Visual SuppressionPDICheckNCT04606355
Autostereoscopic Dynamic Near Vision Testing
An observational study of Visual Suppression and Amblyopia, run by Alaska Blind Child Discovery at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 year to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Suppression, Amblyopia, Color Vision Defects
- What is being tested?
- Visual Acuity, stereopsis and Color vision
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2017to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 95 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Normal subjects and patients with near vision disorders
Who may be able to join
- Normal subjects, patients with deficient binocular vision, patients with color vision disorders
Who cannot join
- phthisis, enucleations
Trial locations and contacts
1 site in 1 country.
United States1 site
Alaska Blind Child Discovery
Anchorage, Alaska, 99508
About this study
Official title: 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.
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.
- Conditions
- Visual Suppression, Amblyopia, Color Vision Defects
- Being tested
- Visual Acuity, stereopsis, Color vision
- Keywords
- stereopsis, visual acuity
- Medical subject headings
- Amblyopia, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual AcuityDiagnostic test
autostereoscopic, monocular dynamic force choice test
stereopsisDiagnostic test
autostereoscopic dynamic forced-choice depth perception test
Color visionDiagnostic test
autostereoscopic forced choice monocular or binocular color vision tests
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Visual Acuity; Diagnostic Test: stereopsis; Diagnostic Test: Color vision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Gold Standard clinical test of visual acuity
Measured: day 1
stereopsis
Gold standard clinical test of stereopsis (ie Titmus)
Measured: day 1
Color Vision
Gold Standard clinical test of color vision (Ishihara, Innova Rabin)
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start16 Nov 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: updated technology nearly ready
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Visual SuppressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaska Blind Child Discovery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle A Smith, OD, Principal investigator, Alaska Blind Child Discovery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606355
- Sponsor's protocol ID
- PDICheck
- Acronym
- PDICheck
- Status last verified
- Jul 2024
- First submitted
- 22 Oct 2020
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified database on www.ABCD-Vision.org
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 31322713Martin 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 31385820Smith 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 31118854Vancleef 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 30834173Fanlo 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 30361001Arnold 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 35210746Mahlen 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 35177896Brown 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 33623358Arnold 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autostereoscopic Dynamic Near Vision Testing of Acuity, Stereo and Color on PDI Check
- ClinicalTrials.gov ID
- NCT04606355
- Acronym / sponsor ID
- PDICheck / PDICheck
- Conditions
- Visual Suppression, Amblyopia, Color Vision Defects
- Keywords
- stereopsis, visual acuity
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: updated technology nearly ready
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Alaska Blind Child DiscoveryUniversity, hospital or other
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDI Check & Conventional | – | Diagnostic Test: Visual Acuity, Diagnostic Test: stereopsis, Diagnostic Test: Color visionAutostereoscopic, dynamic forced choice game (ie on Nintendo 3DS) and Rosenbaum or HOTV near card, Ishihara color plates, Innova Rabin color test, Titmus Stereo test |
Who may qualify
- Ages
- 1 year to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Normal subjects and patients with near vision disorders
Key inclusion criteria (1 listed)
- Normal subjects, patients with deficient binocular vision, patients with color vision disorders
Key exclusion criteria (1 listed)
- phthisis, enucleations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual Acuityautostereoscopic, monocular dynamic force choice test | Diagnostic test | PDI Check & Conventional |
| stereopsisautostereoscopic dynamic forced-choice depth perception test | Diagnostic test | PDI Check & Conventional |
| Color visionautostereoscopic forced choice monocular or binocular color vision tests | Diagnostic test | PDI Check & Conventional |
Primary outcome
Visual Acuity
Time frame: day 1
Gold Standard clinical test of visual acuity
stereopsis
Time frame: day 1
Gold standard clinical test of stereopsis (ie Titmus)
Color Vision
Time frame: day 1
Gold Standard clinical test of color vision (Ishihara, Innova Rabin)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Background: PubMed 31322713Smith 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.
- Background: PubMed 31385820Martin 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.
- Background: PubMed 31118854Smith 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.
- Background: PubMed 30834173Vancleef 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.
- Background: PubMed 30361001Fanlo 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.
- Background: PubMed 35210746Arnold 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.
- Background: PubMed 35177896Mahlen 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.
- Background: PubMed 33623358Brown 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.
- Background: PubMed 34007233Arnold 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.
- device websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. de-identified database on www.ABCD-Vision.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle A Smith, OD principal investigator
Alaska Blind Child Discovery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Suppression and Amblyopia, run by Alaska Blind Child Discovery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04606355, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.