Visual Fields HemianopsiaVIVID2NCT04102605
Visual Perceptual Learning for the Treatment of Visual Field Defect
A study testing Nunap Vision and Nunap Vision-C in people with Visual Fields Hemianopsia and Hemianopsia, Homonymous, run by Nunaps Inc at 5 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Visual Fields Hemianopsia, Hemianopsia, Homonymous
- What is being tested?
- Nunap Vision and Nunap Vision-C
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 17 Oct 2019to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Visual acuity equal or better than 20/40
- Able to use the investigational device
- Patient/legally authorized representative has signed the informed consent form
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
Asan Medical Center
Seoul
Chung-Ang University Hospital
Seoul
Konkuk University Hospital
Seoul
Samsung Medical Center
Seoul
About this study
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
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.
- Conditions
- Visual Fields Hemianopsia, Hemianopsia, Homonymous
- Being tested
- Nunap Vision, Nunap Vision-C
- Keywords
- Visual field defect, visual perceptual learning, Humphrey visual field
- Medical subject headings
- Hemianopsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nunap VisionDevice
Participants receive visual perceptual training using the Nunap Vision software
Nunap Vision-CDevice
Participants receive sham training using the Nunap Vision-C software
| Study group | Role | What they receive |
|---|---|---|
| Nunap Vision | Experimental | Nunap Vision , 5 days a week for 12 weeks Receives: Device: Nunap Vision |
| Nunap Vision-C | Sham comparator | Nunap Vision-C, 5 days a week for 12 weeks Receives: Device: Nunap Vision-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start17 Oct 2019
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visual Fields HemianopsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nunaps Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sun U. Kwon, MD, PhD, Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102605
- Sponsor's protocol ID
- DB_NV_P01
- Acronym
- VIVID2
- Status last verified
- Jun 2021
- First submitted
- 23 Sep 2019
- Last updated
- 8 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Namgung E, Kwon SU, Han MK, Kim GM, Kim HY, Park KY, Cho M, Choi HG, Nah HW, Lim HT, Kang DW. Digital therapeutics using virtual reality-based visual perceptual learning for visual field defects in stroke: A double-blind randomized trial. Brain Behav. 2024 May;14(5):e3525. doi: 10.1002/brb3.3525.
PubMed 38773793
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04102605
- Acronym / sponsor ID
- VIVID2 / DB_NV_P01
- Conditions
- Visual Fields Hemianopsia, Hemianopsia, Homonymous
- Keywords
- Visual field defect, visual perceptual learning, Humphrey visual field
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nunaps IncIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nunap Vision | Experimental | Device: Nunap VisionNunap Vision , 5 days a week for 12 weeks |
| Nunap Vision-C | Sham comparator | Device: Nunap Vision-CNunap Vision-C, 5 days a week for 12 weeks |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nunap VisionParticipants receive visual perceptual training using the Nunap Vision software | Device | Nunap Vision |
| Nunap Vision-CParticipants receive sham training using the Nunap Vision-C software | Device | Nunap Vision-C |
Primary outcome
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.
2 secondary outcomes
Changes in Humphrey visual field mean deviation relative to baseline
Time frame: 12 weeks
Changes in scores of NEI-VFQ-25(the National Eye Institute Visual Function Questionnaire 25) relative to baseline
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Derived from this study: PubMed 38773793Namgung E, Kwon SU, Han MK, Kim GM, Kim HY, Park KY, Cho M, Choi HG, Nah HW, Lim HT, Kang DW. Digital therapeutics using virtual reality-based visual perceptual learning for visual field defects in stroke: A double-blind randomized trial. Brain Behav. 2024 May;14(5):e3525. doi: 10.1002/brb3.3525.
- Individual participant dataSharing planned: No
Related trials for Visual Fields Hemianopsia
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Not yet recruiting
Multisensory Rehabilitation of Vision Loss After Cortical Damage
Cortical Blindness
Recruiting
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Hemianopia, Homonymous, Cortical Blindness, Unspecified Side of Brain
Active, not recruiting
Statistical Learning as a Novel Intervention for Cortical Blindness
Stroke, Ischemic, Hemianopia, Homonymous
Not yet recruitingObservational study
Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia
Homonymous Hemianopia, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun U. Kwon, MD, PhD study chair
Asan Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nunap Vision and Nunap Vision-C in people with Visual Fields Hemianopsia and Hemianopsia, Homonymous, run by Nunaps Inc at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area of Humphrey visual field where sensitivity increased by equal or more than 6 dB relative to baseline (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04102605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.