Gocheck Kids vs. Welch Allyn Spot Vision Screener

NCT04321538 | Completed

• 1 other identifier: 2000026666
• Study Type: observational
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are conducting a prospective evaluation of the ability of two vision photoscreening devices (GoCheck Kids and the Welch Allyn Spot Vision Screener) to detect risk factors for amblyopia. Photoscreeners function similar to having a picture taken with a camera. Amblyopia is decreased vision in one or both eyes due to decreased vision development in the brain resulting from decreased visual stimulation. Children ages 1 year to less than 7 years of age referred to a pediatric ophthalmologist at Yale New Haven Health and Yale Medicine locations for a failed vision screen will be offered participation. The ability of each screening device to detect amblyopia risk factors will be compared with the results of a complete eye exam performed by the practitioner.

Conditions

Amblyopia

Keywords

GoCheck Kids; Welch Allyn Spot Vision Screener; Vision Screening; Photoscreening

Outcome Measures

Primary Outcomes (1)

• Sensitivities for amblyopia risk factor detection

  The sensitivity is the percentage of patients with amblyopia whose vision screen indicates they have an amblyopia risk factor. The sensitivity for the detection of amblyopia risk factors is determined individually for both the GoCheck Kids application and the Welch Allyn Spot Vision Screener by calculating the number of truly positive failed vision screens by the photoscreener (as determined by the gold standard physical exam including cycloplegic retinoscopy to look for refractive error and oculomotor exam to evaluate strabismus) and dividing by the sum of truly positive failed vision screens plus false-negative vision screens (the vision screener did not detect amblyopia risk factors when they were found to be present on the physical exam).

  Up to 2 hours

Secondary Outcomes (2)

• Sensitivity for detection of refractive error

  Up to 2 hours

• Sensitivity for detection of strabismus

  Up to 2 hours

Study Arms (1)

Failed Vision Screen Cohort

This cohort represents the entire group of study participants- children who were referred to Yale New Haven Hospital and Yale Medicine for a failed vision screen by either their primary care provider or their school.

Device: Gocheck Kids; Device: Welch Allyn Spot Vision Screener; Diagnostic Test: Physical Exam

Interventions

Gocheck Kids DEVICE

GoCheck Kids is a photoscreening device. It takes a special picture of the eyes that allows for detection of refractive error and eye misalignment.

Failed Vision Screen Cohort

Welch Allyn Spot Vision Screener DEVICE

The Welch Allyn Spot Vision Screener is a photoscreening device. It takes a special picture of the eyes that allows for the detection of refractive error and eye misalignment.

Failed Vision Screen Cohort

Physical Exam DIAGNOSTIC_TEST

Retinoscopy and an oculomotor testing will constitute the physical examination.

Failed Vision Screen Cohort

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children ages 1-\<7 years referred to a Yale New Haven Hospital and Yale Medicine associated pediatric ophthalmology practice for a failed vision screen.

You may qualify if:

• Children ages 1-\<7 years.

You may not qualify if:

• Children with a history of ocular surgery and children with ocular conditions or behavior that preclude obtainment of the screening photo images or completion of a complete eye exam.
• Children with an obstructed visual axis.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• US Preventive Services Task Force; Grossman DC, Curry SJ, Owens DK, Barry MJ, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW. Vision Screening in Children Aged 6 Months to 5 Years: US Preventive Services Task Force Recommendation Statement. JAMA. 2017 Sep 5;318(9):836-844. doi: 10.1001/jama.2017.11260.

  PMID: 28873168 BACKGROUND

MeSH Terms

Conditions

Amblyopia

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Martha A Howard, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 25, 2020
• Study Start: February 1, 2021
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)