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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05525949
Enrollment
93
Registered
2022-09-02
Start date
2022-10-19
Completion date
2023-11-08
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Fields Hemianopsia, Hemianopsia, Homonymous

Keywords

Visual field defect, Visual perceptual learning, Humphrey visual field

Brief 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.

Interventions

DEVICEVIVID Brain

Participants receive visual perceptual training using the VIVID Brain software.

No-treatment is administered during control period.

Sponsors

Nunaps Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The sum of improved areas compared to baseline in the whole field12 weeksThe 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

MeasureTime frameDescription
The sum of improved areas compared to baseline in the affected hemi-field12 weeksThe 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.
Changes in perimetric mean deviation relative to baseline in the whole field12 weeksChanges in perimetric mean deviation relative to baseline in the whole field measured by Humphrey visual field test.
Changes in mean total deviation relative to baseline in the affected hemi-field12 weeksChanges in mean total deviation relative to baseline in the affected hemi-field measured by Humphrey visual field test.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026