Convergence InsufficiencyPhase 1NCT06886737
Home-based Vision Therapy
A Phase 1 study testing Virtual-reality convergence training game in people with Convergence Insufficiency, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Convergence Insufficiency
- What is being tested?
- Virtual-reality convergence training game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2026to 30 Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Convergence insufficiency (VR-NPC < 32 deg)
Who cannot join
- Neurological condition other than TBI that would affect convergence
- History of strabismus, amblyopia, or other binocular vision issues prior to TBI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
Mark F Walker, MD, (216) 791-3800 ext. 820 5225, Mark.Walker5@va.gov
Mark F. Walker, MD
About this study
Official title: Home-based Treatment of Binocular Eye Dysfunction in Veterans With Traumatic Brain Injury
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.
- Conditions
- Convergence Insufficiency
- Being tested
- Virtual-reality convergence training game
- Keywords
- Vision, Binocular, Convergence, Ocular
- Medical subject headings
- Ocular Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual-reality convergence training gameOther
The participant plays a custom virtual-reality game that is designed to train convergence.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Intervention block followed by non-intervention block Receives: Other: Virtual-reality convergence training game |
| Group B | Experimental | Non-intervention block followed by intervention block Receives: Other: Virtual-reality convergence training game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vergence Capacity (VR-NPC)
The near point of convergence (angle of maximum ocular convergence) will be measured using a custom virtual-reality application.
Measured: 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.
Measured: 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.
Measured: At completion of active treatment block (six-weeks duration)
Secondary outcomes (10)
Accommodation
Ocular accommodation (focus of the intraocular lens for near viewing) will be measured using the minus-lens method.
Measured: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)
Dynamic Vergence
The accuracy and speed of fixation steps between virtual near and far targets is assessed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start14 Jan 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Convergence InsufficiencyStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mark F. Walker, MD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886737
- Sponsor's protocol ID
- N5317-R
- Status last verified
- Jan 2026
- First submitted
- 7 Mar 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Treatment of Binocular Eye Dysfunction in Veterans With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06886737
- Acronym / sponsor ID
- N5317-R
- Conditions
- Convergence Insufficiency
- Keywords
- Vision, Binocular, Convergence, Ocular
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Virtual-reality convergence training gameIntervention block followed by non-intervention block |
| Group B | Experimental | Other: Virtual-reality convergence training gameNon-intervention block followed by intervention block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Convergence insufficiency (VR-NPC < 32 deg)
Key exclusion criteria (2 listed)
- Neurological condition other than TBI that would affect convergence
- History of strabismus, amblyopia, or other binocular vision issues prior to TBI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual-reality convergence training gameThe participant plays a custom virtual-reality game that is designed to train convergence. | Other | Group A, Group B |
Primary outcome
Vergence Capacity (VR-NPC)
Time frame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)
The near point of convergence (angle of maximum ocular convergence) will be measured using a custom virtual-reality application.
System Usability Scale (SUS)
Time frame: At completion of active treatment block (six-weeks duration)
This is a standardized questionnaire to assess how easy a new technology is to use.
Simulator Sickness Questionnaire (SSQ)
Time frame: At completion of active treatment block (six-weeks duration)
This is a standardized questionnaire to test the player's tolerance of the virtual-reality experience.
10 secondary outcomes
Accommodation
Time frame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)
Dynamic Vergence
Time frame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)
Stereoacuity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At study onset, At completion of Block 2 (six weeks duration)
WIAT Word Reading Test: Word Fluency Score
Time frame: At study onset, At completion of Block 2 (six weeks duration)
WIAT Oral Reading Fluency and Comprehension Test: Oral Reading Accuracy Score
Time frame: At study onset, At completion of Block 2 (six weeks duration)
WIAT Oral Reading Fluency and Comprehension Test: Oral Reading Fluency Score
Time frame: At study onset, At completion of Block 2 (six weeks duration)
Convergence Insufficiency Symptom Survey (CISS)
Time frame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Validation of Clinical Outcome Measures Specific to mTBI-Related Oculomotor Disorders
MTBI - Mild Traumatic Brain Injury
Not yet recruiting
Effect of Oculomotor Therapy in Individuals With Convergence Insufficiency
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Active, not recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark F. Walker, MD principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Virtual-reality convergence training game in people with Convergence Insufficiency, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark F Walker, MD ((216) 791-3800 ext. 820 5225, Mark.Walker5@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vergence Capacity (VR-NPC) (time frame: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.