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

Strabismus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04195711
• Other study ID #: ABCD blinq 2WIN
• Status: Completed
• Start date: November 18, 2019
• Est. completion date: November 26, 2019

Study information

• Verified date: December 2019
• Source: Alaska Blind Child Discovery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 26, 2019
• Est. primary completion date: November 26, 2019
• Gender: All
• Age group: 1 Year to 65 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Amblyopia
• Refractive Amblyopia
• Strabismic Amblyopia
• Strabismus

Intervention

Diagnostic Test:
• objective pediatric vision screen, "blinq,"
hand-held birefringent screener for simultaneous foveation

Locations

Country	Name	City	State
United States	Alaska Children's EYE & Strabismus	Anchorage	Alaska

Sponsors (1)

Lead Sponsor	Collaborator
Alaska Blind Child Discovery

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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