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| ID | Type | Description | Link |
|---|---|---|---|
| VR230111 | Other Grant/Funding Number | Department of Defense |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Delayed Office-Based Vergence/Accommodative Therapy with Movement (OBVAM) | Active Comparator | Same as immediate group but delayed 6 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
• Age 18 to 35 years inclusive
Exclusion Criteria:
• No previous treatment for CI
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MItchell Scheiman, OD, PhD | Contact | 215-780-1427 | ms5758@drexel.edu | |
| Susan Cotter, OD, MS | Contact | 215-780-1427 | scotter@ketchum.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mitchell Scheiman, OD, PhD | Drexel University | Principal Investigator |
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| ID | Term |
|---|---|
| D015835 | Ocular Motility Disorders |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D009068 | Movement |
| ID | Term |
|---|---|
| D010829 | Physiological Phenomena |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Randomization to immediate OBVAM or delayed OBVAM
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The examiner who performs the sensory-motor vision examination will be masked to the assigned treatment group
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| 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). | 6 weeks |
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |