NCT04249505

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
708

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2020

Enrollment Period

1.2 years

First QC Date

January 29, 2020

Last Update Submit

July 21, 2021

Conditions

Keywords

photoscreeningphoto refractionauto refractionspectacle dispensing

Outcome Measures

Primary Outcomes (3)

  • Refractive Accuracy

    spherical equivalent

    1 day

  • Refractive Accuracy

    Vector transform J0 and J45 astigmatism

    1 day

  • Refractive Accuracy

    Spectacle comparison score (Percent similarity combined sphere-cylinder)

    1 day

Secondary Outcomes (1)

  • Impact of age

    1 day

Interventions

non-cycloplegia refraction by Adaptica "2WIN"

non-cycloplegic refraction by "Plusoptix A12" photoscreener

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

Eligibility Criteria

Age6 Months - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

children and adults attending pediatric ophthalmology and adult strabismus clinic

You may qualify if:

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

You may not qualify if:

  • Intraocular lens in place

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaska Children's EYE & Strabismus

Anchorage, Alaska, 99508, United States

Location

Related Publications (1)

  • 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.

    PMID: 31077668BACKGROUND

MeSH Terms

Conditions

AstigmatismVision Disorders

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bob Arnold, MD

    Coordinator Alaska Blind Child Discovery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2020

First Posted

January 31, 2020

Study Start

January 9, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

July 23, 2021

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

de-identified database shared on www.ABCD-Vision.org Website.

Shared Documents
ANALYTIC CODE
Time Frame
after study completed
Access Criteria
open
More information

Locations