Clinical trial NCT04102605: Visual Perceptual Learning for the Treatment of Visual Field Defect
Official title: Efficacy and Safety of Visual Perceptual Learning Using the Nunap Vision for Improvement of Visual Field Defect Caused by Brain Damage: Multi Center, Superiority Prove, Double-blind, Randomized, Confirmatory Study
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: 2019-09-25
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
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 damage. Half of participants will receive visual perceptual training using the Nunap Vision, while the other half will receive sham training using the Nunap Vision-C.


Eligibility criteria: Inclusion Criteria:

* Age 19-80 years
* Brain damage-induced visual field defect
* At least 6 months after brain lesion
* Minimum of 4 testing locations, where measured threshold ≤ 20dB
* Verified visual pathway damage using CT or MRI
* K-MMSE(Korean Mini Mental Status Examination) score ≥ 24
* Visual acuity equal or better than 20/40
* Able to use the investigational device
* Patient/legally authorized representative has signed the informed consent form

Exclusion Criteria:

* Unreliable Humphrey visual field test (any of fixation loss, false positive, false negative ≥ 20%)
* Complete hemianopsia with sensitivity of the whole hemifield ≤ 3 dB
* Epilepsy, photosensitivity, Parkinson's disease
* Bilateral visual field defect
* Hemispatial neglect
* Ophthalmologic disorder that may interfere the trial
* Inability to discontinue psychostimulants such as methylphenidate, modafinil, and amphetamine.
* Candidate for carotid endarterectomy or stenting
* Received ophthalmologic 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: Area of Humphrey visual field where sensitivity increased by equal or more than 6 dB relative to baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in Humphrey visual field mean deviation relative to baseline
timeFrame: 12 weeks
measure: Changes in scores of NEI-VFQ-25(the National Eye Institute Visual Function Questionnaire 25) relative to baseline
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyunggi-do
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
Study officials:
affiliation: Asan Medical Center
name: Sun U. Kwon, MD, PhD
role: STUDY_CHAIR
References: