Convergence InsufficiencyPhase 2TBEyeNCT06848673
Natural History of MTBI-related Convergence Insufficiency & Effectiveness of Vision Therapy for MTBI-related CI
A Phase 2 study testing Office-Based Vergence/Accommodative Therapy with Movement (OBVAM) in people with Convergence Insufficiency, run by Salus University.
Trial summary
The design of this project is a pilot study, a type of feasibility study conducted in preparation for subsequent RCTs that will assess the effectiveness of office-based vergence/accommodative therapy with movement (OBVAM) for mTBI-related convergence insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Convergence Insufficiency
- What is being tested?
- Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Sep 2028
- Phase
- Phase 2
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Age 18 to 35 years inclusive
- Medical diagnosis of mTBI or concussion > 1 month ago and no longer than 6 months ago
- Convergence Insufficiency Symptom (CISS score) ≥ 21
- Best-corrected VA of 20/25 or better in both eyes at distance \& near
- Willingness to wear refractive correction, if indicated
- Random dot stereopsis of 500 arcsec or better (Randot Stereo Test)
Show all 12Show fewer
- Receded NPC of ≥6 cm
- Insufficient PFV (< 15∆ or PFV blur point less than twice the near exophoria magnitude)
- Wearing refractive correction for cycloplegic refractive errors of:
- ≥ +1.25 D SE hyperopia or ≥ -1.00 D SE myopia in either eye
- ≥ 1.25 D astigmatism in either eye, ≥ 1.00 D SE anisometropia
- Astigmatism axis within ±10 degrees if magnitude is ≤1.00 D and within ±5 degrees if >1.00 D
Who cannot join
- • No previous treatment for CI
- No previous diagnosis of CI from an ophthalmologist or optometrist
- No medications known to affect accommodation or vergence
- Investigator \& patient willing to forgo all other CI treatment other than that assigned by randomization
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: PILOT CLINICAL TRIAL (PCT) of the Natural History of the Most Common MTBI-related Oculomotor Disorder Convergence Insufficiency & the Effectiveness of Vergence/Accommodative Therapy for MTBI-related Convergence Insufficiency
The design of this project is a pilot study, a type of feasibility study conducted in preparation for subsequent RCTs that will assess the effectiveness of office-based vergence/accommodative therapy with movement (OBVAM) for mTBI-related convergence insufficiency.
Read the detailed description
The design of this project is a pilot study, a type of feasibility study conducted in preparation for subsequent RCTs that will assess the effectiveness of interventions or therapies. In this application, we refer to this pilot and feasibility study as a pilot clinical trial (PCT). This feasibility PCT aims to identify potential challenges, logistical issues, and unforeseen complications. To do this, we will examine various feasibility aspects, including recruitment and retention, randomization, intervention protocols, outcome measures, ethical considerations, safety monitoring, resource availability, and stakeholder feedback. By conducting this PCT, we can test our procedures and gather preliminary data. The primary objectives of this feasibility PCT are to 1) Determine the feasibility of conducting future full-scale RCTs by evaluating the effectiveness of a novel vergence/accommodative/move (OBVAM) therapy program for young adults with mTBI-CI and 2) Better understand the progression and stability (i.e., natural history) of mTBI-CI over the 6 weeks following enrollment.
- Conditions
- Convergence Insufficiency
- Being tested
- Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)
- Keywords
- Convergence Insufficiency, Vision Therapy, mTBI, Concussion, Office-based vergence/accommodative therapy
- Medical subject headings
- Ocular Motility Disorders, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)Other
Head and body movements are incorporated into some therapy procedures in Phases 3 and 4. Additional details are provided in the Overall Program Narrative. Participants undergoing office-based VAM therapy will be prescribed home therapy procedures including the HTS2 Home Vision Therapy System (https://htsvision.com/) thrice weekly to support their in-office VAM therapy. This software progressively increases fusional convergence and divergence demands, offers instant user feedback, and will allow us to track participants' usage and progress. Basic procedures like free-space fusion cards and Brock String will also be prescribed for home therapy.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Office-Based Vergence/Accommodative Therapy with Movement (OBVAM) | Experimental | 16 sessions, twice per week of office-based vergence/accommodation therapy (OBVASM)While OBVAM therapy retains the essential elements of OBVAT. The OBVAM therapy protocol has four phases. Phase 1 targets visual/vestibular issues typical in mTBI-CI by integrating version eye movements, such as saccades and pursuits, with head and body movements. It also includes gross convergence, monocular accommodative (focusing) flexibility, and simple convergence procedures. The subsequent phases concentrate on enhancing ramp vergence amplitudes and improving accommodative facility (Phase 2), focusing on vergence facility and endurance (Phase 3), and integrating vergence and accommodation (Phase 4). Head and body movements are incorporated into some therapy procedures in Phases 3 and 4. Receives: Other: Office-Based Vergence/Accommodative Therapy with Movement (OBVAM) |
| Delayed Office-Based Vergence/Accommodative Therapy with Movement (OBVAM) | Active comparator | Same as immediate group but delayed 6 weeks Receives: Other: Office-Based Vergence/Accommodative Therapy with Movement (OBVAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Composite Measure
The primary outcome measure is a composite score of two key clinical measures: the near point of convergence (NPC) and positive fusional vergence at near (PFV). At the two outcome visits, each participant's performance on these clinical measures will be categorized according to the following predefined success criteria: 1) Successful: meets both criteria; a) NPC is <6 cm and improved ≥4 cm and b) PFV meets Sheard's criterion and the blur (break, if no blur) is >15Δ and increased ≥10Δ; 2) Improved: NPC improved ≥4 cm and PFV improved ≥10Δ; and 3) Non-Responder: Does not meet criteria for successful or improved
Measured: 6 weeks
Secondary outcomes (2)
Comparison of the Change in the Near Point of Convergence (NPC) break and recovery value
A standard near point rod will be used to measure the ability to converge the eyes. We will measure the NPC break (when double vision occurs) and the NPC recovery (when single vision is restored) . A comparison of the change in the break and recovery between the immediate and the delayed groups will be analyzed from baseline to to the first outcome visit (after 6 weeks).
Measured: 6 weeks
Comparison of the Change in Positive Fusional Vergence after 6 weeks between the Two Groups
A hand-held prism bar will be used to assess positive fusional vergence (PFV) at baseline and after 6 weeks. We will measure the PFV break (when double vision occurs) and the PFV recovery (when single vision is restored) . A comparison of the change in the break and recovery between the immediate and the delayed groups will be analyzed from baseline to to the first outcome visit (after 6 weeks).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Nov 2026 (estimated)
- Primary completion30 Apr 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to immediate OBVAM or delayed OBVAM
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell Scheiman, OD, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848673
- Sponsor's protocol ID
- VR230111
- Other IDs
- VR230111
- Acronym
- TBEye
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 27 Feb 2025
- 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PILOT CLINICAL TRIAL (PCT) of the Natural History of the Most Common MTBI-related Oculomotor Disorder Convergence Insufficiency & the Effectiveness of Vergence/Accommodative Therapy for MTBI-related Convergence Insufficiency
- ClinicalTrials.gov ID
- NCT06848673
- Acronym / sponsor ID
- TBEye / VR230111
- Conditions
- Convergence Insufficiency
- Keywords
- Convergence Insufficiency, Vision Therapy, mTBI, Concussion, Office-based vergence/accommodative therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Salus UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 27 Feb 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.
The design of this project is a pilot study, a type of feasibility study conducted in preparation for subsequent RCTs that will assess the effectiveness of office-based vergence/accommodative therapy with movement (OBVAM) for mTBI-related convergence insufficiency.
Detailed description
The design of this project is a pilot study, a type of feasibility study conducted in preparation for subsequent RCTs that will assess the effectiveness of interventions or therapies. In this application, we refer to this pilot and feasibility study as a pilot clinical trial (PCT). This feasibility PCT aims to identify potential challenges, logistical issues, and unforeseen complications. To do this, we will examine various feasibility aspects, including recruitment and retention, randomization, intervention protocols, outcome measures, ethical considerations, safety monitoring, resource availability, and stakeholder feedback. By conducting this PCT, we can test our procedures and gather preliminary data. The primary objectives of this feasibility PCT are to 1) Determine the feasibility of conducting future full-scale RCTs by evaluating the effectiveness of a novel vergence/accommodative/move (OBVAM) therapy program for young adults with mTBI-CI and 2) Better understand the progression and stability (i.e., natural history) of mTBI-CI over the 6 weeks following enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomization to immediate OBVAM or delayed OBVAM
| Arm | Type | Receives |
|---|---|---|
| Immediate Office-Based Vergence/Accommodative Therapy with Movement (OBVAM) | Experimental | Other: Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)16 sessions, twice per week of office-based vergence/accommodation therapy (OBVASM)While OBVAM therapy retains the essential elements of OBVAT. The OBVAM therapy protocol has four phases. Phase 1 targets visual/vestibular issues typical in mTBI-CI by integrating version eye movements, such as saccades and pursuits, with head and body movements. It also includes gross convergence, monocular accommodative (focusing) flexibility, and simple convergence procedures. The subsequent phases concentrate on enhancing ramp vergence amplitudes and improving accommodative facility (Phase 2), focusing on vergence facility and endurance (Phase 3), and integrating vergence and accommodation (Phase 4). Head and body movements are incorporated into some therapy procedures in Phases 3 and 4. |
| Delayed Office-Based Vergence/Accommodative Therapy with Movement (OBVAM) | Active comparator | Other: Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)Same as immediate group but delayed 6 weeks |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- • Age 18 to 35 years inclusive
Key exclusion criteria (4 listed)
- • No previous treatment for CI
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 |
|---|---|---|
| Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)Head and body movements are incorporated into some therapy procedures in Phases 3 and 4. Additional details are provided in the Overall Program Narrative. Participants undergoing office-based VAM therapy will be prescribed home therapy procedures including the HTS2 Home Vision Therapy System (https://htsvision.com/) thrice weekly to support their in-office VAM therapy. This software progressively increases fusional convergence and divergence demands, offers instant user feedback, and will allow us to track participants' usage and progress. Basic procedures like free-space fusion cards and Brock String will also be prescribed for home therapy. | Other | Delayed Office-Based Vergence/Accommodative Therapy with Movement (OBVAM), Immediate Office-Based Vergence/Accommodative Therapy with Movement (OBVAM) |
Primary outcome
Clinical Composite Measure
Time frame: 6 weeks
The primary outcome measure is a composite score of two key clinical measures: the near point of convergence (NPC) and positive fusional vergence at near (PFV). At the two outcome visits, each participant's performance on these clinical measures will be categorized according to the following predefined success criteria: 1) Successful: meets both criteria; a) NPC is <6 cm and improved ≥4 cm and b) PFV meets Sheard's criterion and the blur (break, if no blur) is >15Δ and increased ≥10Δ; 2) Improved: NPC improved ≥4 cm and PFV improved ≥10Δ; and 3) Non-Responder: Does not meet criteria for successful or improved
2 secondary outcomes
Comparison of the Change in the Near Point of Convergence (NPC) break and recovery value
Time frame: 6 weeks
Comparison of the Change in Positive Fusional Vergence after 6 weeks between the Two Groups
Time frame: 6 weeks
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 27 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Mitchell Scheiman, OD, PhD principal investigator
Drexel University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Office-Based Vergence/Accommodative Therapy with Movement (OBVAM) in people with Convergence Insufficiency, run by Salus University.
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 12 inclusion and 4 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: opening soon, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 MItchell Scheiman, OD, PhD (215-780-1427, ms5758@drexel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Composite Measure (time frame: 6 weeks). 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 27 Feb 2025.