N/A N=6 Treatment

VR System for Cross-modal Rehabilitation of Hemianopia

Hemianopia, Homonymous · Hemianopsia, Homonymous

Bottom Line

View on ClinicalTrials.gov: NCT04230486 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2022

Primary outcome: Primary: Humphrey Visual Field Perimetry — 108; 1272 visual angle degrees^2

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cross-model Visual Auditory Rehabilitation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Humphrey Visual Field Perimetry	594; 1356	—
PRIMARY Humphrey Visual Field Perimetry	594; 1356	—
PRIMARY Virtual Reality (VR) Visual Field Test--Mean Percent Correct	0; 91.667; 8.33; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Virtual Reality Visual Field Test--Mean Percent Correct	66.667; 100; 50; 100	—
PRIMARY Peripheral Visual Field Frame Test	100; 100; 100; 100; 100; 100	—
PRIMARY Peripheral Visual Field Frame Test	100; 100; 100; 100; 100; 100	—
PRIMARY Peripheral Visual Field Frame Test	100; 100; 100; 100; 100; 100	—
PRIMARY Peripheral Visual Field Frame Test	100; 100; 100; 100; 100; 100	—
SECONDARY National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)--Composite Score	60.793; 68.621; 69.893	—
SECONDARY NEI-VFQ-25--Composite Score	85.87	—
SECONDARY NEI-VFQ-25--General Health Score Subscale	50	—
SECONDARY NEI-VFQ-25--General Health Score Subscale	50	—
SECONDARY NEI-VFQ-25--General Vision Score Subscale	80	—
SECONDARY NEI-VFQ-25--General Vision Score Subscale	80	—
SECONDARY NEI-VFQ-25--Ocular Pain Score Subscale	100	—
SECONDARY NEI-VFQ-25--Ocular Pain Score Subscale	100	—
SECONDARY NEI-VFQ-25--Near Activities Score Subscale	75	—
SECONDARY NEI-VFQ-25--Near Activities Score Subscale	75	—
SECONDARY NEI-VFQ-25--Distance Activities Score Subscale	75	—
SECONDARY NEI-VFQ-25--Distance Activities Score Subscale	75	—
SECONDARY NEI-VFQ-25--Social Functioning Score Subscale	87.5	—
SECONDARY NEI-VFQ-25--Social Functioning Score Subscale	87.5	—
SECONDARY NEI-VFQ-25--Mental Health Score Subscale	98.73	—
SECONDARY NEI-VFQ-25--Mental Health Score Subscale	98.73	—
SECONDARY NEI-VFQ-25--Role Difficulties Score Subscale	100	—
SECONDARY NEI-VFQ-25--Role Difficulties Score Subscale	100	—
SECONDARY NEI-VFQ-25--Dependency Score Subscale	100	—
SECONDARY NEI-VFQ-25--Dependency Score Subscale	100	—
SECONDARY NEI-VFQ-25--Driving Score Subscale	58.33	—
SECONDARY NEI-VFQ-25--Driving Score Subscale	58.33	—
SECONDARY NEI-VFQ-25--Color Vision Score Subscale	100	—
SECONDARY NEI-VFQ-25--Color Vision Score Subscale	100	—
SECONDARY NEI-VFQ-25--Peripheral Vision Score Subscale	75	—
SECONDARY NEI-VFQ-25--Peripheral Vision Score Subscale	75	—
SECONDARY Veterans Affairs Low Vision Visual Function Questionnaire-48 (VA LV VFQ-48)--Item Score	1.248; 1.704	—
SECONDARY VA LV VFQ-48--Item Score	1.955	—
SECONDARY VA LV VFQ-48--Item Score	1.955	—
SECONDARY VA LV VFQ-48--Composite Score	-2.095	—
SECONDARY VA LV VFQ-48--Composite Score	-2.095	—
SECONDARY VA LV VFQ-48--Composite Score	-2.095	—
SECONDARY VA LV VFQ-48--Reading Domain Score	2.549	—
SECONDARY VA LV VFQ-48--Reading Domain Score	2.549	—
SECONDARY VA LV VFQ-48--Reading Domain Score	2.549	—

Summary

The purpose of this research study is to investigate the effectiveness of a new rehabilitation for visual hemianopia. The study team believes a cross-modal rehabilitation technique delivered by a virtual reality system can help restore the visual field for subjects with homonymous hemianopia.

Eligibility Criteria

Inclusion Criteria

Adult volunteers diagnosed with homonymous visual hemianopia / hemianopsia (ages 18-99)

Exclusion Criteria

Volunteers who are unable to complete the study tasks or understand instructions
Subjects that are not able to provide written consent or verbal assent
Subjects who are not available to complete all rehabilitation sessions

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04230486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.