Visual Perceptual Learning for the Treatment of Visual Field Defect

Hemianopsia, Homonymous Clinical Trial

— VIVID2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04102605
• Other study ID #: DB_NV_P01
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hemianopsia
• Hemianopsia, Homonymous
• Visual Fields Hemianopsia

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