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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04102605
Other study ID # DB_NV_P01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 17, 2019
Est. completion date May 31, 2021

Study information

Verified date June 2021
Source Nunaps Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 31, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility 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

Study Design


Intervention

Device:
Nunap Vision
Participants receive visual perceptual training using the Nunap Vision software
Nunap Vision-C
Participants receive sham training using the Nunap Vision-C software

Locations

Country Name City State
Korea, Republic of 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

Sponsors (1)

Lead Sponsor Collaborator
Nunaps Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 12 weeks
Secondary 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. 12 weeks
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