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Clinical Trials/NCT04230486
NCT04230486
Completed
N/A

Virtual Reality System for Cross-modal Rehabilitation of Hemianopia

Wake Forest University Health Sciences1 site in 1 country6 target enrollmentJune 29, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hemianopia, Homonymous
Sponsor
Wake Forest University Health Sciences
Enrollment
6
Locations
1
Primary Endpoint
Humphrey Visual Field Perimetry
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Detailed Description

The study tests a novel rehabilitation system, translated from promising cross-modal rehabilitation animal research, that is the first treatment capable of restoring the visual field for hemianopia patients. This noninvasive technique uses a virtual reality device to deliver visual and auditory stimulus. The goals of this study are to obtain proof of concept and procure rehabilitation data to support the development of this novel rehabilitation treatment.

Registry
clinicaltrials.gov
Start Date
June 29, 2020
End Date
July 30, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Humphrey Visual Field Perimetry

Time Frame: up to 2 Months

The area of the subject's visual field measured by 30-2 Humphrey visual field (HVF) perimetry. Both left and right sides will be tested. The deficit side includes is the hemianopic side. The intact side is the non-hemianopic side. During the HVF test, light is projected into a white bowl with a standardized background light intensity to form a circular stimulus, around 30 cm away from the patient's eye. The overall field mapping technique used is a form of static perimetry, where a stimulus appears in various areas of the field of vision. The patient indicates when they can see the stimulus and the perimetrist then records the point where the stimulus was seen. These data points are used to determine the patient's visual field.

Virtual Reality Visual Field Test--Mean Percent Correct

Time Frame: Day 29

Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals.

Virtual Reality (VR) Visual Field Test--Mean Percent Correct

Time Frame: Day 1

Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals.

Peripheral Visual Field Frame Test

Time Frame: 6 Months

The number of points subjects can detect in each location of the visual field along the horizontal meridian. Percent of correct trials in each location tested in the deficit and intact side. Locations at 15°, 30°, 45°, 60°, and 75° on the horizontal meridian on the left and right side were tested.

Secondary Outcomes

  • National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)--Composite Score(Baseline, 2 months, 3 months)
  • NEI-VFQ-25--General Vision Score Subscale(6 months)
  • NEI-VFQ-25--General Health Score Subscale(6 months)
  • NEI-VFQ-25--Near Activities Score Subscale(6 months)
  • NEI-VFQ-25--Peripheral Vision Score Subscale(6 months)
  • VA LV VFQ-48--Composite Score(6 months)
  • NEI-VFQ-25--Role Difficulties Score Subscale(6 months)
  • NEI-VFQ-25--Composite Score(6 month)
  • NEI-VFQ-25--Ocular Pain Score Subscale(6 months)
  • NEI-VFQ-25--Social Functioning Score Subscale(6 months)
  • NEI-VFQ-25--Dependency Score Subscale(6 months)
  • NEI-VFQ-25--Driving Score Subscale(6 months)
  • Veterans Affairs Low Vision Visual Function Questionnaire-48 (VA LV VFQ-48)--Item Score(Baseline, 2 months)
  • NEI-VFQ-25--Distance Activities Score Subscale(6 months)
  • NEI-VFQ-25--Color Vision Score Subscale(6 months)
  • VA LV VFQ-48--Item Score(6 months)
  • VA LV VFQ-48--Reading Domain Score(6 months)
  • NEI-VFQ-25--Mental Health Score Subscale(6 months)

Study Sites (1)

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