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Clinical Trials/NCT04102605
NCT04102605CompletedNot Applicable

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 enrollmentStarted: October 17, 2019Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
19 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Nunap Vision

Experimental

Nunap Vision , 5 days a week for 12 weeks

Intervention: Nunap Vision (Device)

Nunap Vision-C

Sham Comparator

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

Intervention: Nunap Vision-C (Device)

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)

Investigators

Sponsor
Nunaps Inc
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (5)

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