Comparative Validation of "Blinq" and "2WIN" Vision Screeners

NCT04195711 | Completed FDA Device

• 1 other identifier: ABCD blinq 2WIN
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

After 28 years of development, the binocular birefringence screener ("blinq," "Rebion") was commercially released. It need to be validated with AAPOS (American Association for Pediatric Ophthalmology and Strabismus) criteria in part because the next Uniform Standards document is pending. Adult and children pediatric and strabismus patients were screened with blinq and "2WIN" photoscreener with "CR" corneal reflex alignment test and then compared to confirmatory exam with age-appropriate determination of binocular status.

Conditions

Strabismic Amblyopia; Refractive Amblyopia; Strabismus

Keywords

vision screening, amblyopia

Outcome Measures

Primary Outcomes (1)

• 2003 AAPOS Uniform Amblyopia Risk Factor (ARF) Prevalence

  presence of refractive risk factor (anisometropia \>1.5 D, hyperopia\>3.5 D, astigmatism ≥1.5 D, myopia 3 D or more) and/or strabismus constant \>10 PD

  1 week

Secondary Outcomes (1)

• Binocularity

  1 week

Study Arms (1)

blinq screened

Patients screened by new birefringent screener

Diagnostic Test: objective pediatric vision screen, "blinq,"

Interventions

objective pediatric vision screen, "blinq," DIAGNOSTIC_TEST

hand-held birefringent screener for simultaneous foveation

Also known as: photoscreen, birefringent screen

blinq screened

Eligibility Criteria

• Age: 1 Year - 65 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in pediatric eye and adult strabismus practice

You may qualify if:

• Children in Pediatric Ophthalmology Practice Adult strabismus patients

You may not qualify if:

• patients with enucleations patients with eviscerations patients with exenterations

Sponsors & Collaborators

• Alaska Blind Child Discovery: lead

Study Sites (1)

Alaska Children's EYE & Strabismus

Anchorage, Alaska, 99508, United States

Location

Related Publications (4)

• Birch EE, Subramanian V, Weakley DR. Fixation instability in anisometropic children with reduced stereopsis. J AAPOS. 2013 Jun;17(3):287-90. doi: 10.1016/j.jaapos.2013.03.011.

  PMID: 23791411 BACKGROUND

• Gramatikov BI, Irsch K, Wu YK, Guyton DL. New pediatric vision screener, part II: electronics, software, signal processing and validation. Biomed Eng Online. 2016 Feb 4;15:15. doi: 10.1186/s12938-016-0128-7.

  PMID: 26847626 BACKGROUND

• Arnold SL, Arnold AW, Sprano JH, Arnold RW. Performance of the 2WIN Photoscreener With "CR" Strabismus Estimation in High-Risk Patients. Am J Ophthalmol. 2019 Nov;207:195-203. doi: 10.1016/j.ajo.2019.04.016. Epub 2019 May 9.

  PMID: 31077668 BACKGROUND

• Arnold RW. Comparative AAPOS Validation of the Birefringent Amblyopia Screener with Isolated Small-Angle Strabismus. Clin Ophthalmol. 2020 Jan 31;14:325-329. doi: 10.2147/OPTH.S242335. eCollection 2020.

  PMID: 32099317 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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 12, 2019
• Study Start: November 18, 2019
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2019
• Last Updated: October 19, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 1 month from now, ongoing
• Access Criteria: Study website

Locations

US (1)