An interventional study of Cross-model Visual Auditory Rehabilitation in Hemianopia, Homonymous and Hemianopsia, Homonymous, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-11-30.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
63 studies on the registry are indexed under Hemianopsia; 24 are open to participants now.
This study's enrollment of 6 is below the median of 32 across 53 interventional studies indexed under Hemianopsia.
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Exclusion Criteria:
Visual Auditory Virtual Reality rehabilitation for visual hemianopia
Device: Cross-model Visual Auditory Rehabilitation
Subjects will put on a virtual reality rehabilitation system which will present sights and sounds.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 Months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 6 months
Grating Acuity Test
Change in the percentage of correctly identified trials.
Time frame: First visit after the completion of rehabilitation (1 or 2 months)
Color Vision Test
Change in the percentage of correctly identified trials for each color.
Time frame: First visit after the completion of rehabilitation (1 or 2 months)
Shape Recognition Test
Change in the percentage of correctly identified trials.
Time frame: First visit after the completion of rehabilitation (1 or 2 months)
Six subjects signed consent. One screen failed.
| Milestone | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Started | 6 |
| Completed | 5 |
| Not completed | 1 |
| Withdrew: Screen failure | 1 |
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.
| visual angle degrees^2 | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| Humphrey Visual Field Perimetry | 108 ± 198.49 | 1272 ± 117.58 |
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.
| visual angle degrees^2 | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| Humphrey Visual Field Perimetry | 594 ± 542.99 | 1356 ± 18.59 |
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 0 ± 0 | 91.667 ± 11.785 |
| 30 Degrees | 8.33 ± 11.785 | 100 ± 0 |
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 16.667 ± 23.57 | 100 ± 0 |
| 30 Degrees | 0 ± 0 | 100 ± 0 |
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 8.333 ± 11.785 | 100 ± 0 |
| 30 Degrees | 0 ± 0 | 100 ± 0 |
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 0 ± 0 | 100 ± 0 |
| 30 Degrees | 0 ± 0 | 100 ± 0 |
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 0 ± 0 | 100 ± 0 |
| 30 Degrees | 8.333 ± 11.785 | 100 ± 0 |
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 50 ± 70.711 | 100 ± 0 |
| 30 Degrees | 8.333 ± 11.785 | 100 ± 0 |
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 58.333 ± 35.355 | 100 ± 0 |
| 30 Degrees | 8.333 ± 11.785 | 100 ± 0 |
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.
No measurements were reported for this outcome.
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 50 ± 70.711 | 100 ± 0 |
| 30 Degrees | 8.333 ± 11.785 | 100 ± 0 |
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 50 ± 70.711 | 100 ± 0 |
| 30 Degrees | 8.333 ± 11.785 | 100 ± 0 |
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.
No measurements were reported for this outcome.
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 50 ± 70.711 | 100 ± 0 |
| 30 Degrees | 8.33 ± 11.785 | 91.667 ± 11.785 |
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 41.667 ± 58.926 | 100 ± 0 |
| 30 Degrees | 8.333 ± 11.785 | 100 ± 0 |
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 58.333 ± 58.926 | 100 ± 0 |
| 30 Degrees | 8.333 ± 11.785 | 100 ± 0 |
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 50 ± 70.711 | 91.667 ± 11.785 |
| 30 Degrees | 8.333 ± 11.785 | 100 ± 0 |
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 50 ± 70.711 | 100 ± 0 |
| 30 Degrees | 0 ± 0 | 100 ± 0 |
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 50 ± 70.711 | 100 ± 0 |
| 30 Degrees | 0 ± 0 | 100 ± 0 |
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 50 ± 70.711 | 100 ± 0 |
| 30 Degrees | 0 ± 0 | 100 ± 0 |
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 50 ± 70.711 | 100 ± 0 |
| 30 Degrees | 0 ± 0 | 91.667 ± 11.785 |
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 50 ± 70.711 | 100 ± 0 |
| 30 Degrees | 8.333 ± 11.785 | 100 ± 0 |
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.
No measurements were reported for this outcome.
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 50 ± 47.14 | 100 ± 0 |
| 30 Degrees | 41.667 ± 58.926 | 91.667 ± 11.785 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 66.667 ± 47.14 | 100 ± 0 |
| 30 Degrees | 58.333 ± 58.926 | 100 ± 0 |
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 50 ± 70.711 | 100 ± 0 |
| 30 Degrees | 50 ± 70.711 | 100 ± 0 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
| percentage of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 66.667 ± 47.14 | 100 ± 0 |
| 30 Degrees | 50 ± 70.711 | 100 ± 0 |
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.
| Percent of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 20 ± 44.7214 | 80 ± 44.7214 |
| 30 Degrees | 20 ± 44.7214 | 80 ± 44.7214 |
| 45 Degrees | 20 ± 44.7214 | 80 ± 44.7214 |
| 60 Degrees | 20 ± 44.7214 | 72 ± 43.8178 |
| 75 Degrees | 0 ± 0 | 76 ± 43.359 |
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.
| Percent of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 100 ± 0 | 80 ± 44.7214 |
| 30 Degrees | 96 ± 8.9443 | 96 ± 8.9443 |
| 45 Degrees | 92 ± 17.8885 | 100 ± 0 |
| 60 Degrees | 80 ± 44.7214 | 100 ± 0 |
| 75 Degrees | 60 ± 54.7723 | 92 ± 17.8885 |
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.
| Percent of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 95 ± 10 | 90 ± 20 |
| 30 Degrees | 90 ± 20 | 90 ± 20 |
| 45 Degrees | 80 ± 40 | 100 ± 0 |
| 60 Degrees | 75 ± 50 | 100 ± 0 |
| 75 Degrees | 65 ± 47.2582 | 100 ± 0 |
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.
| Percent of correct trials | Virtual Reality (VR) Treatment--Deficit Eye | Virtual Reality (VR) Treatment-Intact |
|---|---|---|
| 15 Degrees | 100 | 100 |
| 30 Degrees | 100 | 100 |
| 45 Degrees | 100 | 100 |
| 60 Degrees | 100 | 100 |
| 75 Degrees | 100 | 100 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Baseline | 60.793 ± 19.498 |
| 2 months | 68.621 ± 21.932 |
| 3 months | 69.893 ± 29.418 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| NEI-VFQ-25--Composite Score | 85.87 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Baseline | 68.75 ± 37.5 |
| 2 months | 68.75 ± 31.458 |
| 3 months | 62.5 ± 17.678 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| NEI-VFQ-25--General Health Score Subscale | 50 |
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
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Baseline | 65 ± 19.149 |
| 2 months | 60 ± 28.284 |
| 3 months | 70 ± 14.142 |
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
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| NEI-VFQ-25--General Vision Score Subscale | 80 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Baseline | 90.625 ± 6.25 |
| 2 months | 90.625 ± 11.968 |
| 3 months | 81.25 ± 26.517 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| NEI-VFQ-25--Ocular Pain Score Subscale | 100 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Baseline | 56.25 ± 22.948 |
| 2 months | 60.417 ± 31.458 |
| 3 months | 75 ± 11.785 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| NEI-VFQ-25--Near Activities Score Subscale | 75 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Baseline | 48.333 ± 18.609 |
| 2 months | 76.25 ± 19.167 |
| 3 months | 77.5 ± 20.035 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| NEI-VFQ-25--Distance Activities Score Subscale | 75 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Baseline | 55 ± 24.495 |
| 2 months | 70.625 ± 35.259 |
| 3 months | 87.5 ± 17.678 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| NEI-VFQ-25--Social Functioning Score Subscale | 87.5 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Baseline | 51.563 ± 32.022 |
| 2 months | 48.4375 ± 35.858 |
| 3 months | 56.25 ± 61.872 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| NEI-VFQ-25--Mental Health Score Subscale | 98.73 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Baseline | 62.5 ± 32.275 |
| 2 months | 65.625 ± 11.968 |
| 3 months | 50 ± 70.711 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| NEI-VFQ-25--Role Difficulties Score Subscale | 100 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Baseline | 41.667 ± 35.355 |
| 2 months | 50 ± 41.388 |
| 3 months | 62.5 ± 53.033 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| NEI-VFQ-25--Dependency Score Subscale | 100 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| 3 months | 83.333 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| NEI-VFQ-25--Driving Score Subscale | 58.33 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Baseline | 75 ± 20.412 |
| 2 months | 87.5 ± 14.434 |
| 3 months | 87.5 ± 17.678 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| NEI-VFQ-25--Color Vision Score Subscale | 100 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Baseline | 50 ± 35.3554 |
| 2 months | 81.25 ± 37.5 |
| 3 months | 62.5 ± 17.678 |
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.
| score on a scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| NEI-VFQ-25--Peripheral Vision Score Subscale | 75 |
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.
| Score on a Scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Baseline | 1.248 ± 0.898 |
| 2 Months | 1.704 ± 0.948 |
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.
| Score on a Scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| VA LV VFQ-48--Item Score | 2.063 |
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.
| Score on a Scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| VA LV VFQ-48--Item Score | 1.955 |
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.
| Score on a Scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Baseline | -1.607 ± 1.923 |
| 2 Months | -2.481 ± 1.834 |
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.
| Score on a Scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| VA LV VFQ-48--Composite Score | -2.415 |
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.
| Score on a Scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| VA LV VFQ-48--Composite Score | -2.095 |
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).
| Score on a Scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Baseline | 1.839 ± 1.050 |
| 2 Months | 2.230 ± 0.982 |
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).
| Score on a Scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| VA LV VFQ-48--Reading Domain Score | 2.673 |
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).
| Score on a Scale | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| VA LV VFQ-48--Reading Domain Score | 2.549 |
Change in the percentage of correctly identified trials.
Results for this outcome have not been posted.
Change in the percentage of correctly identified trials for each color.
Results for this outcome have not been posted.
Change in the percentage of correctly identified trials.
Results for this outcome have not been posted.
Collected over Baseline through 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental Group Virtual Reality (VR) Treatment | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
Analysis population includes only subjects who met screening criteria.
| Age, Continuous(years) | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Mean | 62.6 ± 13.667 |
| Sex: Female, Male(Participants) | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Female | 4 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Experimental Group Virtual Reality (VR) Treatment |
|---|---|
| United States | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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)
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be made available immediately following publication for five years.
Access criteria: Anyone who wishes to access the data for any purpose.
Data sharing details ↗ · github.com
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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