Clinical trial NCT05525949: Visual Perceptual Learning Based Digital Therapeutics for Visual Field Defect After Stroke
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Fields Hemianopsia
Hemianopsia, Homonymous
Keywords: Visual field defect
Visual perceptual learning
Humphrey visual field
Lead sponsor: Nunaps Inc
Sponsor class: INDUSTRY
First posted: 2022-09-02
Enrollment: 93
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The sum of improved areas compared to baseline in the whole field
timeFrame: 12 weeks
Secondary outcomes:
measure: The sum of improved areas compared to baseline in the affected hemi-field
timeFrame: 12 weeks
measure: Changes in perimetric mean deviation relative to baseline in the whole field
timeFrame: 12 weeks
measure: Changes in mean total deviation relative to baseline in the affected hemi-field
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Daejeon
country: Korea, Republic of
facility: Daejeon Eulji University Medical Center
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Yeouido St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Samsung Medical Center
name: Gyeong-Moon Kim, MD, PhD
role: STUDY_CHAIR
References: