Hemianopia, HomonymousNCT04230486
VR System for Cross-modal Rehabilitation of Hemianopia
A study testing Cross-model Visual Auditory Rehabilitation in people with Hemianopia, Homonymous and Hemianopsia, Homonymous, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hemianopia, Homonymous, Hemianopsia, Homonymous
- What is being tested?
- Cross-model Visual Auditory Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2020to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult volunteers diagnosed with homonymous visual hemianopia / hemianopsia (ages 18-99)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27101
About this study
Official title: Virtual Reality System for Cross-modal Rehabilitation of Hemianopia
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.
Read the 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.
- Conditions
- Hemianopia, Homonymous, Hemianopsia, Homonymous
- Being tested
- Cross-model Visual Auditory Rehabilitation
- Keywords
- Hemianopia, Virtual Reality, Rehabilitation, Hemianopsia
- Medical subject headings
- Hemianopsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-model Visual Auditory RehabilitationDevice
Subjects will put on a virtual reality rehabilitation system which will present sights and sounds.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group Virtual Reality (VR) Treatment | Experimental | Visual Auditory Virtual Reality rehabilitation for visual hemianopia Receives: Device: Cross-model Visual Auditory Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humphrey Visual Field Perimetry
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.
Measured: Baseline
Humphrey Visual Field Perimetry
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.
Measured: up to 2 Months
Virtual Reality (VR) Visual Field Test--Mean Percent Correct
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.
Measured: Day 1
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 2
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 3
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 4
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 5
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 6
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 7
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 8
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 9
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 10
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 11
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 12
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 13
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 14
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 15
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 16
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 17
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 18
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 19
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 20
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 21
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 22
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 23
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 24
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 25
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 26
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 27
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 28
Virtual Reality Visual Field Test--Mean Percent Correct
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.
Measured: Day 29
Peripheral Visual Field Frame Test
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.
Measured: Baseline
Peripheral Visual Field Frame Test
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.
Measured: up to 2 Months
Peripheral Visual Field Frame Test
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.
Measured: 3 Months
Peripheral Visual Field Frame Test
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.
Measured: 6 Months
Secondary outcomes (35)
National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)--Composite Score
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. This score is calculated from the average of all subscale scores in the NEI VFQ-25 excluding the general health score. The score ranges from 0 to 100. A higher score denotes better vision-related quality of life.
Measured: Baseline, 2 months, 3 months
NEI-VFQ-25--Composite Score
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. This score is calculated from the average of all subscale scores in the NEI VFQ-25 excluding the general health score. The score ranges from 0 to 100. A higher score denotes better vision-related quality of life.
Measured: 6 month
NEI-VFQ-25--General Health Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The General Health Score is a subscale that measures the participant's self-report of their overall health. The score ranges from 0 to 100. A higher score denotes better perception of overall health.
Measured: Baseline, 2 months, 3 months
NEI-VFQ-25--General Health Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The General Health Score is a subscale that measures the participant's self-report of their overall health. The score ranges from 0 to 100. A higher score denotes better perception of overall health.
Measured: 6 months
NEI-VFQ-25--General Vision Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The General Vision Score measures the participant's reported quality of vision. The score ranges from 0 to 100. A higher score denotes a better perception of vision
Measured: Baseline, 2 months, 3 months
NEI-VFQ-25--General Vision Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The General Vision Score measures the participant's reported quality of vision. The score ranges from 0 to 100. A higher score denotes a better perception of vision
Measured: 6 months
NEI-VFQ-25--Ocular Pain Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Ocular Pain Score Subscale measures reported pain or discomfort in and around the eyes. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to ocular pain.
Measured: Baseline, 2 months, 3 months
NEI-VFQ-25--Ocular Pain Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Ocular Pain Score Subscale measures reported pain or discomfort in and around the eyes. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to ocular pain.
Measured: 6 months
NEI-VFQ-25--Near Activities Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Near Activities Score Subscale measures difficulty with performing near activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to near activities.
Measured: Baseline, 2 months, 3 months
NEI-VFQ-25--Near Activities Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Near Activities Score Subscale measures difficulty with performing near activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to near activities.
Measured: 6 months
NEI-VFQ-25--Distance Activities Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Distance Activities Score Subscale measures difficulty with performing distance activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to distance activities.
Measured: Baseline, 2 months, 3 months
NEI-VFQ-25--Distance Activities Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Distance Activities Score Subscale measures difficulty with performing distance activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to distance activities.
Measured: 6 months
NEI-VFQ-25--Social Functioning Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Social Functioning Score Subscale measures how vision difficulties affect social functioning. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to social functioning.
Measured: Baseline, 2 months, 3 months
NEI-VFQ-25--Social Functioning Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Social Functioning Score Subscale measures how vision difficulties affect social functioning. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to social functioning.
Measured: 6 months
NEI-VFQ-25--Mental Health Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Mental Health Score Subscale measures how much patients feel vision affects their mental health. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life relating to mental health.
Measured: Baseline, 2 months, 3 months
NEI-VFQ-25--Mental Health Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Mental Health Score Subscale measures how much patients feel vision affects their mental health. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life relating to mental health.
Measured: 6 months
NEI-VFQ-25--Role Difficulties Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Role Difficulties Score Subscale measures how limited by their vision patients feel they are. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life relating to role difficulties.
Measured: Baseline, 2 months, 3 months
NEI-VFQ-25--Role Difficulties Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Role Difficulties Score Subscale measures how limited by their vision patients feel they are. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life relating to role difficulties.
Measured: 6 months
NEI-VFQ-25--Dependency Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Dependency Score Subscale measures how much patients are dependent on other people due to their vision. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to dependency.
Measured: Baseline, 2 months, 3 months
NEI-VFQ-25--Dependency Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Dependency Score Subscale measures how much patients are dependent on other people due to their vision. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to dependency.
Measured: 6 months
NEI-VFQ-25--Driving Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Driving Score Subscale measures patients' reported difficulty with driving. The score ranges from 0 to 100. Patients who do not drive are not given a driving score. A higher score denotes better vision-specific quality of life related to driving.
Measured: Baseline, 2 months, 3 months
NEI-VFQ-25--Driving Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Driving Score Subscale measures patients' reported difficulty with driving. The score ranges from 0 to 100. Patients who do not drive are not given a driving score. A higher score denotes better vision-specific quality of life related to driving.
Measured: 6 months
NEI-VFQ-25--Color Vision Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Color Vision Score Subscale measures how much difficulty patients have with using color vision to complete daily activities such as picking out clothes. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to color vision.
Measured: Baseline, 2 months, 3 months
NEI-VFQ-25--Color Vision Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Color Vision Score Subscale measures how much difficulty patients have with using color vision to complete daily activities such as picking out clothes. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to color vision.
Measured: 6 months
NEI-VFQ-25--Peripheral Vision Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Peripheral Vision Score Subscale measures how much difficulty patients have with their peripheral vision to complete daily activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to peripheral vision.
Measured: Baseline, 2 months, 3 months
NEI-VFQ-25--Peripheral Vision Score Subscale
The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Peripheral Vision Score Subscale measures how much difficulty patients have with their peripheral vision to complete daily activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to peripheral vision.
Measured: 6 months
Veterans Affairs Low Vision Visual Function Questionnaire-48 (VA LV VFQ-48)--Item Score
The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 (most difficult) and >=-2.22 (least difficult). Scores out of this range indicate something other than visual impairment is governing the patient's responses. The Item Score is the average functional reserve of all the items in the questionnaire excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons). Functional reserve is the difference between a patient's visual ability and the visual ability needed to perform an activity.
Measured: Baseline, 2 months
VA LV VFQ-48--Item Score
The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 (most difficult) and >=-2.22 (least difficult). Scores out of this range indicate something other than visual impairment is governing the patient's responses. The Item Score is the average functional reserve of all the items in the questionnaire excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons). Functional reserve is the difference between a patient's visual ability and the visual ability needed to perform an activity.
Measured: 3 months
VA LV VFQ-48--Item Score
The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 (most difficult) and >=-2.22 (least difficult). Scores out of this range indicate something other than visual impairment is governing the patient's responses. The Item Score is the average functional reserve of all the items in the questionnaire excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons). Functional reserve is the difference between a patient's visual ability and the visual ability needed to perform an activity.
Measured: 6 months
VA LV VFQ-48--Composite Score
The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 and >=-2.22. Scores out of this range indicate something other than visual impairment is governing the patient's responses. The reading domain score is calculated by calculating the average score of reading items. The composite score approximates a person's visual ability. The score is calculated using Massof's algorithm using the inverse hyperbolic tangent equation. For the composite score, a lower score is better.
Measured: Baseline, 2 months
VA LV VFQ-48--Composite Score
he VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 and >=-2.22. Scores out of this range indicate something other than visual impairment is governing the patient's responses. The reading domain score is calculated by calculating the average score of reading items. The composite score approximates a person's visual ability. The score is calculated using Massof's algorithm using the inverse hyperbolic tangent equation. For the composite score, a lower score is better.
Measured: 3 months
VA LV VFQ-48--Composite Score
he VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 and >=-2.22. Scores out of this range indicate something other than visual impairment is governing the patient's responses. The reading domain score is calculated by calculating the average score of reading items. The composite score approximates a person's visual ability. The score is calculated using Massof's algorithm using the inverse hyperbolic tangent equation. For the composite score, a lower score is better.
Measured: 6 months
VA LV VFQ-48--Reading Domain Score
The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The reading domain score is calculated by calculating the average score of reading items. Scores range from 0 to 3.5 logits, with higher scores denoting better ability to perform activities. The Reading Domain Score is the average functional reserve of the items measuring the reading functional domain, excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons).
Measured: Baseline, 2 months
VA LV VFQ-48--Reading Domain Score
The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The reading domain score is calculated by calculating the average score of reading items. Scores range from 0 to 3.5 logits, with higher scores denoting better ability to perform activities. The Reading Domain Score is the average functional reserve of the items measuring the reading functional domain, excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons).
Measured: 3 months
VA LV VFQ-48--Reading Domain Score
The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The reading domain score is calculated by calculating the average score of reading items. Scores range from 0 to 3.5 logits, with higher scores denoting better ability to perform activities. The Reading Domain Score is the average functional reserve of the items measuring the reading functional domain, excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start29 Jun 2020
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hemianopia, HomonymousStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All study participants will be given the same treatment.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huai Jiang, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230486
- Sponsor's protocol ID
- IRB00061542
- Status last verified
- Feb 2022
- First submitted
- 14 Jan 2020
- Last updated
- 30 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All of the individual participant data that underlie the results reported in the publication will be shared after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality System for Cross-modal Rehabilitation of Hemianopia
- ClinicalTrials.gov ID
- NCT04230486
- Acronym / sponsor ID
- IRB00061542
- Conditions
- Hemianopia, Homonymous, Hemianopsia, Homonymous
- Keywords
- Hemianopia, Virtual Reality, Rehabilitation, Hemianopsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Posted 30 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All study participants will be given the same treatment.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group Virtual Reality (VR) Treatment | Experimental | Device: Cross-model Visual Auditory RehabilitationVisual Auditory Virtual Reality rehabilitation for visual hemianopia |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult volunteers diagnosed with homonymous visual hemianopia / hemianopsia (ages 18-99)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross-model Visual Auditory RehabilitationSubjects will put on a virtual reality rehabilitation system which will present sights and sounds. | Device | Experimental Group Virtual Reality (VR) Treatment |
Primary outcome
Humphrey Visual Field Perimetry
Time frame: Baseline
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.
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 (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.
Virtual Reality Visual Field Test--Mean Percent Correct
Time frame: Day 2
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 Visual Field Test--Mean Percent Correct
Time frame: Day 3
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 Visual Field Test--Mean Percent Correct
Time frame: Day 4
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 Visual Field Test--Mean Percent Correct
Time frame: Day 5
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 Visual Field Test--Mean Percent Correct
Time frame: Day 6
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 Visual Field Test--Mean Percent Correct
Time frame: Day 7
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 Visual Field Test--Mean Percent Correct
Time frame: Day 8
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 Visual Field Test--Mean Percent Correct
Time frame: Day 9
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 Visual Field Test--Mean Percent Correct
Time frame: Day 10
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 Visual Field Test--Mean Percent Correct
Time frame: Day 11
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 Visual Field Test--Mean Percent Correct
Time frame: Day 12
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 Visual Field Test--Mean Percent Correct
Time frame: Day 13
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 Visual Field Test--Mean Percent Correct
Time frame: Day 14
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 Visual Field Test--Mean Percent Correct
Time frame: Day 15
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 Visual Field Test--Mean Percent Correct
Time frame: Day 16
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 Visual Field Test--Mean Percent Correct
Time frame: Day 17
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 Visual Field Test--Mean Percent Correct
Time frame: Day 18
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 Visual Field Test--Mean Percent Correct
Time frame: Day 19
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 Visual Field Test--Mean Percent Correct
Time frame: Day 20
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 Visual Field Test--Mean Percent Correct
Time frame: Day 21
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 Visual Field Test--Mean Percent Correct
Time frame: Day 22
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 Visual Field Test--Mean Percent Correct
Time frame: Day 23
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 Visual Field Test--Mean Percent Correct
Time frame: Day 24
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 Visual Field Test--Mean Percent Correct
Time frame: Day 25
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 Visual Field Test--Mean Percent Correct
Time frame: Day 26
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 Visual Field Test--Mean Percent Correct
Time frame: Day 27
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 Visual Field Test--Mean Percent Correct
Time frame: Day 28
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 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.
Peripheral Visual Field Frame Test
Time frame: Baseline
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.
Peripheral Visual Field Frame Test
Time frame: up to 2 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.
Peripheral Visual Field Frame Test
Time frame: 3 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.
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.
35 secondary outcomes
National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)--Composite Score
Time frame: Baseline, 2 months, 3 months
NEI-VFQ-25--Composite Score
Time frame: 6 month
NEI-VFQ-25--General Health Score Subscale
Time frame: Baseline, 2 months, 3 months
NEI-VFQ-25--General Health Score Subscale
Time frame: 6 months
NEI-VFQ-25--General Vision Score Subscale
Time frame: Baseline, 2 months, 3 months
NEI-VFQ-25--General Vision Score Subscale
Time frame: 6 months
NEI-VFQ-25--Ocular Pain Score Subscale
Time frame: Baseline, 2 months, 3 months
NEI-VFQ-25--Ocular Pain Score Subscale
Time frame: 6 months
NEI-VFQ-25--Near Activities Score Subscale
Time frame: Baseline, 2 months, 3 months
NEI-VFQ-25--Near Activities Score Subscale
Time frame: 6 months
NEI-VFQ-25--Distance Activities Score Subscale
Time frame: Baseline, 2 months, 3 months
NEI-VFQ-25--Distance Activities Score Subscale
Time frame: 6 months
NEI-VFQ-25--Social Functioning Score Subscale
Time frame: Baseline, 2 months, 3 months
NEI-VFQ-25--Social Functioning Score Subscale
Time frame: 6 months
NEI-VFQ-25--Mental Health Score Subscale
Time frame: Baseline, 2 months, 3 months
NEI-VFQ-25--Mental Health Score Subscale
Time frame: 6 months
NEI-VFQ-25--Role Difficulties Score Subscale
Time frame: Baseline, 2 months, 3 months
NEI-VFQ-25--Role Difficulties Score Subscale
Time frame: 6 months
NEI-VFQ-25--Dependency Score Subscale
Time frame: Baseline, 2 months, 3 months
NEI-VFQ-25--Dependency Score Subscale
Time frame: 6 months
NEI-VFQ-25--Driving Score Subscale
Time frame: Baseline, 2 months, 3 months
NEI-VFQ-25--Driving Score Subscale
Time frame: 6 months
NEI-VFQ-25--Color Vision Score Subscale
Time frame: Baseline, 2 months, 3 months
NEI-VFQ-25--Color Vision Score Subscale
Time frame: 6 months
NEI-VFQ-25--Peripheral Vision Score Subscale
Time frame: Baseline, 2 months, 3 months
NEI-VFQ-25--Peripheral Vision Score Subscale
Time frame: 6 months
Veterans Affairs Low Vision Visual Function Questionnaire-48 (VA LV VFQ-48)--Item Score
Time frame: Baseline, 2 months
VA LV VFQ-48--Item Score
Time frame: 3 months
VA LV VFQ-48--Item Score
Time frame: 6 months
VA LV VFQ-48--Composite Score
Time frame: Baseline, 2 months
VA LV VFQ-48--Composite Score
Time frame: 3 months
VA LV VFQ-48--Composite Score
Time frame: 6 months
VA LV VFQ-48--Reading Domain Score
Time frame: Baseline, 2 months
VA LV VFQ-48--Reading Domain Score
Time frame: 3 months
VA LV VFQ-48--Reading Domain Score
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All of the individual participant data that underlie the results reported in the publication will be shared after deidentification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huai Jiang, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross-model Visual Auditory Rehabilitation in people with Hemianopia, Homonymous and Hemianopsia, Homonymous, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humphrey Visual Field Perimetry (time frame: Baseline). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.