NCT04102605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

October 17, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

1.6 years

First QC Date

September 23, 2019

Last Update Submit

June 6, 2021

Conditions

Visual Fields HemianopsiaHemianopsia, Homonymous

Keywords

Visual field defectvisual perceptual learningHumphrey visual field

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Nunap Vision

EXPERIMENTAL

Nunap Vision , 5 days a week for 12 weeks

Device: Nunap Vision

Nunap Vision-C

SHAM COMPARATOR

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

Device: Nunap Vision-C

Interventions

Nunap VisionDEVICE

Participants receive visual perceptual training using the Nunap Vision software

Nunap Vision
Nunap Vision-CDEVICE

Participants receive sham training using the Nunap Vision-C software

Nunap Vision-C

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Chung-Ang University Hospital

Seoul, South Korea

Location

Konkuk University Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Hemianopsia

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesBlindnessEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sun U. Kwon, MD, PhD

    Asan Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 25, 2019

Study Start

October 17, 2019

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

June 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(5)