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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04606355
Other study ID # PDICheck
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date November 16, 2017
Est. completion date December 31, 2024

Study information

Verified date July 2023
Source Alaska Blind Child Discovery
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Suspended
Enrollment 300
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 95 Years
Eligibility Inclusion Criteria: - Normal subjects, patients with deficient binocular vision, patients with color vision disorders Exclusion Criteria: - phthisis, enucleations

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Visual Acuity
autostereoscopic, monocular dynamic force choice test
stereopsis
autostereoscopic dynamic forced-choice depth perception test
Color vision
autostereoscopic forced choice monocular or binocular color vision tests

Locations

Country Name City State
United States Alaska Blind Child Discovery Anchorage Alaska

Sponsors (1)

Lead Sponsor Collaborator
Alaska Blind Child Discovery

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Acuity Gold Standard clinical test of visual acuity day 1
Primary stereopsis Gold standard clinical test of stereopsis (ie Titmus) day 1
Primary Color Vision Gold Standard clinical test of color vision (Ishihara, Innova Rabin) day 1
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