Visual Perceptual Learning Based Digital Therapeutics for Visual Field Defect After Stroke
- Conditions
- Hemianopsia, HomonymousVisual Fields Hemianopsia
- Interventions
- Device: VIVID BrainOther: No-treatment Control
- Registration Number
- NCT05525949
- Lead Sponsor
- Nunaps Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VIVID Brain VIVID Brain VIVID Brain, 5 times a week for 12 weeks No-treatment Control No-treatment Control No-treatment is administered during control period.
- Primary Outcome Measures
Name Time Method The sum of improved areas compared to baseline in the whole field 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 Outcome Measures
Name Time Method Changes in perimetric mean deviation relative to baseline in the whole field 12 weeks Changes in perimetric mean deviation relative to baseline in the whole field measured by Humphrey visual field test.
The sum of improved areas compared to baseline in the affected hemi-field 12 weeks 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.
Changes in mean total deviation relative to baseline in the affected hemi-field 12 weeks Changes in mean total deviation relative to baseline in the affected hemi-field measured by Humphrey visual field test.
Trial Locations
- Locations (12)
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Daejeon Eulji University Medical Center
🇰🇷Daejeon, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Goyang, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Konkuk University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Yeouido St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of