ClinicalTrials.gg
CompletedNCT04102605VIVID2Updated Jun 8, 2021

Visual Perceptual Learning for the Treatment of Visual Field Defect

An interventional study of Nunap Vision and Nunap Vision-C in Visual Fields Hemianopsia and Hemianopsia, Homonymous, sponsored by Nunaps Inc. Completed at 5 sites in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-06-08.

Sponsored by Nunaps Inc · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
19 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Visual Fields Hemianopsia
  • Hemianopsia, Homonymous

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Keywords

  • Visual field defect
  • visual perceptual learning
  • Humphrey visual field
03

In context

Hemianopsia

63 studies on the registry are indexed under Hemianopsia; 24 are open to participants now.

This study's enrollment of 80 is above the median of 32 across 53 interventional studies indexed under Hemianopsia.

Browse Hemianopsia studies →

Lead sponsor

Nunaps Inc is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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-(Korean Mini Mental Status Examination) score ≥ 24
  • Visual acuity equal or better than 20/40
  • Able to use the device
  • Patient/legally authorized representative has signed the form

Exclusion criteria

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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Nunap Vision

    Nunap Vision , 5 days a week for 12 weeks

    Device: Nunap Vision

  • Sham comparator
    Nunap Vision-C

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

    Device: Nunap Vision-C

Interventions

  • DeviceNunap Vision

    Participants receive visual perceptual training using the Nunap Vision software

  • DeviceNunap Vision-C

    Participants receive sham training using the Nunap Vision-C software

06

What researchers measure

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.

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

07

Study locations

5 sites
  • Seoul National University Bundang Hospital
    Seongnam, Kyunggi-do, Korea, Republic of
  • Asan Medical Center
    Seoul, Korea, Republic of
  • Chung-Ang University Hospital
    Seoul, Korea, Republic of
  • Konkuk University Hospital
    Seoul, Korea, Republic of
  • Samsung Medical Center
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2019 to primary completion in May 2021, 19 months.

Of 36 interventional studies with no phase under Hemianopsia, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 95. This study's 19 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2019
First posted
Sep 25, 2019
StartActual
Oct 17, 2019
Primary completionActual
May 31, 2021
CompletionActual
May 31, 2021
Last update
Jun 8, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04102605
Lead sponsor
Nunaps Inc
Responsible party
Sponsor
First posted
Sep 25, 2019
Start date
Oct 17, 2019
Primary completion
May 31, 2021
Completion
May 31, 2021
Last update
Jun 8, 2021

Study contacts

Sun U. Kwon, MD, PhD
study chair · Asan Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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