NCT04195711

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Alaska Blind Child Discovery · Academic / Other
• Sex: All
• Age: 1 Year – 65 Years
• Healthy volunteers: —

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.

Conditions

• Strabismic Amblyopia
• Refractive Amblyopia
• Strabismus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	objective pediatric vision screen, "blinq,"	hand-held birefringent screener for simultaneous foveation

Timeline

• Start date: 2019-11-18
• Primary completion: 2019-11-26
• Completion: 2019-11-26
• First posted: 2019-12-12
• Last updated: 2020-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study