ClinicalTrials.gg
CompletedNCT05525949Updated Nov 13, 2023

Visual Perceptual Learning Based Digital Therapeutics for Visual Field Defect After Stroke

An interventional study of VIVID Brain and No-treatment Control in Visual Fields Hemianopsia and Hemianopsia, Homonymous, sponsored by Nunaps Inc. Completed at 12 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by Nunaps Inc · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

This study evaluates the efficacy of visual perceptual learning for the treatment of visual field defect caused by brain disease. Half of participants will receive visual perceptual training using the VIVID Brain. The other half will not receive any training because there is no standard treatment for visual field defect caused by brain disease.

02

Conditions studied

  • Visual Fields Hemianopsia
  • Hemianopsia, Homonymous

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Keywords

  • Visual field defect
  • Visual perceptual learning
  • Humphrey visual field
03

In context

Hemianopsia

63 studies on the registry are indexed under Hemianopsia; 24 are open to participants now.

This study's enrollment of 93 is above the median of 32 across 53 interventional studies indexed under Hemianopsia.

Browse Hemianopsia studies →

Lead sponsor

Nunaps Inc is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 19 years and older
  • At least 3 months after brain disease related to visual field defect
  • Verified brain disease in visual pathway related to occipital lobe, parietal lobe, temporal lobe or etc. using CT or MRI
  • Brain disease induced visual field defect
  • Able to use the VR(Virtual Reality) device
  • Able to use the app with a smart phone
  • Patient/legally authorized representative has signed the form

Exclusion criteria

Exclusion Criteria:

  • Complete hemianopsia
  • Epilepsy, photosensitivity, Parkinson's disease
  • Bilateral visual field defect
  • Hemispatial neglect
  • Ophthalmologic disorder that may interfere the trial. (Ptosis of Eyelid, Corneal Opacity, Diabetic Retinopathy, Glaucoma, Macular Degeneration etc.)
  • Inability to discontinue psychostimulants such as methylphenidate, modafinil, and amphetamine.
  • Candidate for carotid endarterectomy or stenting
  • Received ophthalmologic surgery or laser surgery within 3 months, except for the cataract surgery
  • Pregnant or breast feeding
  • Participating in other clinical trial
  • Any other condition that, in the opinion of the investigator, precludes participation in the trial
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
93 participants (actual)

Study arms

  • Experimental
    VIVID Brain

    VIVID Brain, 5 times a week for 12 weeks

    Device: VIVID Brain

  • Other
    No-treatment Control

    No-treatment is administered during control period.

    Other: No-treatment Control

Interventions

  • DeviceVIVID Brain

    Participants receive visual perceptual training using the VIVID Brain software.

  • OtherNo-treatment Control

    No-treatment is administered during control period.

06

What researchers measure

Primary outcomes

  1. The sum of improved areas compared to baseline in the whole field

    The sum of areas where sensitivity increased by more than 6 dB compared to baseline in the whole field measured by Humphrey visual field test. The improved area ranges between 0 and 2,736 degree\^2, of which larger area indicates better outcome.

    Time frame: 12 weeks

Secondary outcomes

  1. The sum of improved areas compared to baseline in the affected hemi-field

    The sum of areas where sensitivity increased by more than 6 dB compared to baseline in the affected hemi-field measured by Humphrey visual field test.

    Time frame: 12 weeks

  2. Changes in perimetric mean deviation relative to baseline in the whole field

    Changes in perimetric mean deviation relative to baseline in the whole field measured by Humphrey visual field test.

    Time frame: 12 weeks

  3. Changes in mean total deviation relative to baseline in the affected hemi-field

    Changes in mean total deviation relative to baseline in the affected hemi-field measured by Humphrey visual field test.

    Time frame: 12 weeks

07

Study locations

12 sites
  • Korea University Ansan Hospital
    Ansan, Korea, Republic of
  • Hallym University Sacred Heart Hospital
    Anyang, Korea, Republic of
  • Daejeon Eulji University Medical Center
    Daejeon, Korea, Republic of
  • Inje University Ilsan Paik Hospital
    Goyang, Korea, Republic of
  • Seoul National University Bundang Hospital
    Seongnam, Korea, Republic of
  • Asan Medical Center
    Seoul, Korea, Republic of
  • Chung-Ang University Hospital
    Seoul, Korea, Republic of
  • Konkuk University Hospital
    Seoul, Korea, Republic of
  • Samsung Medical Center
    Seoul, Korea, Republic of
  • The Catholic University of Korea Seoul St. Mary's Hospital
    Seoul, Korea, Republic of
  • The Catholic University of Korea Yeouido St. Mary's Hospital
    Seoul, Korea, Republic of
  • Ulsan University Hospital
    Ulsan, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05525949
Lead sponsor
Nunaps Inc
Responsible party
Sponsor
First posted
Sep 2, 2022
Start date
Oct 19, 2022
Primary completion
Aug 11, 2023
Completion
Nov 8, 2023
Last update
Nov 13, 2023

Study contacts

Gyeong-Moon Kim, MD, PhD
study chair · Samsung Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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