Medical Policy

This document addresses devices that evaluate eye movement analysis to aid in the diagnosis of concussion. The EyeBOX^® (Oculogica, Inc. [New York, NY]), is the first baseline-free, eye movement analysis device to assist physicians in objectively evaluating individuals with suspected concussion.

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

Investigational and Not Medically Necessary:

Eye movement analysis using non-spatial calibration is considered investigational and not medically necessary for the diagnosis of concussion.

This document describes clinical studies and expert recommendations, and explains whether devices that evaluate eye movement to detect the presence of a concussion are clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Eye tracking tests, including devices like EyeBOX, measure how the eyes move while a person watches a screen. These tests are being studied as a way to help diagnose concussion, also called mild traumatic brain injury. A concussion can affect thinking, balance, vision, and mood. Current tools like symptom checks, exams, and CT scans do not always detect concussion well. Eye tracking may offer a quick way to look for changes in brain function.

What the Studies Show

Eye movement problems are common after brain injury. Studies show that people with concussion may have slower or less accurate eye movements. Some research found that eye tracking can detect these differences and may relate to symptom severity. For example, people with concussion may have trouble following moving objects or may show uneven eye movement between the two eyes.

Devices like EyeBOX use video and sensors to measure eye movement and give a score. Some studies show moderate accuracy, but results vary. In some cases, the test correctly identified concussion about 80 percent of the time, but also gave false results. Other studies found that results may differ based on age, type of injury, or timing after injury. Results may also overlap between people with and without concussion, and results can be positive in people without concussion and negative in people who do have one. Experts note that many studies are small or limited to certain groups, such as athletes or teens. Also, some studies may have bias or conflicts of interest. At this time, the available studies show that while eye tracking can detect differences in eye movement, it is not accurate enough to diagnose concussion on its own. Research is limited, and many studies include small or specific groups, which makes results less reliable. Experts state that there is not enough research to confirm that these tests are useful in real-world care. Overall, better studies are needed to know if these tests improve health or decision making.

Is this clinically appropriate?

Eye tracking tests, including EyeBOX, are not appropriate because they have not been proven to improve health.

Using tests that are not proven to be accurate and impact health outcomes can lead to needless worry, or to treatment that does not help. There is also a risk of false results, which could delay proper care or lead to unnecessary testing.

(Return to Description/Scope)

Summary

Although preliminary research exploring the use of eye movement analysis using non-spatial calibration to diagnose concussion appears promising, at this time there are very few published clinical studies, and the clinical utility of this technology is unproven. While there are some studies that suggest oculomotor dysfunction is present in some individuals with brain injury, there is a lack of peer-reviewed studies demonstrating that eye movement analysis using non-spatial calibration can be used to accurately and reliably diagnose concussion. Further well-designed studies on non-spatial eye movement analysis are needed to draw conclusions about the clinical utility of this technology.

Discussion

Diagnosis of Concussion

Concussion occurs following direct or indirect external trauma to the head that causes a change in brain function. Concussion can affect a variety of clinical domains: physical, cognitive, and behavioral or emotional. The various neurological signs and symptoms of concussion may be nonspecific, subtle and transient, and may persist beyond the usual recovery timeframe. Alterations in balance, as well as cognitive or sensory disturbance, may pre-dispose the affected individual to further injury in the future (Stuart, 2020).

Diagnosis of a concussion can be challenging because there is currently no generally accepted definition or diagnostic criteria and no single assessment has been accepted as being able to identify those with a concussion. Most individuals with a suspected head injury are examined using the 15-point Glasgow Coma Scale (GCS). However, the GCS is based on symptoms and is neither sufficiently sensitive to assess cognitive and neuropsychiatric deficits of concussion nor predictive of outcome. In addition to GCS evaluation, an individual suspected of having sustained a concussion will generally also undergo a CT scan of the head to detect brain tissue damage or intracranial lesions. However, a majority of individuals evaluated for concussion do not have detectable intracranial lesions after having a CT scan. Physicians must therefore rely on expert guidelines and available assessment tools and clinical judgment for concussion diagnosis. Availability of a non-invasive, radiation sparing test for concussion will help health care professionals determine the need for a CT scan in individuals suspected of having a concussion and help prevent unnecessary neuroimaging and associated radiation exposure. In recognition of the need for more concise and accurate assessment tools, researchers are exploring the use of eye tracking technology to aid in the diagnosis of concussion.

Association of Oculomotor Dysfunction with Brain Injury

A TBI can result in a variety of visual disturbances with many individuals exhibiting multiple visual defects in combination with a decline in overall health. Inasmuch as 6 of the 12 cranial nerves directly bear on the visual process, it is not surprising that numerous symptoms of oculomotor dysfunction might be reported in individuals who have sustained a TBI. Defects in primary vision such as visual acuity and visual fields, eye movement disorders including vergence, saccadic and smooth pursuit movements, and in more complex aspects of vision involving visual perception, motion vision, and visuo‐spatial function, have all been reported in TBI. Eye movement dysfunction may be an early sign of TBI (Armstrong, 2018).

Cifu and colleagues (2015) conducted a study to determine whether computerized eye tracking could provide a more objective measure to diagnose and to monitor improvement of symptoms following a concussion. Eye-tracking data, collected via a head-mounted, video-based binocular eye tracker, was used to examine saccades (rapid movements of the eyes that abruptly change the point of focus), fixations, and smooth pursuit movement in a group of 60 military service members with postconcussive syndrome and a control group of 26 asymptomatic participants, in order to determine if eye movement differences could be found and quantified. The diagnosis of concussion was confirmed by the study physiatrist’s history, a review of medical records, and physical examination. Different features of saccades, fixation, and smooth pursuit eye movements were analyzed. Participants with symptomatic concussion had statistically larger position errors, smaller saccadic amplitudes, smaller predicted peak velocities, smaller peak accelerations, and lengthier durations. Individuals with symptomatic concussion were also less likely to follow a target movement (fewer primary saccades). Overall, symptomatic concussion tracked the stepwise moving targets less accurately, revealing possible brain dysfunction. The authors concluded that this investigation represents an important initial step in the understanding of the role of both eye movement abnormalities and computerized eye tracking in the diagnosis and monitoring of symptomatic concussion, but additional studies investigating specific linkages between symptoms, eye-tracking abnormalities, and neuropathology are needed.

In 2018, Howell and colleagues presented the results of a cross-sectional and multisite study to measure eye tracking performance of athletes who were diagnosed with a concussion and uninjured controls. Individuals who reported to two tertiary care sport concussion clinics within 10 days of concussion completed an objective eye tracking assessment. Only individuals who sustained a concussion during sports or by a mechanism involving forces similar to sports, such as being injured during recreational activities or falling from ground level, were included in the study. Participants with more severe injury mechanisms, such as falling from a height or sustaining motor vehicle collisions, were excluded. Researchers identified and recruited healthy adolescent control participants between the ages of 11 and 18 years who were involved in a program at a sports injury prevention center or were children of hospital employees. No spatial calibration was used for tracking eye movement. A total of 79 participants completed the study, 44 with concussion (mean age = 14.1 ± 2.2 years, 39% female) and 35 controls (mean age = 14.3 ± 2.4 years, 57% female). Right eye skew along the bottom of the screen was significantly higher for the concussion cohort compared to controls (median = 0.022 [interquartile range = -0.263, 0.482] vs. 0.377 [interquartile range = -0.574, -0.031]; p=0.002), but not the left eye. Among the variables explored, right eye skew was altered for adolescents with a concussion. The authors concluded that the use of objective eye-tracking technology that can quickly identify individuals with vision-specific disturbances after concussion may allow for earlier recognition of deficits soon after injury and allow for earlier specialist referral and intervention. Because participants in this study reported for care after a concussion to one of two specialized sport concussion clinics associated with a regional tertiary care hospital, findings from this cohort of individuals may not be generalizable to other populations of individuals with concussion.

In a 2021 study, Oldham and colleagues reported the results of a study which examined the relationship between self-reported symptoms and concussion-related eye tracking impairments. The study design included three arms that compared gait performance between (a) adolescents with a concussion who have normal eye tracking, (b) adolescents with a concussion who have abnormal eye tracking, and (c) healthy controls. Eye tracking and gait assessments were completed on a total of 30 concussed participants (age: 14.4 ± 2.2 years, mean ± SD, 50% female) and 30 controls (age: 14.2 ± 2.2 years, 47% female). All eye tracking was binocular, and no spatial calibration was used to allow for the independent analysis of both pupils. The BOX score (a metric of pupillary disconjugacy) was used to quantify oculomotor dysfunction. Symptoms were gathered using the Post-Concussion Symptom Scale (PCSS), and gait speed was measured using triaxial inertial measurement units. The authors reported a significant association between total PCSS score and BOX score in the concussion group (β = 0.16, p=0.004, 95% confidence interval [CI]: 0.06-0.27), but this association was not seen in the control group (β = 0.21, p=0.08, 95%CI: -0.03 to 0.45). No significant associations between PCSS symptom profiles and BOX scores were observed in the concussion or control cohorts. Additionally, there were no significant differences in single-task or dual-task gait speed. The concussed cohort with impaired eye tracking reported higher total symptom severity, as well as worse symptom severity across the five PCSS symptom domain profiles. However, eye tracking deficits did not appear to be caused by any specific symptom domain. The diminished gait speeds in those with abnormal BOX scores were not statistically significant. The authors acknowledged that some of the limitations of the study included study participants being recruited from a regional tertiary care children’s hospital. Therefore, the results of the study cannot be generalized to other populations. Additionally, the sample size of individuals with an abnormal BOX score was limited and predominantly female. The authors suggested that future research efforts examine the role of gender differences in eye tracking with a larger abnormal group. Lastly, the researchers did not assess if participants required glasses or corrective devices.  

Temporal (Non-spatial) Tracking Device to Detect Concussion

Bin Zahid and colleagues (2020) assessed an automated eye-tracking algorithm as a biomarker for concussion as defined by its symptoms and the clinical signs of convergence insufficiency and accommodation dysfunction. In this cross-sectional case-control study, a total of 56 concussed pediatric participants and 83 uninjured pediatric controls underwent eye tracking prospectively. Participants were not spatially calibrated to the tracker to allow independent analysis of each pupil position over time. Researchers obtained metrics comparing velocity and conjugacy of eye movements over time and compared them with the correlation between Acute Concussion Evaluation (ACE) scores, accommodation, and convergence. The investigators found that the 12 eye-tracking metrics were significantly different between the concussed and non-concussed cohorts. They observed that a model to classify concussions as diagnosed by symptoms using the ACE had an area-under-the-curve (AUC) of 0.854. The researchers also indicated that an eye-tracking model built to identify near-point-of-convergence (NPC) disability achieved 95.8% specificity and 57.1% sensitivity for an AUC of 0.810. Eye tracking detected convergence and accommodative abnormalities as well as other types of oculomotor dysfunction associated with concussion. The authors noted that individuals without head injury but with body trauma or other orthopedic injuries were not studied; therefore, it is not known if the results of this study can be applied to individuals without a head injury. Also, the model-building data set consisted primarily of teens, whereas the control participants in the cross-validation data set were generally older than 20 years of age. This could have led to a higher false-positive rate and a lower sensitivity in the cross-validation data set. Additional studies are needed to clarify whether patterns of eye-tracking abnormalities demonstrated after concussion are age dependent.

The EyeBOX Device to Diagnose Concussion

In 2018, the United States Food and Drug Administration (FDA) granted De Novo classification to EyeBOX as the first non-invasive, baseline-free tool directed at diagnosing concussions. The FDA approval letter includes the following indications for use:

• The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), within one week of head injury in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion.
• A negative EyeBOX classification may correspond to eye movement that is consistent with a lack of concussion.
• A positive EyeBOX classification corresponds to eye movement that may be present in both patients with or without concussion (FDA, 2021).

During the examination, the EyeBOX displays a 220 second video for the individual to watch. As the individual watches the video, the EyeBOX measures and analyzes eye movements to provide objective data that is used to aid in the diagnosis of concussion. The test generates an aggregate score ranging from 0 to 20 which is referred to as the Box score. A Box score of less than 10 may correspond to eye movement that is consistent with a lack of concussion. A Box score of 10 or greater corresponds to eye movement that may be present in both individuals with or without concussion. Additionally, EyeBOX also generates a report which the physician would use to interpret the validity of the test results.

The EyeBOX test takes approximately 4 minutes to complete and should be performed within 1 week of the head injury. The EyeBOX is not considered a standalone diagnostic test but should be used in conjunction with a neurological assessment and a comprehensive eye exam.

EyeBOX differs from other tests that utilize eye analysis technology to identify individuals that may have sustained a concussion. Other technologies require a baseline test, which is often completed at the beginning of a sport season, pre-injury, and is compared to subsequent test results at the time of a suspected concussion. However, when evaluating trauma subjects in the emergency room, a baseline concussion assessment is often not available. Because the EyeBOX does not require an initial or previous baseline examination results, it differs from the other technologies that utilize eye analysis data to rule out or confirm suspected concussion. The EyeBOX technology captures thousands of data points based on cranial nerve function and subtle eye movements to generate the BOX score which is an indicator of the likelihood of concussion.

In 2015, Samadani and colleagues discussed the challenges in making an accurate diagnosis of concussion or other forms of TBI and highlighted the differences between spatially and non-spatially calibrated eye tracking. Potential applications of the algorithm include improved diagnosis and detection of diseases ranging from internuclear ophthalmoplegia to strabismus, however its greatest initially recognized value is as a potential outcome measure or biomarker for brain injury and concussion. The author stated that the utility of non-spatially calibrated eye tracking will ultimately be determined by researchers and clinicians who will conduct additional clinical trials that demonstrate the value of non-spatially calibrated eye tracking. This article also includes an overview of two other published studies co-authored by this author which are discussed below (Samadani 2015[a]).

Samadani and colleagues (2015c) conducted a study to identify disconjugacy gaze in individuals that had suffered a concussion, regardless of whether the trauma was apparent on brain imaging with CT scan. The researchers prospectively tracked the eye movement of 64 normal, healthy, non-injured control participants and compared the findings to 75 participants with concussion with either a positive head computed tomography (CT) scan (n=13), negative head CT (n=39), or nonhead injury (n=23) to determine whether eye tracking without spatial calibration would identify the disconjugate gaze associated with both structural brain injury and concussion. Tracking metrics were then correlated to a clinical concussion measurement tool (the Sport Concussion Assessment Tool 3 [SCAT3]) in trauma participants. Five out of five measures of horizontal disconjugacy were increased in positive and negative head CT participants relative to the noninjured control participants. Only one of five vertical disconjugacy measures was significantly increased in participants with concussion relative to controls. Balance testing (Balance Error Scoring System) did not reveal any significant differences in the two concussion groups relative to the control group. Linear regression analysis of all 75 trauma participants demonstrated that three metrics for horizontal disconjugacy negatively correlated with SCAT3 symptom severity score and positively correlated with total Standardized Assessment of Concussion score. Only 39 (11 of 23 controls, 22 of 39 negative head CT participants, and 6 of 13 positive head CT participants) of the 75 trauma participants returned at least once for follow-up evaluation. Though there were no differences in symptom severity among the participants who returned for follow-up compared to those who did not in the negative CT or positive CT groups, among the control participants, those with more symptoms on SAC assessment were more likely to complete follow-up (Mann-Whitney U test, p=0.005). Abnormal eye-tracking metrics improved over time toward baseline in concussion group participants observed during follow-up. The authors concluded that the eye tracking device correlates with extent of symptoms assessed with SCAT3, and may quantitate physiological impact of brain injury regardless of whether it is evident on CT scan.

While the authors concluded that eye tracking without spatial calibration may help quantify the severity of ocular motility disruption associated with concussion and structural brain injury, they also acknowledged some study limitations. For example, in the control cohort, the authors relied on self-report for ophthalmic and medical history. Many participants were hospital employees, research volunteers, colleagues, or friends of the investigative team and may not have been completely forthcoming about their past medical history, medications, and drugs used in the day preceding eye-tracking testing. The long-term impact of medications and other substances consumed more than 1 day prior to testing is unknown. Additionally, not all of the study participants in all comparison groups were on the same concomitantly administered medications. As an example, the medication Keppra occurred more commonly in one group than the others and may have contributed to abnormal eye movements in the positive head CT group. However, the negative head CT cohort had similar eye movement abnormalities as the positive head CT cohort and none of these participants had consumed Keppra. The authors also acknowledged that strabismus, some congenital conditions, and some conditions leading to acquired disconjugacy might yield a false positive with the algorithm. Lastly, the authors indicate that because neither formal optometric nor ophthalmic testing was performed in the trauma setting, it could be useful to conduct additional studies that compared eye movement assessments conducted by trained neurological or ophthalmic consultants to those conducted by the eye-tracking device. It is worth noting that a potential conflict of interest may exist in that the principal investigator of several of the studies discussed above (Dr. U. Samadani) disclosed an equity interest in the technology being investigated in this study via ownership of intellectual property assigned to NYU, VA, and HCMC and licensed to Oculogica Inc. Additionally, investigator R. Ritlop, disclosed an equity interest in Oculogica Inc. The remaining authors declared that there was no potential conflict of interest.

In 2022, Samadani and colleagues reported the results of a study that was conducted to obtain data for FDA marketing authorization. The study assessed the sensitivity and specificity of a baseline-free eye movement tracking algorithm that was developed as a classifier for identifying concussion. The prospective, nonrandomized, and uncontrolled study was carried out in an “intended use” population that included 282 participants (177 adults and 105 pediatric individuals), aged 4-67 years and suspected of having a concussion. The participants were recruited from an emergency room or concussion clinic at 6 independent locations. The authors explained that the study design did not include a control group because the intended use of the device was not for individuals who did not have a history of possible brain trauma. Members of the research teams conducting the eye tracking were blinded to the clinical examination findings and the clinical teams were blinded to the research results. Data were collected using the EyeBOX eye tracking device, alteration of consciousness (AOC), and Sports Concussion Assessment Tool (SCAT3) symptom severity score (SSS) and standardized assessment of concussion (SAC) score. The participant’s medical history was also obtained. Alteration of consciousness was defined as documentation in the medical record by the clinicians caring for the patient that the individual had loss of consciousness or was unresponsive or less responsive at any point following the injury. The results of an eye tracking based classifier model were then validated against a prespecified algorithm with a cutoff for nonconcussed compared to concussed. The sensitivity and specificity of eye tracking were computed after plotting of the receiver operating characteristic curve and calculation of the AUC. When concussion is defined using the SCAT3 SSS and SAC scores, the sensitivity and specificity of an eye tracking algorithm was 80.4%. and 60.1%. The AUC was 0.718 and the misclassification rate (n=282) was 31.6 %. The authors offered that this was an acceptable level of performance because “the data was taken from a heterogeneous population, which was compared to an independent reference standard without an uninjured control group to increase its specificity”. The researchers concluded that a prespecified algorithm and cutoff for the diagnosis of nonconcussion compared to concussion has a sensitivity and specificity that can be used as a baseline-free assistance in the diagnosis of concussion. As noted above, principal investigator Samadani disclosed an equity interest in the technology being investigated in this study. The remaining authors declared that the research was conducted in the absence of any financial or commercial relationships that could be construed as a potential conflict of interest.

In 2024, King and colleagues reported the results of a study comparing the ability of three commercially available eye tracking devices (EyeBox, EYE-SYNC, [SyncThink, Inc., San Carlos, CA] and I-PAS^™ [Neuro Kinetics, Pittsburg, PA]) to distinguish TBI from healthy controls. The study compared the usability and performance of the three eye-tracking devices with each other and a clinical reference standard for concussion. Because time since injury may influence device performance, comparisons were made using both acute (within 72 hours of injury) and chronic (ranging from months to years) mild TBI (mTBI) participants. The research included a total of 216 participants ages 18-45 allocated into one of 3 groups: individuals with a recent concussion (n=63), those with chronic mTBI (n=34), and a cohort without a history of concussion (n=119). Participants underwent testing with all three eye-tracking devices in random order to prevent bias caused by fatigue. To maximize outcomes, poorer quality data were removed from analysis using specific criteria where possible. Final analysis included the data of 49 acute mTBI participants, 34 chronic mTBI participants and 49 control participants. AUCs obtained using 80% of total dataset ranged from 0.690 to 0.950 for the acute cohort and from 0.753 to 0.811 for the chronic mTBI group. Validation with the remaining 20% of dataset produced AUCs ranging from 0.600 to 0.750 for the acute mTBI group and 0.490 to 0.571 for the chronic mTBI group. The authors concluded that potential eye-tracking detection of mTBI ranged from acceptable to excellent for the acute mTBI group but was less consistent for the chronic mTBI cohort. The self-imposed targeted performance (AUC of 08.50) appears achievable, but additional device improvements and research are needed. The discriminant analysis models differed for the acute mTBI group when compared with the chronic group which suggests a more rigorous and/or longitudinal study design is needed to evaluate this observation. The authors also point out that mTBI injuries were not controlled for in this study and may have contributed to a reduction in the eye-tracking assessment sensitivity.

Masters and colleagues (2025) conducted a prospective study that aimed to assess how useful objective infrared eye tracking with the EyeBox device is for identifying concussion-related vision disorders (CRVDs) in adolescents who continue to have persisting post-concussive symptoms (PPCS) more than 28 days post injury. Study participants were evaluated with VVE, comprehensive vision examination, and an eye tracking device. A total of 108 participants were enrolled in the study, of which 67 (62%) were diagnosed with a concussion-related vision disorder by a comprehensive vision examination, with the most common diagnosis being convergence insufficiency. The study demonstrated that the average BOX score was significantly higher for participants with concussion-related vision disorders compared with participants who did not have vision disorders (8.1 ± 5.8 vs. 5.2 ± 4.1; p=0.007). The study found that each 1-point increase in the BOX score was linked to a 15% higher chance of having a concussion-related vision disorder. The authors concluded that concussion-related vision disorders reflecting various types of oculomotor dysfunction are common in individuals with PPCS and that using a screening visio-vestibular exam in conjunction with infrared eye tracking can help identify individuals who should be referred sooner to a vision specialist for diagnosis and treatment in the hopes of improving their symptoms. The authors acknowledged that this study had several limitations. The population studies only included adolescents with ongoing post-concussion symptoms, so the results may not apply to younger children, adults, or those seen within the first month after injury. Future research could explore how age and development affect these symptoms, as well as other factors such as medication use. Longer-term studies would also facilitate understanding how these vision problems change over time and affect outcomes. Additionally, children with pre-existing vision problems were excluded, so the findings may not apply to that group. It is also possible that some participants had undiagnosed vision issues prior to their concussion, which could have increased the number of vision disorders found. However, the types and rates of vision problems reported were similar to those seen in earlier studies.

In their discussion of emerging concussion evaluation tools, the American Medical Society for Sports Medicine (AMSSM) Position Statement on Concussion in Sport (Harmon, 2019) states the following:

Other technologies such as app-based measures of reaction time, eye trackers, postural stability, speech pattern, quantitative electroencephalography, and various abbreviated neurocognitive tests are being developed. Some are available on portable electronic platforms with the ability to share information with multiple users. These newer technologies do not have sufficient research to establish their utility.

According to the Centers for Disease Control and Prevention (CDC, 2025a):

A TBI affects how the brain works. A traumatic brain injury, or TBI, is an injury that affects how the brain works. It may be caused by a:

• Bump, blow, or jolt to the head, or
• Penetrating injury (such as from a gunshot) to the head

There are three main types of TBI:

• Mild TBI or concussion
• Moderate TBI
• Severe TBI

In 2021, there were more than 69,000 TBI-related deaths and more than 214,000 TBI-related hospitalizations in the United States. The most common causes of TBI in the United States are fall, fire-arm related injury, motor vehicle crashes and assaults (CDC, 2025a).

While anyone is at risk for having a TBI, some groups are at increased risk of dying from a TBI or living with long-term problems as a result of TBI. For example, older adults (aged 75 years or older) had the highest numbers and rates of TBI-related hospitalizations and deaths. This age group accounts for approximately 32% of TBI-related hospitalizations and 28% of TBI-related deaths. American Indian/Alaska Native children and adults have higher rates of TBI-related hospitalizations and deaths compared to other racial or ethnic groups. Factors that contribute to this disparity include higher rates of motor vehicle accidents, substance use, and suicide, as well as hurdles in accessing appropriate healthcare (CDC, 2025b).

Concussion may affect multiple clinical domains: cognitive, physical, and emotional or behavioral. Whereas headache is the most commonly reported postconcussion symptom, dizziness, balance disturbances, and confusion or disorientation are also frequently reported. Although amnesia and loss of consciousness were once considered the hallmarks of concussion, neither is required for diagnosis (Scorza, 2019).

Because there is no standard definition or single diagnostic test that can be used to diagnose concussion, healthcare practitioners must rely on clinical guidelines, imaging studies, and assessment tools in conjunction with clinical judgment to make a diagnosis of concussion.

Several eye tracking devices, including the EyeBOX, EYE-SYNC and I-Portal^® Portable Assessment System™ Nystagmograph (I-PAS™), have received FDA clearance and are being investigated as tools to assist in the diagnosis of concussion.

Concussion: Injury to the brain resulting from a mild blow to the head, either with or without loss of consciousness. Also referred to as a mild traumatic brain injury (mTBI).

Convergence: The ability to turn the two eyes inward toward each other in order to view a close object.

Convergence insufficiency: A vision disorder where the eyes struggle to work together when focusing on close objects, producing double or blurred vision.

Disconjugate eye movement (gaze). A failure of the eyes to simultaneously turn in the same direction.

Glasgow Coma Scale (GCS): A scoring system to describe the level of consciousness in an individual following a traumatic brain injury. It is used to assist with measuring the severity of an acute brain injury.

Vergence: The simultaneous movement of both eyes in opposite directions to obtain or maintain single binocular vision during focusing.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure code, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Armstrong RA. Visual problems associated with traumatic brain injury. Clin Exp Optom. 2018; 101(6):716-726.
2. Bin Zahid A, Hubbard ME, Lockyer J, et al. Eye tracking as a biomarker for concussion in children. Clin J Sport Med. 2020; 30(5):433-443.
3. Bishay AE, Williams KL, De Oliviera N, et al. Evaluation of sport-related concussion using objective eye tracking. Brain Inj. 2025: 1-7.
4. Cifu DX, Wares JR, Hoke KW. Differential eye movements in mild traumatic brain injury versus normal controls. J Head Trauma Rehabil. 2015; 30(1):21-28.
5. Hawryluk GW, Manley GT. Classification of traumatic brain injury: past, present, and future. Handb Clin Neurol. 2015; 127:15-21.
6. Howell DR, Brilliant AN, Storey EP, et al. Objective eye tracking deficits following concussion for youth seen in a sports medicine setting. J Child Neurol. 2018; 33(12):794-800.
7. King J, Friend C, Zhang D, Carr W. Comparative performance of three eye-tracking devices in detection of mild traumatic brain injury in acute versus chronic subject populations. Mil Med. 2024; 189(Suppl 3):628-635.
8. Maas AI, Menon DK, Steyerberg EW, et al.; CENTER-TBI Participants and Investigators. Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI): a prospective longitudinal observational study. Neurosurgery. 2015; 76(1):67-80.
9. Master CL, Scheiman M, Podolak OE, et al. Metrics of concussion-related vision disorders among children and adolescents with persisting post-concussive symptoms using an objective eye tracking device. J Sport Health Sci. 2025; 14:101058.
10. Oldham JR, Meehan WP 3rd, Howell DR. Impaired eye tracking is associated with symptom severity but not dynamic postural control in adolescents following concussion. J Sport Health Sci. 2021; 10(2):138-144.
11. Samadani U. A new tool for monitoring brain function: eye tracking goes beyond assessing attention to measuring central nervous system physiology. Neural Regen Res. 2015(a); 10(8):1231-1233.
12. Samadani U, Farooq S, Ritlop R, et al. Detection of third and sixth cranial nerve palsies with a novel method for eye tracking while watching a short film clip. J Neurosurg. 2015(b); 122(3):707-720.
13. Samadani U, Ritlop R, Reyes M, et al. Eye tracking detects disconjugate eye movements associated with structural traumatic brain injury and concussion. J Neurotrauma. 2015(c); 32(8):548-56.
14. Samadani U, Spinner RJ, Dynkowski G, et al. Eye tracking for classification of concussion in adults and pediatrics. Front Neurol. 2022; 13:1039955.
15. Stuart S, Parrington L, Martini D, et al. The measurement of eye movements in mild traumatic brain injury: a structured review of an emerging area. Front Sports Act Living. 2020; 2:5.
16. Thiagarajan P, Ciuffreda KJ, Ludlam DP. Vergence dysfunction in mild traumatic brain injury (mTBI): a review. Ophthalmic Physiol Opt. 2011; 31(5):456-468.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Centers for Disease Control and Prevention. Traumatic brain injury and concussion. Facts about TBI. April 4, 2025a. Available at: https://www.cdc.gov/traumatic-brain-injury/data-research/facts-stats/index.html#:~:text=Severe%20TBI-,TBI%20is%20a%20major%20cause%20of%20death%20and%20disability,be%20affected%20by%20TBI%2C%20include. Accessed on March 26, 2026.
2. Centers for Disease Control and Prevention. Traumatic brain injury and concussion. Health Disparities in TBI. January 30, 2025b. Available at: https://www.cdc.gov/traumatic-brain-injury/health-equity/index.html. Accessed on March 26, 2026.
3. Harmon KG, Clugston JR, Dec K, et al. American Medical Society for Sports Medicine position statement on concussion in sport. Br J Sports Med. 2019; 53(4):213-225.
4. Scorza KA, Cole W. Current concepts in concussion: initial evaluation and management. Am Fam Physician. 2019; 99(7):426-434.
5. U. S. Food and Drug Administration (FDA) Decision summary for EyeBOX (DEN170091). Brain Injury adjunctive interpretive occulomotor assessment aid. Rockville, MD: FDA. December 28, 2018. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/DEN170091.pdf. Accessed on March 26, 2026.
6. U. S. Food and Drug Administration (FDA) Premarket Notification for EyeBOX (Model EBX-4). Traumatic brain injury eye movement assessment aid. Rockville, MD: FDA. Last reviewed: April 20, 2023. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212310.pdf. Accessed on March 26, 2026.
7. U. S. Food and Drug Administration (FDA) Decision summary for EYE-SYNC (K202927). Brain injury adjunctive interpretive oculomotor assessment aid. Rockville, MD: FDA. October 21, 2021. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf20/K202927.pdf. Accessed on March 26, 2026.
8. U. S. Food and Drug Administration (FDA) Decision summary for I-PAS (K171884). I-Portal^® Portable Assessment System^™ - Nystagmograph (I-PAS). Rockville, MD: FDA. November 22, 2018. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171884.pdf. Accessed on March 26, 2026.

1. National Institute of Neurological Disorders and Stroke. Traumatic brain injury (TBI, 2026). Available at: https://www.ninds.nih.gov/health-information/disorders/traumatic-brain-injury-tbi. Accessed on March 26, 2026.  

Concussion
EYE-SYNC
EyeBOX,
Eye movement analysis
Eye tracking analysis using non-spatial calibration
I-Portal^® Portable Assessment System™ Nystagmograph (I-PAS)
Mild traumatic brain injury (mTBI)

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