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Completed

NCT Number: NCT04102605

Visual Perceptual Learning for the Treatment of Visual Field Defect

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.

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Key information

Conditions

Visual Fields Hemianopsia Blindness Eye Diseases Hemianopsia Hemianopsia, Homonymous Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nunap Vision

Device

Participants receive visual perceptual training using the Nunap Vision software

Nunap Vision-C

Device

Participants receive sham training using the Nunap Vision-C software

Primary outcomes

  1. 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

  1. Changes in Humphrey visual field mean deviation relative to baseline

    Time frame: 12 weeks

    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.

  2. Changes in scores of NEI-VFQ-25(the National Eye Institute Visual Function Questionnaire 25) relative to baseline

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Nunaps Inc

Industry

Registry information

Official study 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

Acronym: VIVID2

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 25, 2019
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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