Comparative Validation of Blinq and 2WIN Vision Screeners

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Strabismic Amblyopia, Refractive Amblyopia, Strabismus

Intervention / Treatment
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* Diagnostic Test: objective pediatric vision screen, blinq,


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children in Pediatric Ophthalmology Practice Adult strabismus patients - Exclusion Criteria: patients with enucleations patients with eviscerations patients with exenterations -

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| blinq screened<br>Patients screened by new birefringent screener | Diagnostic Test: objective pediatric vision screen, blinq,<br>* hand-held birefringent screener for simultaneous foveation<br>* Other names: photoscreen, birefringent screen;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vision screening, amblyopia