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

NCT ID: NCT04195711

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-18

Study Completion Date

2019-11-26

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.

Conditions

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Strabismic Amblyopia Refractive Amblyopia Strabismus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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blinq screened

Patients screened by new birefringent screener

objective pediatric vision screen, "blinq,"

Intervention Type DIAGNOSTIC_TEST

hand-held birefringent screener for simultaneous foveation

Interventions

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objective pediatric vision screen, "blinq,"

hand-held birefringent screener for simultaneous foveation

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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photoscreen, birefringent screen

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

\-
Minimum Eligible Age

1 Year

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alaska Blind Child Discovery

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alaska Children's EYE & Strabismus

Anchorage, Alaska, United States

Site Status

Countries

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United States

References

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Birch EE, Subramanian V, Weakley DR. Fixation instability in anisometropic children with reduced stereopsis. J AAPOS. 2013 Jun;17(3):287-90. doi: 10.1016/j.jaapos.2013.03.011.

Reference Type BACKGROUND
PMID: 23791411 (View on PubMed)

Gramatikov BI, Irsch K, Wu YK, Guyton DL. New pediatric vision screener, part II: electronics, software, signal processing and validation. Biomed Eng Online. 2016 Feb 4;15:15. doi: 10.1186/s12938-016-0128-7.

Reference Type BACKGROUND
PMID: 26847626 (View on PubMed)

Arnold SL, Arnold AW, Sprano JH, Arnold RW. Performance of the 2WIN Photoscreener With "CR" Strabismus Estimation in High-Risk Patients. Am J Ophthalmol. 2019 Nov;207:195-203. doi: 10.1016/j.ajo.2019.04.016. Epub 2019 May 9.

Reference Type BACKGROUND
PMID: 31077668 (View on PubMed)

Arnold RW. Comparative AAPOS Validation of the Birefringent Amblyopia Screener with Isolated Small-Angle Strabismus. Clin Ophthalmol. 2020 Jan 31;14:325-329. doi: 10.2147/OPTH.S242335. eCollection 2020.

Reference Type BACKGROUND
PMID: 32099317 (View on PubMed)

Other Identifiers

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ABCD blinq 2WIN

Identifier Type: -

Identifier Source: org_study_id

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