Autostereoscopic Dynamic Near Vision Testing

Amblyopia Clinical Trial

— PDICheck  

Official title:

Autostereoscopic Dynamic Near Vision Testing of Acuity, Stereo and Color on PDI Check

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04606355
• Other study ID #: PDICheck
• Status: Suspended
• 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
• 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

Related Conditions & MeSH terms

• Amblyopia
• Color Vision Defects
• Visual Suppression

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

External Links

•   device website