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CompletedNCT036680672WINbusUpdated Jan 30, 2024

Performance of 2WIN Photoscreener With Corneal Reflex Compared to School Bus Retinoscopy by AAPOS Guidelines

An observational study in Refractive Errors, Amblyopia and Strabismus, sponsored by Alaska Blind Child Discovery. Completed at 1 site in United States. Open to participants aged 1 Week to 90 Years. Per ClinicalTrials.gov, last updated 2024-01-30.

Sponsored by Alaska Blind Child Discovery · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
471
Ages
1 Week to 90 Years
Sex
All
01

Study summary

Pediatric eye patients receive infrared photoscreener screening and skiascopy as a part of routine examination to compare ability to detect amblyopia risk factors.

Read the detailed description

Patients: Pediatric eye and adult strabismus patients undergoing routine examinations in a private ophthalmology practice.

Interventions: Infrared photoscreener / remote autorefractor such as 2 Winner (2WIN) ("Adaptica" - Padova, Italy) without and with infrared corneal reflex occluder. Child-friendly skiascopy before and after cycloplegic refraction.

Outcome: Amblyopia Risk Factors from comprehensive eye exam including refraction and strabismus.

Risk factors defined by American Association for Pediatric Ophthalmology and Strabismus (AAPOS) 2003 and 2013 guidelines.

**Please note that 2 Winner has nothing to do with actual device, but was required by the Clinical Trials Web entry.**

02

Conditions studied

  • Refractive Errors
  • Amblyopia
  • Strabismus
  • Development Delay
03

Who can participate

Ages eligible
1 Week to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

male and female children and adults with strabismus developmental delay is NOT excluded

Inclusion criteria

  • patient undergoing eye examination

Exclusion criteria

Exclusion Criteria:

  • none
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
471 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Photoscreener (2WIN)

    Accommodation, refraction and ocular alignment are estimated by infrared photoscreener using the photoscreener device. Photoscreener screening makes use of light crescent quantification from off-axis flash-to-lens in a camera.

    Device: 2WIN photoscreener

  • school bus skiascopy

    Refractive error estimated by child-friendly skiascopy rack holding lenses from +1.00 D to +10.00 D and -5.00 D. Skiascopy is a common, old-fashioned form of retinoscopy.

Interventions

  • Device2WIN photoscreener

    conventional infrared off-axis photoscreener

05

What researchers measure

Primary outcomes

  1. Amblyopia Risk Factor (refractive error and/or strabismus)

    Whether pre-defined, age-related risk factor is present. AAPOS has published standard levels of these refractive errors or binocular misalignment that render a child at risk of developing sight-threatening amblyopia.

    Time frame: 2 hours or less: Screening and Gold Standard Exam performed the same day, usually within the same hour.

06

Study locations

1 site
  • Alaska Children's EYE & Strabismus
    Anchorage, Alaska 99508, United States
07

References and documents

Publications

  • Tsao Wu M, Armitage MD, Trujillo C, Trujillo A, Arnold LE, Tsao Wu L, Arnold RW. Portable acuity screening for any school: validation of patched HOTV with amblyopic patients and Bangerter normals. BMC Ophthalmol. 2017 Dec 4;17(1):232. doi: 10.1186/s12886-017-0624-y. PubMed 29202721 ↗
  • Donahue SP, Arthur B, Neely DE, Arnold RW, Silbert D, Ruben JB; POS Vision Screening Committee. Guidelines for automated preschool vision screening: a 10-year, evidence-based update. J AAPOS. 2013 Feb;17(1):4-8. doi: 10.1016/j.jaapos.2012.09.012. Epub 2013 Jan 27. PubMed 23360915 ↗
  • Arnold RW, Davis B, Arnold LE, Rowe KS, Davis JM. Calibration and validation of nine objective vision screeners with contact lens-induced anisometropia. J Pediatr Ophthalmol Strabismus. 2013 May-Jun;50(3):184-90. doi: 10.3928/01913913-20130402-02. Epub 2013 Apr 9. PubMed 23565714 ↗
  • Arnold RW, Arnold AW, Hunt-Smith TT, Grendahl RL, Winkle RK. The Positive Predictive Value of Smartphone Photoscreening in Pediatric Practices. J Pediatr Ophthalmol Strabismus. 2018 Nov 19;55(6):393-396. doi: 10.3928/01913913-20180710-01. Epub 2018 Aug 29. PubMed 30160295 ↗
  • Kirk S, Armitage MD, Dunn S, Arnold RW. Calibration and validation of the 2WIN photoscreener compared to the PlusoptiX S12 and the SPOT. J Pediatr Ophthalmol Strabismus. 2014 Sep-Oct;51(5):289-92. doi: 10.3928/01913913-20140701-01. Epub 2014 Jul 8. PubMed 25000209 ↗
  • 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. PubMed 31077668 ↗
  • Arnold AW, Arnold SL, Sprano JH, Arnold RW. School bus accommodation-relaxing skiascopy. Clin Ophthalmol. 2019 Oct 8;13:1841-1851. doi: 10.2147/OPTH.S219031. eCollection 2019. PubMed 31631961 ↗

Individual participant data

Plan to share: Yes — de-identified database on-line available

Supporting information: Study protocol

08

Registry details

Key details

Study ID
NCT03668067
Lead sponsor
Alaska Blind Child Discovery
Responsible party
Sponsor
First posted
Sep 12, 2018
Start date
Apr 2, 2018
Primary completion
Oct 31, 2018
Completion
Oct 31, 2018
Last update
Jan 30, 2024

Study contacts

Robert W Arnold, MD
principal investigator · Alaska Blind Child Discovery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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