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

Completed

• Conditions: Strabismic Amblyopia; Refractive Amblyopia; Strabismus
• Interventions: Diagnostic Test: objective pediatric vision screen, "blinq,"

• Registration Number: NCT04195711
• Lead Sponsor: Alaska Blind Child Discovery

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.

Study Timeline

• Study Start: 2019-11-18
• Primary Completion: 2019-11-26
• Study Completion: 2019-11-26
• Study First Submitted: 2019-11-28
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Last Update Submitted: 2020-10-14
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Children in Pediatric Ophthalmology Practice Adult strabismus patients

Exclusion Criteria

patients with enucleations patients with eviscerations patients with exenterations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
blinq screened	objective pediatric vision screen, "blinq,"	Patients screened by new birefringent screener

Primary Outcome Measures

Name	Time	Method
2003 AAPOS Uniform Amblyopia Risk Factor (ARF) Prevalence	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 Outcome Measures

Name	Time	Method
Binocularity	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)

Trial Locations

Locations (1)

Alaska Children's EYE & Strabismus; 🇺🇸 Anchorage, Alaska, United States