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

Nunaps Inc5 sites in 1 country80 target enrollmentOctober 17, 2019

ConditionsVisual Fields Hemianopsia Hemianopsia, Homonymous

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Visual Fields Hemianopsia
Sponsor: Nunaps Inc
Enrollment: 80
Locations: 5
Primary Endpoint: Area of Humphrey visual field where sensitivity increased by equal or more than 6 dB relative to baseline
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 17, 2019

End Date

May 31, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nunaps Inc

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Area of Humphrey visual field where sensitivity increased by equal or more than 6 dB relative to baseline

Time Frame: 12 weeks

Improved regions have luminance sensitivity that increased by equal or more than 6 dB relative to baseline. The improved area ranges between 0 and 972 degree\^2, of which larger area indicates better outcome.

Secondary Outcomes

Changes in Humphrey visual field mean deviation relative to baseline(12 weeks)
Changes in scores of NEI-VFQ-25(the National Eye Institute Visual Function Questionnaire 25) relative to baseline(12 weeks)