NCT04606355

Brief Summary

This is an analysis of tests of near vision. Visual perception testing using a novel program on an interactive three dimensional electronic device: Autostereoscopic dynamic near games for monocular visual acuity, stereopsis and color are compared with other conventional or similar tests.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

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

November 16, 2017

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

7.1 years

First QC Date

October 22, 2020

Last Update Submit

July 30, 2024

Conditions

Keywords

stereopsis, visual acuity

Outcome Measures

Primary Outcomes (3)

  • Visual Acuity

    Gold Standard clinical test of visual acuity

    day 1

  • stereopsis

    Gold standard clinical test of stereopsis (ie Titmus)

    day 1

  • Color Vision

    Gold Standard clinical test of color vision (Ishihara, Innova Rabin)

    day 1

Study Arms (1)

PDI Check & Conventional

Autostereoscopic, dynamic forced choice game (ie on Nintendo 3DS) and Rosenbaum or HOTV near card, Ishihara color plates, Innova Rabin color test, Titmus Stereo test

Diagnostic Test: Visual AcuityDiagnostic Test: stereopsisDiagnostic Test: Color vision

Interventions

Visual AcuityDIAGNOSTIC_TEST

autostereoscopic, monocular dynamic force choice test

PDI Check & Conventional
stereopsisDIAGNOSTIC_TEST

autostereoscopic dynamic forced-choice depth perception test

PDI Check & Conventional
Color visionDIAGNOSTIC_TEST

autostereoscopic forced choice monocular or binocular color vision tests

PDI Check & Conventional

Eligibility Criteria

Age1 Year - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Normal subjects and patients with near vision disorders

You may qualify if:

  • Normal subjects, patients with deficient binocular vision, patients with color vision disorders

You may not qualify if:

  • phthisis, enucleations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaska Blind Child Discovery

Anchorage, Alaska, 99508, United States

Location

Related Publications (9)

  • Smith KA, Arnold AW, Sprano JH, Arnold SL, Arnold RW. Performance of a Quick Screening Version of the Nintendo 3DS PDI Check Game in Patients With Ocular Suppression. J Pediatr Ophthalmol Strabismus. 2019 Jul 1;56(4):234-237. doi: 10.3928/01913913-20190502-01.

    PMID: 31322713BACKGROUND
  • Martin SJ, Rowe KS, Hser N, Htoo HE, Khin R, Smith KA, Arnold RW. Compared Near-Vision Testing With the Nintendo 3DS PDI Check Game on the Thai-Burma Border. Asia Pac J Ophthalmol (Phila). 2019 Jul-Aug;8(4):330-334. doi: 10.1097/APO.0000000000000251.

    PMID: 31385820BACKGROUND
  • Smith KA, Damarjian AG, Molina A, Arnold RW. Calibrated measurement of acuity, color and stereopsis on a Nintendo(R) 3DS game console. Clin Optom (Auckl). 2019 Apr 30;11:47-55. doi: 10.2147/OPTO.S199992. eCollection 2019.

    PMID: 31118854BACKGROUND
  • Vancleef K, Serrano-Pedraza I, Sharp C, Slack G, Black C, Casanova T, Hugill J, Rafiq S, Burridge J, Puyat V, Enongue JE, Gale H, Akotei H, Collier Z, Haggerty H, Smart K, Powell C, Taylor K, Clarke MP, Morgan G, Read JCA. ASTEROID: A New Clinical Stereotest on an Autostereo 3D Tablet. Transl Vis Sci Technol. 2019 Feb 28;8(1):25. doi: 10.1167/tvst.8.1.25. eCollection 2019 Jan.

    PMID: 30834173BACKGROUND
  • Fanlo Zarazaga A, Gutierrez Vasquez J, Pueyo Royo V. Review of the main colour vision clinical assessment tests. Arch Soc Esp Oftalmol (Engl Ed). 2019 Jan;94(1):25-32. doi: 10.1016/j.oftal.2018.08.006. Epub 2018 Oct 22. English, Spanish.

    PMID: 30361001BACKGROUND
  • Arnold R, Angi M. Multifaceted Amblyopia Screening with blinq, 2WIN, and PDI Check. Clin Ophthalmol. 2022 Feb 15;16:411-421. doi: 10.2147/OPTH.S349638. eCollection 2022.

    PMID: 35210746BACKGROUND
  • Mahlen T, Arnold RW. Pediatric Non-Refractive Vision Screening with EyeSwift, PDI Check and Blinq: Non-Refractive Vision Screening with Two Binocular Video Games and Birefringent Scanning. Clin Ophthalmol. 2022 Feb 11;16:375-384. doi: 10.2147/OPTH.S344751. eCollection 2022.

    PMID: 35177896BACKGROUND
  • Brown S, Rue C, Smith K, Arnold R. Extraordinary Dynamic Near Vision in Champion Shotgun Shooters: PDI Check Evaluation of Stereo and Color without Floor Effect. Clin Ophthalmol. 2021 Feb 16;15:575-581. doi: 10.2147/OPTH.S298234. eCollection 2021.

    PMID: 33623358BACKGROUND
  • Arnold A, Smith K, Molina A, Damarjian A, Desatoff T, Arnold R. Trichromatic Enhanced Dynamic Color Screening on the PDI Check Nintendo 3DS Game. Clin Optom (Auckl). 2021 May 11;13:137-141. doi: 10.2147/OPTO.S305042. eCollection 2021.

    PMID: 34007233BACKGROUND

Related Links

MeSH Terms

Conditions

AmblyopiaColor Vision Defects

Interventions

Visual AcuityColor Vision

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCone DystrophyEye Diseases, Hereditary

Intervention Hierarchy (Ancestors)

Vision TestsDiagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisOcular Physiological PhenomenaVision, OcularSensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kyle A Smith, OD

    Alaska Blind Child Discovery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 28, 2020

Study Start

November 16, 2017

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

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

Time Frame
1 year after recruitment, then ongoing
Access Criteria
de-identified to any investigator with web access
More information

Locations