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CompletedNCT04249505Updated Jul 23, 2021

Refractive Accuracy of "2WIN" and Portable Autorefractors

An observational study in Refractive Error - Myopia Axial, Astigmatism and Accomodation, sponsored by Alaska Blind Child Discovery. Completed at 1 site in United States. Open to participants aged 6 Months to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-23.

Sponsored by Alaska Blind Child Discovery · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
708
Ages
6 Months to 95 Years
Sex
All
01

Study summary

Youth and some adults have photoscreening refractions and hand-held auto refraction before cycloplegia refraction during new and follow up eye examinations. Vector math is applied to each refraction to determine how closely the hand-held "dry" devices match actual refraction.

Read the detailed description

A closeness-of-fit algorithm utilizing vector transformations of astigmatism is designed and applied to 50-years of clinical international refractive experience.

As a part of new and follow up comprehensive eye examinations, patients and parents consented to confirm the cycloplegic refraction to other portable refractive tools.

The ability of photoscreeners "2WIN" ("Adaptica," Padova italy), "PlusoptiX A12" (Nuremberg, Germany) and "Retinomax" (Righton, Tokyo, Japan) to match actual refraction is assessed utilizing the new algorithm.

This algorithm could then be applied to batches of donated spectacles distend by charitable organizations worldwide if portable auto refracting devices are employed.

02

Conditions studied

  • Refractive Error - Myopia Axial
  • Astigmatism
  • Accomodation
  • Visual Impairment
  • Hyperopia of Both Eyes

Keywords

  • photoscreening
  • photo refraction
  • auto refraction
  • spectacle dispensing
03

Who can participate

Ages eligible
6 Months to 95 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

children and adults attending pediatric ophthalmology and adult strabismus clinic

Inclusion criteria

  • Patient undergoing new or follow examination at pediatric eye and adult strabismus clinic Willing to undergo screening refractive device developmental delays included

Exclusion criteria

Exclusion Criteria:

  • Intraocular lens in place
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
708 participants (actual)
Patient registry
No

Interventions

  • Device"2WIN" Photoscreener

    non-cycloplegia refraction by Adaptica "2WIN"

  • Device"Plusoptix A12"

    non-cycloplegic refraction by "Plusoptix A12" photoscreener

  • Device"Retinomax"

    non-cycloplegic refraction by "Retinomax K+" auto refractor

05

What researchers measure

Primary outcomes

  1. Refractive Accuracy

    spherical equivalent

    Time frame: 1 day

  2. Refractive Accuracy

    Vector transform J0 and J45 astigmatism

    Time frame: 1 day

  3. Refractive Accuracy

    Spectacle comparison score (Percent similarity combined sphere-cylinder)

    Time frame: 1 day

Secondary outcomes

  1. Impact of age

    Spectacle similarity score striated by age relative to patient's ability to accommodate

    Time frame: 1 day

06

Study locations

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

References and documents

Publications

  • 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 ↗

Individual participant data

Plan to share: Yes — de-identified database shared on www.ABCD-Vision.org Website.

Supporting information: Analytic code

08

Registry details

Key details

Study ID
NCT04249505
Lead sponsor
Alaska Blind Child Discovery
Responsible party
Sponsor
First posted
Jan 31, 2020
Start date
Jan 9, 2020
Primary completion
Apr 1, 2021
Completion
Apr 1, 2021
Last update
Jul 23, 2021

Study contacts

Bob Arnold, MD
principal investigator · Coordinator 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 Jul 2020. You cannot join it, but the record below documents what was studied.

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