Visual Perceptual Learning for the Treatment of Visual Field Defect (VIVID2)

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

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.

Study Overview

• Status: Completed
• Conditions: Visual Fields Hemianopsia; Hemianopsia, Homonymous
• Intervention / Treatment: Device: Nunap Vision; Device: Nunap Vision-C

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of
    • Konkuk University Hospital
  • Kyunggi-do
    • Seongnam, Kyunggi-do, Korea, Republic of
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nunaps Inc
• Investigators: Study Chair: Sun U. Kwon, MD, PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2019
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 6, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Visual field defect; visual perceptual learning; Humphrey visual field
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Blindness; Hemianopsia
• Other Study ID Numbers: DB_NV_P01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No