Visual Perceptual Learning for the Treatment of Visual Field Defect

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Visual Fields Hemianopsia, Hemianopsia, Homonymous

Intervention / Treatment
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* Device: Nunap Vision
* Device: Nunap Vision-C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nunap Vision<br>Nunap Vision , 5 days a week for 12 weeks | Device: Nunap Vision<br>* Participants receive visual perceptual training using the Nunap Vision software<br>|
| Sham Comparator: Nunap Vision-C<br>Nunap Vision-C, 5 days a week for 12 weeks | Device: Nunap Vision-C<br>* Participants receive sham training using the Nunap Vision-C software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area of Humphrey visual field where sensitivity increased by equal or more than 6 dB relative to baseline | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Humphrey visual field mean deviation relative to baseline | Changes in mean deviation value of whole field or defect field compared with the baseline value. The change of mean deviation ranges between -35 to +35 dB, of which higher value indicates better outcome. | 12 weeks | 
| Changes in scores of NEI-VFQ-25(the National Eye Institute Visual Function Questionnaire 25) relative to baseline | Changes in each components of NEI-VFQ-25 scores relative to baseline. The change of scores ranges between -100 to 100, of which higher value indicates better outcome. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visual field defect, visual perceptual learning, Humphrey visual field