Autostereoscopic Dynamic Near Vision Testing (PDICheck)

• ClinicalTrials.gov Identifier: NCT04606355
• Recruitment Status: Active, not recruiting
• First Posted: October 28, 2020
• Last Update Posted: February 15, 2022
• Sponsor: Alaska Blind Child Discovery
• Information provided by (Responsible Party): Alaska Blind Child Discovery

Study Description

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.

Condition or disease	Intervention/treatment
Visual Suppression; Amblyopia; Color Vision Defects	Diagnostic Test: Visual Acuity; Diagnostic Test: stereopsis; Diagnostic Test: Color vision

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 300 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Autostereoscopic Dynamic Near Vision Testing of Acuity, Stereo and Color on PDI Check
• Actual Study Start Date: November 16, 2017
• Estimated Primary Completion Date: March 17, 2022
• Estimated Study Completion Date: March 17, 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
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; autostereoscopic, monocular dynamic force choice test; Diagnostic Test: stereopsis; autostereoscopic dynamic forced-choice depth perception test; Diagnostic Test: Color vision; autostereoscopic forced choice monocular or binocular color vision tests

Outcome Measures

Primary Outcome Measures :

1. Visual Acuity [ Time Frame: day 1 ]
   Gold Standard clinical test of visual acuity
2. stereopsis [ Time Frame: day 1 ]
   Gold standard clinical test of stereopsis (ie Titmus)
3. Color Vision [ Time Frame: day 1 ]
   Gold Standard clinical test of color vision (Ishihara, Innova Rabin)

Eligibility Criteria

• Ages Eligible for Study: 1 Year to 95 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Normal subjects and patients with near vision disorders

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• phthisis, enucleations

Contacts and Locations

Locations

United States, Alaska

Alaska Blind Child Discovery

Anchorage, Alaska, United States, 99508

Sponsors and Collaborators

Alaska Blind Child Discovery

Investigators

• Principal Investigator: Kyle A Smith, OD; Alaska Blind Child Discovery

More Information

Additional Information:

device website 

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.

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.

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

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.

Fanlo Zarazaga A, Gutiérrez Vásquez 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. Review. English, Spanish.

• Responsible Party: Alaska Blind Child Discovery
• ClinicalTrials.gov Identifier: NCT04606355
• Other Study ID Numbers: PDICheck
• First Posted: October 28, 2020
• Last Update Posted: February 15, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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
• URL: http://www.abcd-vision.org/references/index.html

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alaska Blind Child Discovery:

stereopsis, visual acuity

Additional relevant MeSH terms:

Amblyopia; Color Vision Defects; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Cone Dystrophy; Eye Diseases, Hereditary