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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nunaps Inc
- Enrollment
- 93
- Locations
- 12
- Primary Endpoint
- The sum of improved areas compared to baseline in the whole field
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
VIVID Brain
VIVID Brain, 5 times a week for 12 weeks
Intervention: VIVID Brain (Device)
No-treatment Control
No-treatment is administered during control period.
Intervention: No-treatment Control (Other)
Outcomes
Primary Outcomes
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
- The sum of improved areas compared to baseline in the affected hemi-field(12 weeks)
- Changes in perimetric mean deviation relative to baseline in the whole field(12 weeks)
- Changes in mean total deviation relative to baseline in the affected hemi-field(12 weeks)