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

Nunaps Inc12 sites in 1 country93 target enrollmentOctober 19, 2022

ConditionsVisual Fields Hemianopsia Hemianopsia, Homonymous

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Visual Fields Hemianopsia
Sponsor: Nunaps Inc
Enrollment: 93
Locations: 12
Primary Endpoint: The sum of improved areas compared to baseline in the whole field
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

October 19, 2022

End Date

November 8, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nunaps Inc

Responsible Party

Sponsor

Eligibility Criteria

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

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

Changes in perimetric mean deviation relative to baseline in the whole field(12 weeks)
The sum of improved areas compared to baseline in the affected hemi-field(12 weeks)
Changes in mean total deviation relative to baseline in the affected hemi-field(12 weeks)