Recruiting

Vision Screening

Sponsor:

Children's Hospital Colorado

Code:

NCT03479021

Conditions

Vision Disorders

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

Interventions

Welch-Allyn Spot Vision Screener

Study Details

Brief 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. 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

Study ID

NCT03479021

Start date

May 11, 2017

Status verified date

Mar, 2018

Completion date

May 31, 2019

Anticipated

Primary completion date

May 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

Welch-Allyn Spot Vision Screener

photograph of the eye

Primary outcome measure

  • the SPOT will be effective in screening for amblyogenic risk factors [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045-7106

Contacts

More Information

Sponsor

Children's Hospital Colorado

Last update posted

Apr 23, 2018

Last verified

Mar, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Colorado on 2018-04-23.