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

Primary Purpose

Visual Fields Hemianopsia, Hemianopsia, Homonymous

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nunap Vision
Nunap Vision-C
Sponsored by
Nunaps Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visual Fields Hemianopsia focused on measuring Visual field defect, visual perceptual learning, Humphrey visual field

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Chung-Ang University Hospital
  • Konkuk University Hospital
  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Nunap Vision

Nunap Vision-C

Arm Description

Nunap Vision , 5 days a week for 12 weeks

Nunap Vision-C, 5 days a week for 12 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 23, 2019
Last Updated
June 6, 2021
Sponsor
Nunaps Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04102605
Brief Title
Visual Perceptual Learning for the Treatment of Visual Field Defect
Acronym
VIVID2
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 17, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nunaps Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Fields Hemianopsia, Hemianopsia, Homonymous
Keywords
Visual field defect, visual perceptual learning, Humphrey visual field

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nunap Vision
Arm Type
Experimental
Arm Description
Nunap Vision , 5 days a week for 12 weeks
Arm Title
Nunap Vision-C
Arm Type
Sham Comparator
Arm Description
Nunap Vision-C, 5 days a week for 12 weeks
Intervention Type
Device
Intervention Name(s)
Nunap Vision
Intervention Description
Participants receive visual perceptual training using the Nunap Vision software
Intervention Type
Device
Intervention Name(s)
Nunap Vision-C
Intervention Description
Participants receive sham training using the Nunap Vision-C software
Primary Outcome Measure Information:
Title
Area of Humphrey visual field where sensitivity increased by equal or more than 6 dB relative to baseline
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in Humphrey visual field mean deviation relative to baseline
Description
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.
Time Frame
12 weeks
Title
Changes in scores of NEI-VFQ-25(the National Eye Institute Visual Function Questionnaire 25) relative to baseline
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun U. Kwon, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Kyunggi-do
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Konkuk University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Visual Perceptual Learning for the Treatment of Visual Field Defect

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