Vision DisordersNCT03479021
SPOT Vision Screening
An observational study of Vision Disorders, run by Children's Hospital Colorado at 1 site in United States.
Trial summary
The purpose of this protocol is to determine if the Welch-Allyn Spot Vision Screener (SPOT) is effective at detecting various risk factors for poor vision in developmentally delayed children. These children have a higher percentage of vision disorders than the average population. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Vision Disorders
- What is being tested?
- Welch-Allyn Spot Vision Screener
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2017to 31 May 2019
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The children have various disabilities or delays to include: Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), chromosomal abnormalities such as Down Syndrome, Cerebral Palsy (CP), and mental retardation (MR).
Who may be able to join
- child over 4 months of age social, behavioral, physical, or other handicap unable to complete age-appropriate vision screening
Who cannot join
- glaucoma post intraocular surgery microphthalmia other serious eye disorder inability to complete SPOT screener
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045-7106
Kyle Phillips, 702-777-0524, kyle.phillips@childrenscolorado.org
About this study
Official title: Accuracy of Welch Allyn Spot™ Vision Screener to Detect Amblyogenic Factors in Developmentally Delayed Children
The purpose of this protocol is to determine if the Welch-Allyn Spot Vision Screener (SPOT) is effective at detecting various risk factors for poor vision in developmentally delayed children. These children have a higher percentage of vision disorders than the average population. The SPOT screen itself takes about six seconds to complete. It produces a photograph of the eye and a print out with amount of hyperopia, myopia, astigmatism and pupil size. The subject will have three SPOT screens around the time of their standard of care eye exam. The data obtained from the three SPOT screens will be compared among themselves for accuracy and to the findings of the clinical eye exam.
- Conditions
- Vision Disorders
- Being tested
- Welch-Allyn Spot Vision Screener
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Welch-Allyn Spot Vision ScreenerDiagnostic test
photograph of the eye
What is being measured
The primary outcome is the main question the study is designed to answer.
the SPOT will be effective in screening for amblyogenic risk factors
the Spot has a sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) necessary to appropriately perform visual triage in developmentally delayed children
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start11 May 2017
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision DisordersStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Colorado
- Sponsor type
- University, hospital or other
- Collaborators
- Welch Allyn
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479021
- Sponsor's protocol ID
- 16-1911 SPOT
- Status last verified
- Mar 2018
- First submitted
- 20 Mar 2018
- Last updated
- 23 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Welch Allyn Spot™ Vision Screener to Detect Amblyogenic Factors in Developmentally Delayed Children
- ClinicalTrials.gov ID
- NCT03479021
- Acronym / sponsor ID
- 16-1911 SPOT
- Conditions
- Vision Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Children's Hospital ColoradoUniversity, hospital or other
- Collaborators
- Welch Allyn
- Study start
- 11 May 2017 (actual)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 27 Mar 2018 (actual)
- 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 purpose of this protocol is to determine if the Welch-Allyn Spot Vision Screener (SPOT) is effective at detecting various risk factors for poor vision in developmentally delayed children. These children have a higher percentage of vision disorders than the average population. The SPOT screen itself takes about six seconds to complete. It produces a photograph of the eye and a print out with amount of hyperopia, myopia, astigmatism and pupil size. The subject will have three SPOT screens around the time of their standard of care eye exam. The data obtained from the three SPOT screens will be compared among themselves for accuracy and to the findings of the clinical eye exam.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The children have various disabilities or delays to include: Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), chromosomal abnormalities such as Down Syndrome, Cerebral Palsy (CP), and mental retardation (MR).
Key inclusion criteria (1 listed)
- child over 4 months of age social, behavioral, physical, or other handicap unable to complete age-appropriate vision screening
Key exclusion criteria (1 listed)
- glaucoma post intraocular surgery microphthalmia other serious eye disorder inability to complete SPOT screener
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Welch-Allyn Spot Vision Screenerphotograph of the eye | Diagnostic test | – |
Primary outcome
the SPOT will be effective in screening for amblyogenic risk factors
Time frame: 12 months
the Spot has a sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) necessary to appropriately perform visual triage in developmentally delayed children
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
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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.
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 Vision Disorders, run by Children's Hospital Colorado 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 1 inclusion and 1 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 23 Apr 2018. 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 Kyle Phillips (720-777-0524, kyle.phillips@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the SPOT will be effective in screening for amblyogenic risk factors (time frame: 12 months). 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 23 Apr 2018.