SPOT Vision Screening

NCT ID: NCT03479021

Last Updated: 2018-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-11

Study Completion Date

2019-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vision Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Welch-Allyn Spot Vision Screener

photograph of the eye

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

child over 4 months of age social, behavioral, physical, or other handicap unable to complete age-appropriate vision screening

Exclusion Criteria

glaucoma post intraocular surgery microphthalmia other serious eye disorder inability to complete SPOT screener
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Welch Allyn

INDUSTRY

Sponsor Role collaborator

Children's Hospital Colorado

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Hospital Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kyle Phillips

Role: CONTACT

720-777-0524

Facility Contacts

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Kyle Phillips

Role: primary

702-777-0524

Other Identifiers

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16-1911 SPOT

Identifier Type: -

Identifier Source: org_study_id

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