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SuspendedNCT04606355PDICheckUpdated Jul 31, 2024

Autostereoscopic Dynamic Near Vision Testing

An observational study in Visual Suppression, Amblyopia and Color Vision Defects, sponsored by Alaska Blind Child Discovery. Suspended at 1 site in United States. Open to participants aged 1 Year to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Alaska Blind Child Discovery · Observational

Why this study was suspended
updated technology nearly ready
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
300
Ages
1 Year to 95 Years
Sex
All
01

Study 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.

Read the detailed description

Subjects with normal vision, exceptional vision, or visual deficits have near vision tested on the PDI Check game and compared to other clinical tests.

Interclass Correlation and Bland Altman analysis utilized for continuous data. Sensitivity and Specificity calculated for defined clinical entities. Subjects are not assigned to either one screening test or another; instead different tests are compared.

02

Conditions studied

  • Visual Suppression
  • Amblyopia
  • Color Vision Defects

Keywords

  • stereopsis, visual acuity
03

Who can participate

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

Study population

Normal subjects and patients with near vision disorders

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • phthisis, enucleations
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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 Acuity · Diagnostic Test: stereopsis · Diagnostic Test: Color vision

Interventions

  • Diagnostic testVisual Acuity

    autostereoscopic, monocular dynamic force choice test

  • Diagnostic teststereopsis

    autostereoscopic dynamic forced-choice depth perception test

  • Diagnostic testColor vision

    autostereoscopic forced choice monocular or binocular color vision tests

05

What researchers measure

Primary outcomes

  1. Visual Acuity

    Gold Standard clinical test of visual acuity

    Time frame: day 1

  2. stereopsis

    Gold standard clinical test of stereopsis (ie Titmus)

    Time frame: day 1

  3. Color Vision

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

    Time frame: day 1

06

Study locations

1 site
  • Alaska Blind Child Discovery
    Anchorage, Alaska 99508, United States
07

References and documents

Publications

  • 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. PubMed 31322713 ↗
  • 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. PubMed 31385820 ↗
  • 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. PubMed 31118854 ↗
  • 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. PubMed 30834173 ↗
  • 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. PubMed 30361001 ↗
  • 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. PubMed 35210746 ↗
  • 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. PubMed 35177896 ↗
  • 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. PubMed 33623358 ↗
  • 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. PubMed 34007233 ↗

Related links

Individual participant data

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

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Registry details

Key details

Study ID
NCT04606355
Lead sponsor
Alaska Blind Child Discovery
Responsible party
Sponsor
First posted
Oct 28, 2020
Start date
Nov 16, 2017
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jul 31, 2024

Study contacts

Kyle A Smith, OD
principal investigator · Alaska Blind Child Discovery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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