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.
• 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
• 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
Parallel
Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)
Other interventionHead 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.
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
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).
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).
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