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Completed

NCT Number: NCT05525949

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

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.

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Key information

Conditions

Visual Fields Hemianopsia Blindness Eye Diseases Hemianopsia Hemianopsia, Homonymous Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Ansan Hospital, Ansan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent form

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

Treatment and study plan

VIVID Brain

Device

Participants receive visual perceptual training using the VIVID Brain software.

No-treatment control

Other

No-treatment is administered during control period.

Primary outcomes

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

    Time frame: 12 weeks

    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.

Secondary outcomes

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

    Time frame: 12 weeks

    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.

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Nunaps Inc

Industry

Registry information

Official study title

Treatment of Homonymous Visual Loss With Digital Therapeutics, VIVID Brain, Visual Perceptual Learning Device (HOGWAND Trial) : Multi Center, Randomized, Single-blind (Evaluator), Superiority Prove, Prospective Confirmatory Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 2, 2022
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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