Visual Perceptual Learning for the Treatment of Visual Field Defect

NCT ID: NCT04102605

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-17
• Study Completion Date: 2021-05-31

Brief 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.

Conditions

Visual Fields Hemianopsia; Hemianopsia, Homonymous

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nunap Vision

Nunap Vision , 5 days a week for 12 weeks

Group Type: EXPERIMENTAL

Nunap Vision

Intervention Type: DEVICE

Participants receive visual perceptual training using the Nunap Vision software

Nunap Vision-C

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

Group Type: SHAM_COMPARATOR

Nunap Vision-C

Intervention Type: DEVICE

Participants receive sham training using the Nunap Vision-C software

Interventions

Nunap Vision

Participants receive visual perceptual training using the Nunap Vision software

Intervention Type: DEVICE

Nunap Vision-C

Participants receive sham training using the Nunap Vision-C software

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nunaps Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sun U. Kwon, MD, PhD

Role: STUDY_CHAIR

Asan Medical Center

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Asan Medical Center

Seoul, , South Korea

Chung-Ang University Hospital

Seoul, , South Korea

Konkuk University Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DB_NV_P01

Identifier Type: -

Identifier Source: org_study_id