Home-based Vision Therapy
ConditionConvergence Insufficiency
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
U.S. Military Veteran
Place of residence within driving distance of Cleveland, OH
Clinical eye exam within 6 months prior to enrollment and since the most recent TBI (if applicable) and the onset of near vision symptoms (if applicable)
Best-corrected visual acuity 20/25 or better in each eye
Disqualifiers
Neurological condition other than TBI that would affect convergence
History of strabismus, amblyopia, or other binocular vision issues prior to TBI
Trial design
Design model
Crossover
Treatments tested in this trial
Virtual-reality convergence training game
Other interventionThe participant plays a custom virtual-reality game that is designed to train convergence.
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Vergence Capacity (VR-NPC)
The near point of convergence (angle of maximum ocular convergence) will be measured using a custom virtual-reality application.
Time frame
At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)2
System Usability Scale (SUS)
This is a standardized questionnaire to assess how easy a new technology is to use.
Time frame
At completion of active treatment block (six-weeks duration)3
Simulator Sickness Questionnaire (SSQ)
This is a standardized questionnaire to test the player's tolerance of the virtual-reality experience.
Time frame
At completion of active treatment block (six-weeks duration)Secondary outcomes
1
Accommodation
Ocular accommodation (focus of the intraocular lens for near viewing) will be measured using the minus-lens method.
Time frame
At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)2
Dynamic Vergence
The accuracy and speed of fixation steps between virtual near and far targets is assessed.
Time frame
At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)3
Stereoacuity
Stereovision is assessed in virtual reality. Stereoacuity threshold is determined from a curve fit to the response data.
Time frame
At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)4
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.
Time frame
At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)Sponsors and contacts
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Source ClinicalTrials.gov