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

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.

Official 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

Conditions
-----------------
Visual Fields Hemianopsia, Hemianopsia, Homonymous

Intervention / Treatment
-----------------
* Device: VIVID Brain
* Other: No-treatment Control


Participation Criteria
=================
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 Any other condition that, in the opinion of the investigator, precludes participation in the trial

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIVID Brain<br>VIVID Brain, 5 times a week for 12 weeks | Device: VIVID Brain<br>* Participants receive visual perceptual training using the VIVID Brain software.<br>|
| Other: No-treatment Control<br>No-treatment is administered during control period. | Other: No-treatment Control<br>* No-treatment is administered during control period.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| 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. | 12 weeks | 
| 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. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Visual field defect, Visual perceptual learning, Humphrey visual field