction, run by Smart Vision Labs at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Refraction
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: pediatric population, between 5 and 16 years of age
Who may be able to join
- healthy children
- ages 5-16 year
- male and female
Who cannot join
- presence of ocular disease
- refractive surgery
- amblyopia
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
SUNY/College of Optometry
New York, New York, 10036
Kenneth Ciuffreda, O.D, PH.D, 212-938-5765, kciuffreda@sunyopt.edu
About this study
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).
- Conditions
- Ocular Refraction
What is being measured
The primary outcome is the main question the study is designed to answer.
Sphere refraction measurement
the outcome include sphere refraction (in diopter) measurements by using both Smart Vision Labs autorefractor and subjective refraction
Measured: 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
Measured: 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
Measured: 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
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular RefractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smart Vision Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- State University of New York College of Optometry
- Responsible party
- Sponsor
- Investigators
- Kenneth Ciuffreda, PH.D, Principal investigator, State University of New York College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559271
- Sponsor's protocol ID
- Aug/25/2015
- Status last verified
- Sep 2015
- First submitted
- 21 Sep 2015
- Last updated
- 24 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Refraction With SVOne Autorefractor
- ClinicalTrials.gov ID
- NCT02559271
- Acronym / sponsor ID
- Aug/25/2015
- Conditions
- Ocular Refraction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Smart Vision LabsIndustry (pharma, biotech, devices)
- Collaborators
- State University of New York College of Optometry
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- pediatric population, between 5 and 16 years of age
Key inclusion criteria (3 listed)
- healthy children
- ages 5-16 year
- male and female
Key exclusion criteria (3 listed)
- presence of ocular disease
- refractive surgery
- amblyopia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Ciuffreda, PH.D principal investigator
State University of New York College of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Refraction, run by Smart Vision Labs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenneth Ciuffreda, PH.D (212-938-5765, kciuffreda@sunyopt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sphere refraction measurement (time frame: up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2015.