Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

NCT01832883 | Completed

• 1 other identifier: rebiscan-002
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to compare the performance of the Pediatric Vision Scanner (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at detecting amblyopia and strabismus.

Conditions

Amblyopia; Strabismus

Outcome Measures

Primary Outcomes (1)

• Binocularity score

  Day 1

Secondary Outcomes (1)

• Presence of amblyopia risk factors

  Day 1

Study Arms (3)

Normal Controls

Structurally normal eye with equal visual acuity and normal stereopsis.

Device: Pediatric Vision Scanner

Referral required

Diagnosed with amblyopia or constant strabismus, categorized based on the GSE. Amblyopia: * VA \<20/40 and 2 logMAR lines difference in normal eye * Mild amblyopia (\>20/40) * Moderate amblyopia (20/40 and \<20/100) * Severe amblyopia (≥20/100 or worse) * Bilateral amblyopia: \>4 years age VA\<20/40 OU including high hyperopia or high astigmatism. Strabismus: * Constant: \>2 PD at near and or distance. * Intermittent: strabismus that could be controlled intermittently either through fusional mechanisms or a compensatory head position. Amblyogenic factor categorization: * 'Anisometropia'- (1.5 Diopters (D) or more difference in refractive error between the two eyes. * 'hypermetropia' (≥3.5 D), * 'myopia' (≥-4.0 D), * 'astigmatism' (≥1.5 D). * 'structural abnormalities' of the eye will not be excluded, but will be considered to have vision loss if visual acuity is 20/40 or worse.

Device: Pediatric Vision Scanner

Borderline

(no long-term harm to patient if referral is delayed, however the patient does have conditions that might benefit from monitoring): Equal visual acuity and no structural abnormality with any of the following: Amblyogenic factor, intermittent strabismus, structural abnormalities, refractive error, reduced stereopsis.

Device: Pediatric Vision Scanner

Interventions

Pediatric Vision Scanner DEVICE

Subject is scanned with a 2.5 second pediatric vision scanner device test.

Borderline; Normal Controls; Referral required

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children presenting for ophthalmic exam at eye clinic.

You may qualify if:

• Children aged 3-8 years
• Signed Informed consent by parent or guardian

You may not qualify if:

• Children with a history of developmental delay or cognitive deficit
• Children unable to complete the GSE (including visual acuity testing)

Sponsors & Collaborators

• Rebiscan, Inc.: lead
• Vanderbilt University: collaborator

Study Sites (1)

Vanderbilt Eye Institute

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Loudon SE, Rook CA, Nassif DS, Piskun NV, Hunter DG. Rapid, high-accuracy detection of strabismus and amblyopia using the pediatric vision scanner. Invest Ophthalmol Vis Sci. 2011 Jul 7;52(8):5043-8. doi: 10.1167/iovs.11-7503.

  PMID: 21642624 BACKGROUND

MeSH Terms

Conditions

Amblyopia; Strabismus

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; Ocular Motility Disorders; Cranial Nerve Diseases

Study Officials

• Sean Donahue, MD, PhD

  Vanderbilt Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: April 16, 2013
• Study Start: December 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 13, 2018

Record last verified: 2018-04

Locations

US (1)