Performance of 2WIN Photoscreener With Corneal Reflex Compared to School Bus Retinoscopy by AAPOS Guidelines
NCT ID: NCT03668067
Last Updated: 2024-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
471 participants
OBSERVATIONAL
2018-04-02
2018-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparative Validation of "Blinq" and "2WIN" Vision Screeners
NCT04195711
Refractive Accuracy of "2WIN" and Portable Autorefractors
NCT04249505
Improving Quality Vision Outcomes in Managed Care Setting While Reducing Cost by Use of Accurate, Automated Screening
NCT02536963
Comparing Preschool-Aged Refractive Measurements and Amblyopia Risks Using the 2WIN-S Portable Refractor with Vision Screening by Cycloplegic Refraction in Bangkok
NCT06148519
Assessment of Device for Treatment of Amblyopia
NCT02003235
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.\*\*
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
2WIN photoscreener
conventional infrared off-axis 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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
2WIN photoscreener
conventional infrared off-axis photoscreener
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
1 Week
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alaska Blind Child Discovery
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert W Arnold, MD
Role: PRINCIPAL_INVESTIGATOR
Alaska Blind Child Discovery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alaska Children's EYE & Strabismus
Anchorage, Alaska, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Study Documents
Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ABCD 2WIN bus
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.