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

Comparative Validation of the Birefringent Amblyopia Screener With Isolated Small-angle Strabismus

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.

Study Overview

• Status: Completed
• Conditions: Strabismus; Strabismic Amblyopia; Refractive Amblyopia
• Intervention / Treatment: Diagnostic test: objective pediatric vision screen, "blinq,"

Detailed Description

As a part of a new or follow-up comprehensive eye examinations, patients were screened with two novel objective devices according to AAPOS Uniform guidelines. Following the refractive, alignment and sensory testing, cycloplegic refraction was performed 30 or more minutes after cyclopentolate 1% drops. In cooperative patients, sensory tests including Worth 4-dot, Stereo Fly and "PDI Check" were performed to characterize binocularity. For younger patients, binocular function was estimated by Bruckner Test, 4- base out prism cover and the CR corneal reflex component of "2WIN" photoscreener ("Adaptica," Padova Italy).

Each patient was screened with a recently commercially released blinq screener according to manufacturer's recommendations. If an initial interpretation of "pass" or "refer" was not achieved, then repeat efforts with "timed out" or "inconclusive" were accomplished and results evaluated as if a "refer." An example of blinq birefringent screening is shown in [video].

Patients were screened with the binocular infrared autorefractor "2WIN" according to manufacturer guidelines. Refractive referral criteria were not age-stratified.

The "Rebion blinq" is a unique screening method and therefore we sought to provide appropriate validation. In addition to non-age stratified AAPOS 2003 Uniform guidelines, we collected all cases characterized by constant or persistent strabismus whether large- or small angle employing cover test, 4 base out test, Bruckner Test and "2WIN CR" function. We did not employ any method of retinal videographic analysis of fixation instability.

De-identified patient data recorded for sharing on study website.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Children's EYE & Strabismus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in pediatric eye and adult strabismus practice

Description

Inclusion Criteria:

Children in Pediatric Ophthalmology Practice Adult strabismus patients

-

Exclusion Criteria:

patients with enucleations patients with eviscerations patients with exenterations

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
blinq screened; Patients screened by new birefringent screener	Diagnostic test: objective pediatric vision screen, "blinq,"; hand-held birefringent screener for simultaneous foveation; Other Names: photoscreen, birefringent screen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocularity	Any defective Sensory (stereopsis > 200 sec arc, ocular Worth 4-Dot suppression distance and/or near) and/or objective ocular alignment (positive Bruckner Test, positive 4 prism base out test, or "2WIN" "CR" corneal reflex alignment > 10 PD)	1 week

Collaborators and Investigators

• Sponsor: Alaska Blind Child Discovery

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 18, 2019
• Primary Completion (ACTUAL): November 26, 2019
• Study Completion (ACTUAL): November 26, 2019

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (ACTUAL): December 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: vision screening, amblyopia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Cranial Nerve Diseases; Sensation Disorders; Ocular Motility Disorders; Vision Disorders; Strabismus; Amblyopia
• Other Study ID Numbers: ABCD blinq 2WIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: de-identified via website
• IPD Sharing Time Frame: 1 month from now, ongoing
• IPD Sharing Access Criteria: Study website
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No