Clinical trial NCT03668067: Performance of 2WIN Photoscreener With Corneal Reflex Compared to School Bus Retinoscopy by AAPOS Guidelines
Official title: Refractive and Strabismic Amblyopia Risk Factors Detected by Infrared Photoscreener and School Bus Skiascopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Errors
Amblyopia
Strabismus
Development Delay
Lead sponsor: Alaska Blind Child Discovery
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 471
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male and female children and adults with strabismus developmental delay is NOT excluded

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

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.\*\*

Eligibility criteria: Inclusion Criteria:

* patient undergoing eye examination

Exclusion Criteria:

* none

Primary outcomes:
measure: Amblyopia Risk Factor (refractive error and/or strabismus)
timeFrame: 2 hours or less: Screening and Gold Standard Exam performed the same day, usually within the same hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Children's EYE & Strabismus
state: Alaska
Study officials:
affiliation: Alaska Blind Child Discovery
name: Robert W Arnold, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.