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OpenTrials
Completed

NCT Number: NCT04195711

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

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children in Pediatric Ophthalmology Practice Adult strabismus patients

-

Exclusion criteria

patients with enucleations patients with eviscerations patients with exenterations

-

Treatment and study plan

objective pediatric vision screen, "blinq,"

Diagnostic Test

hand-held birefringent screener for simultaneous foveation

Other names: photoscreen, birefringent screen

Primary outcomes

  1. 2003 AAPOS Uniform Amblyopia Risk Factor (ARF) Prevalence

    Time frame: 1 week

    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

Secondary outcomes

  1. Binocularity

    Time frame: 1 week

    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)

Sponsors and collaborators

Lead sponsor

Alaska Blind Child Discovery

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2019
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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