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

Nunaps Inc93 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Visual Fields Hemianopsia Hemianopsia, Homonymous

Interventions

VIVID BrainDEVICE

Participants receive visual perceptual training using the VIVID Brain software.

No-treatment ControlOTHER

No-treatment is administered during control period.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (12)

Korea University Ansan Hospital

Ansan, South Korea

Hallym University Sacred Heart Hospital

Anyang, South Korea

Daejeon Eulji University Medical Center

Daejeon, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.