Autostereoscopic Dynamic Near Vision Testing (PDICheck)

July 18, 2023 updated by: Alaska Blind Child Discovery

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Blind Child Discovery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 95 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Normal subjects and patients with near vision disorders

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • phthisis, enucleations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: day 1
Gold Standard clinical test of visual acuity
day 1
stereopsis
Time Frame: day 1
Gold standard clinical test of stereopsis (ie Titmus)
day 1
Color Vision
Time Frame: day 1
Gold Standard clinical test of color vision (Ishihara, Innova Rabin)
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alaska Blind Child Discovery

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2017

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDICheck

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

1 year after recruitment, then ongoing

IPD Sharing Access Criteria

de-identified to any investigator with web access

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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