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Comparative Validation of Blinq and 2WIN Vision Screeners

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04195711
Enrollment
100
Registered
2019-12-12
Start date
2019-11-18
Completion date
2019-11-26
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Amblyopia, Strabismic Amblyopia, Strabismus

Keywords

vision screening, amblyopia

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.

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.

Interventions

DIAGNOSTIC_TESTobjective pediatric vision screen, blinq,

hand-held birefringent screener for simultaneous foveation

Sponsors

Alaska Blind Child Discovery
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 65 Years

Inclusion criteria

Children in Pediatric Ophthalmology Practice Adult strabismus patients \-

Exclusion criteria

patients with enucleations patients with eviscerations patients with exenterations \-

Design outcomes

Primary

MeasureTime frameDescription
2003 AAPOS Uniform Amblyopia Risk Factor (ARF) Prevalence1 weekpresence 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

Secondary

MeasureTime frameDescription
Binocularity1 weekAny 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026