Vision Therapy for Post-Concussion Syndrome

(PPCS-CI Trial)

Not currently recruiting at 2 trial locations

Overseen By Tara L Alvarez, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: New Jersey Institute of Technology

Disqualifiers: Amblyopia, Strabismus, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 19

Duration: 6-14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a vision therapy for individuals with post-concussion syndrome who struggle with eye convergence (the ability of both eyes to work together). The therapy, known as office-based vergence and accommodative therapy, is compared with standard concussion care to determine which is more effective. Participants will either begin therapy immediately or experience a short delay to observe if symptoms improve naturally. The trial seeks individuals aged 11 to 35 who experienced a concussion in the last 1 to 6 months and have been diagnosed with convergence insufficiency by an optometrist. As an unphased trial, this study provides a unique opportunity to enhance understanding and treatment of post-concussion vision issues.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have conditions like Multiple Sclerosis, Graves' thyroid disease, Myasthenia Gravis, Diabetes, or Parkinson's Disease, you may not be eligible to participate.

What prior data suggests that this vision therapy is safe for post-concussion syndrome?

Research has shown that office-based Vergence and Accommodative Therapy is safe for treating vision problems after a concussion. One study found that nearly 90% of teenagers and young adults with post-concussion vision issues improved after 12 weeks of therapy. Another report indicated that this therapy helps people recover faster than waiting for symptoms to improve on their own. These findings suggest that the therapy is generally well-tolerated and usually does not cause harmful side effects. Positive results from previous studies offer reassurance about the safety of this treatment for improving vision problems after concussions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about office-based Vergence and Accommodative Therapy for post-concussion syndrome because it offers a targeted approach to address visual symptoms often overlooked by standard treatments like rest and medication. Unlike typical care that focuses on general symptom management, this therapy specifically strengthens eye coordination and focusing abilities, which can be directly impacted by concussions. Moreover, it incorporates objective assessments like functional MRI scans and eye movement recordings to track progress, providing a more precise evaluation of its effectiveness. This specialized focus has the potential to enhance recovery outcomes for individuals struggling with persistent visual disturbances after a concussion.

What evidence suggests that Office-based Vergence and Accommodative Therapy is effective for post-concussion syndrome?

Research has shown that office-based vergence and accommodative therapy (OBVAT) effectively treats convergence insufficiency, particularly after a concussion. One study found that patients experienced improvement in eye coordination symptoms after 16 therapy sessions. In this trial, one group will receive OBVAT immediately after enrollment, while another group will start therapy after a 6-week delay to evaluate natural recovery. Another study indicated that this therapy helps people recover faster from eye issues caused by concussions, offering an alternative to the usual "wait and see" approach. Additionally, brain scans from the CONCUSS clinical trial showed positive changes in the brain from this therapy. Overall, this treatment is considered one of the best options for easing symptoms related to post-concussion convergence insufficiency. ^{1 3 6 7 8}

Who Is on the Research Team?

Tara Alvarez, PhD

Principal Investigator

New Jersey Institute of Technology

Are You a Good Fit for This Trial?

This trial is for young people aged 13-25 who've had a concussion diagnosed by a professional 1 to 3 months ago and are experiencing eye coordination issues (convergence insufficiency) affecting reading or screen use. They must have certain levels of visual acuity and stereopsis, be willing to wear corrective lenses if needed, and meet specific criteria on an eye symptom survey.

Inclusion Criteria

An eye doctor has diagnosed you with convergence insufficiency, which means your eyes have trouble working together at close distances, and you have specific test results and symptoms.

You have good depth perception, as measured by a specific eye test.

I am willing to wear glasses or contacts if needed.

Exclusion Criteria

I have a lazy eye or have had surgery for crossed eyes.

Pregnant, planning on becoming pregnant during the study duration, or breastfeeding

I work with metals.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment including a masked optometric vision exam, objective eye movement recordings, and a functional MRI scan

1 week

1 visit (in-person)

Treatment

Participants receive office-based vergence and accommodative therapy. One arm starts immediately with 12 sessions over 6 weeks, followed by 4 additional sessions over 2 weeks. Another arm starts after a 6-week delay with 16 sessions over 8 weeks.

6-14 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including outcome assessments by a masked optometrist

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Office-based Vergence and Accommodative Therapy

Trial Overview The study tests office-based therapy aimed at improving the way eyes work together after a concussion. It compares neural mechanisms in typical convergence insufficiency with those post-concussion, assessing how effective either 12 or 16 one-hour therapy sessions are compared to standard care.

How Is the Trial Designed?

Group I: Office based Vergence and Accommodative Therapy immediately after enrollement Experimental Treatment 1 Intervention

This arm will start immediately after baseline assessment. The participant will have two sessions of one hour each for 6 weeks (12 office-based vergence and accommodative therapy sessions). The first outcome measurement will be attained by a masked optometrist. Then, the participant will have 2 more weeks of therapy (4 office-based vergence and accommodative therapy sessions). The second and final outcome measurement will be attained. Assessments include a masked optometric vision exam, objective eye movement recordings and an functional MRI scan.

Group II: Office based Vergence and Accommodative Therapy Delay 6 weeks post enrollment Active Control 1 Intervention

This arm will start with a 6 week delay (no vision therapy) after baseline assessment to evaluate natural recovery. After 6 weeks, the first outcome assessment will be attained by a masked optometrist. The participant will have two sessions of one hour each for 8 weeks (16 office-based vergence and accommodative therapy sessions). The second and final outcome measurement will be attained. Assessments include a masked optometric vision exam, objective eye movement recordings and an functional MRI scan.

Office-based Vergence and Accommodative Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Office-based Vergence/Accommodative Therapy for:

• Convergence Insufficiency
• Persistent Post-Concussion Symptoms

Approved in European Union as Office-based Vergence/Accommodative Therapy for:

• Convergence Insufficiency

Who Is Running the Clinical Trial?

New Jersey Institute of Technology

Lead Sponsor

Trials

11

Recruited

1,100+

Salus University

Collaborator

Trials

16

Recruited

1,100+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

Somerset Pediatric Group

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

This study evaluated the effects of office-based vision therapy (OBVT) on five individuals with concussion-related convergence insufficiency (CI) and found significant improvements in objective measures of disparity vergence, including peak velocity and accuracy, indicating that OBVT can effectively enhance eye coordination after a concussion.

The research suggests that objective measures of disparity vergence can provide valuable insights into the physiological changes associated with CI, making them suitable for use in larger clinical trials to assess treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objective Assessment of Vergence after Treatment of Concussion-Related CI: A Pilot Study. Scheiman, MM., Talasan, H., Mitchell, GL., et al.[2018]

Vision disturbances after traumatic brain injury (TBI) can be effectively addressed through noninvasive rehabilitative interventions like vision therapy, which is provided by optometrists.

Rehabilitative optometric interventions, including the use of specialized spectacles and vision therapy, are beneficial for many TBI patients and should be considered as treatment options to improve their visual function and overall recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision Disturbances Following Traumatic Brain Injury. Kapoor, N., Ciuffreda, KJ.[2020]

Individuals with mild traumatic brain injury (mTBI) show abnormal vergence and accommodation responses, including slowed and inaccurate dynamics compared to healthy controls, indicating significant visual processing issues.

Short-term oculomotor-based vision therapy can partially remediate these abnormalities, suggesting that the brain retains a degree of neuroplasticity even after injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objectively-based vergence and accommodative dynamics in mild traumatic brain injury (mTBI): A mini review. Ciuffreda, KJ., Thiagarajan, P.[2022]

In a study of 19 adults with binocular vision disorders following brain injury, 12 weeks of home-based computer vergence therapy led to significant improvements in various measures of eye function, including near point of convergence and vergence facility.

Approximately 69% of participants showed successful improvement in near point of convergence, and 92% improved in vergence facility, indicating that this therapy can effectively enhance binocular vision and reduce symptoms associated with convergence insufficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision Therapy for Binocular Dysfunction Post Brain Injury. Conrad, JS., Mitchell, GL., Kulp, MT.[2018]

In a study of 113 adolescents aged 11 to 17, 70% were found to have at least one vision-related diagnosis after a concussion, with the most common issues being vergence disorders (60%) and accommodative disorders (57%).

Current physician-administered screening methods for detecting these vision problems are not very effective, with sensitivities as low as 63% for convergence insufficiency, indicating that comprehensive oculomotor evaluations are necessary for adolescents with persistent post-concussion symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency of oculomotor disorders in adolescents 11 to 17 years of age with concussion, 4 to 12 weeks post injury. Scheiman, M., Grady, MF., Jenewein, E., et al.[2022]

Optometric visual rehabilitation therapy is commonly used for various visual disorders, particularly in patients with conditions like posttrauma visual syndrome and visual midline shift syndrome, often following strokes or head injuries.

However, the scientific evidence supporting these therapies is limited, primarily consisting of case reports and series without control groups, indicating a need for more rigorous studies to validate their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consensus Statement on Visual Rehabilitation in Mild Traumatic Brain Injury. Subramanian, PS., Barton, JJS., Ranalli, P., et al.[2022]

Office-Based Vergence/Accommodative Therapy (OBVAT) effectively treats convergence insufficiency (CI), improving symptoms in about 75% of patients, as shown in a study with 25 symptomatic CI patients who underwent 12 hours of therapy.

Post-therapy assessments revealed significant improvements in near point of convergence, positive fusional vergence, and reduced symptoms, alongside increased functional brain activity in areas related to eye movement control, indicating that OBVAT not only enhances visual function but also engages neural mechanisms involved in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Functional Imaging Changes Induced from Vision Therapy in Patients with Convergence Insufficiency. Alvarez, TL., Scheiman, M., Santos, EM., et al.[2020]

In a study of 40 patients (33 with mild traumatic brain injury and 7 with cerebrovascular accident) who underwent optometric vision therapy, 90% of TBI patients and 100% of CVA patients showed significant improvement in oculomotor dysfunctions, indicating high efficacy of the therapy.

The improvements in symptoms and clinical signs were stable at a follow-up 2 to 3 months later, suggesting that optometric vision therapy can lead to lasting benefits and highlights the brain's ability to adapt and recover despite injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision therapy for oculomotor dysfunctions in acquired brain injury: a retrospective analysis. Ciuffreda, KJ., Rutner, D., Kapoor, N., et al.[2022]

Citations

1. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2025.1703781/full

CONCUSS clinical trial fMRI results Introduction: The CONCUSS clinical trial examined the neural changes associated with office-based vergence/accommodative therapy with movement ( ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11567536/

Effectiveness of treatment for concussion-related convergence ... Previous research showed that office-based vergence and accommodative therapy are the most effective treatments for remediating symptoms and ...

3. bjsm.bmj.com bjsm.bmj.com/content/early/2025/09/30/bjsports-2025-109807

CONCUSS randomised clinical trial of vergence/ ... ... office-based vergence and accommodative therapy had positive results after 16 sessions.21 The additional four sessions led to the following ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41033748/

CONCUSS randomised clinical trial of vergence/ ... Objective: The CONCUSS randomised clinical trial compared the effectiveness of immediate office-based vergence/accommodative therapy with ...

5. aoa.org aoa.org/news/clinical-eye-care/diseases-and-conditions/vision-therapy-yields-faster-recovery-from-concussion-related-eye-condition

Vision therapy yields faster recovery from concussion ... Study overturns “wait and see” approach, showing office-based treatment improves convergence insufficiency outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5182092/

Objective Assessment of Vergence after Treatment of ... This is the first report of the use of objective measures of disparity vergence as outcome measures for concussion-related convergence insufficiency.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03908112

Interventions for Convergence Insufficiency in Concussed ... Primary Objective: To compare the effectiveness of SC, SC+, SC plus office-based vergence/accommodative therapy for improving a composite outcome measure of ...

8. neurosciencenews.com neurosciencenews.com/vision-therapy-concussion-29759/

Vision Therapy Restores Sight in Post-Concussion Eye ... A new study shows that 12 weeks of targeted vision therapy restored normal vision in almost 90% of adolescents and young adults, compared to ...