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Post-concussive vision symptoms affect many Veterans who have experienced traumatic brain injury (TBI). One common issue is trouble with near vision, a problem that may persist long after the acute injury. Double vision or difficulty focusing on close objects can affect reading and depth perception. Poor reading can interfere with academic or work performance, and loss of near focusing can affect jobs that require fine motor tasks like machining and electrical work. Even having trouble using a smartphone can have a substantial impact on both work and social function. Near vision impairment after TBI is not well understood, and treatments are limited. The goal of this project is to investigate novel virtual-reality assessments and training games to improve the near vision diagnosis and home-based rehabilitation. Restoring normal near vision function could have a large impact on the fulfillment of Veterans' educational, career, and overall life goals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Intervention block followed by non-intervention block |
|
| Group B | Experimental | Non-intervention block followed by intervention block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual-reality convergence training game | Other | The participant plays a custom virtual-reality game that is designed to train convergence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vergence Capacity (VR-NPC) | The near point of convergence (angle of maximum ocular convergence) will be measured using a custom virtual-reality application. | At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration) |
| System Usability Scale (SUS) | This is a standardized questionnaire to assess how easy a new technology is to use. | At completion of active treatment block (six-weeks duration) |
| Simulator Sickness Questionnaire (SSQ) | This is a standardized questionnaire to test the player's tolerance of the virtual-reality experience. | At completion of active treatment block (six-weeks duration) |
| Measure | Description | Time Frame |
|---|---|---|
| Accommodation | Ocular accommodation (focus of the intraocular lens for near viewing) will be measured using the minus-lens method. | At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration) |
| Dynamic Vergence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark F Walker, MD | Contact | (216) 791-3800 | 820 5225 | Mark.Walker5@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Mark F. Walker, MD | Louis Stokes VA Medical Center, Cleveland, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Stokes VA Medical Center, Cleveland, OH | Recruiting | Cleveland | Ohio | 44106-1702 | United States |
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| ID | Term |
|---|---|
| D015835 | Ocular Motility Disorders |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |
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Participants perform convergence exercises at home in the form of a custom virtual-reality game. The trial is divided into two 6-week blocks, one for active treatment and one for no treatment. Participants will be randomized into the treatment-first or treatment-second arm.
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The accuracy and speed of fixation steps between virtual near and far targets is assessed. |
| At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration) |
| Stereoacuity | Stereovision is assessed in virtual reality. Stereoacuity threshold is determined from a curve fit to the response data. | At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration) |
| VR Word Reading: Word Accuracy Score | The accuracy and speed of word reading is assessed in response to lists of words presented to the participant in virtual reality. The Word Accuracy Score is the number of words read correctly minus errors. | At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration) |
| VR Word Reading: Reading Speed Score | The accuracy and speed of word reading is assessed in response to lists of words presented to the participant in virtual reality. The Reading Speed Score is the Word Accuracy Score divided by total reading time. | At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration) |
| WIAT Word Reading Tests: Word Accuracy Score | Participants read lists of words and nonsense words. The number of words read correctly is the accuracy score. Raw score will be converted to a standardized score (mean=100, S.D.=15) using normative data. | At study onset, At completion of Block 2 (six weeks duration) |
| WIAT Word Reading Test: Word Fluency Score | Participant reads lists of words and nonsense words. The number of words read correctly within 30 seconds is the fluency score. Raw score will be converted to a standardized score (mean=100, S.D.=15) using normative data. | At study onset, At completion of Block 2 (six weeks duration) |
| WIAT Oral Reading Fluency and Comprehension Test: Oral Reading Accuracy Score | Participant reads two passages aloud. The Oral Reading Accuracy Score is the number of words read minus errors (mispronunciations or additions). Raw score will be converted to a standardized score (mean=100, S.D.=15) using normative data. | At study onset, At completion of Block 2 (six weeks duration) |
| WIAT Oral Reading Fluency and Comprehension Test: Oral Reading Fluency Score | Participant reads two passages aloud. The Oral Reading Fluency Score is the Oral Reading Accuracy Score (Outcome #9) divided by the time needed to complete reading of the passage. Raw score will be converted to a standardized score (mean=100, S.D.=15) using normative data. | At study onset, At completion of Block 2 (six weeks duration) |
| Convergence Insufficiency Symptom Survey (CISS) | This is a standardized questionnaire to assess symptoms related to near vision. | At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration) |