Visual Perceptual Learning for the Treatment of Visual Field Defect

Not Applicable

Completed

• Conditions: Hemianopsia, Homonymous; Visual Fields Hemianopsia
• Interventions: Device: Nunap Vision-C; Device: Nunap Vision

• Registration Number: NCT04102605
• Lead Sponsor: Nunaps Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-23
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-25
• Study Start: 2019-10-17
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-06
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Area of Humphrey visual field where sensitivity increased by equal or more than 6 dB relative to baseline	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Humphrey visual field mean deviation relative to baseline	12 weeks	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.
Changes in scores of NEI-VFQ-25(the National Eye Institute Visual Function Questionnaire 25) relative to baseline	12 weeks	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.

Trial Locations

Locations (5)

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Konkuk University Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Kyunggi-do, Korea, Republic of