Natural History of MTBI-related Convergence Insufficiency & Effectiveness of Vision Therapy for MTBI-related CI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Office-Based Vergence/Accommodative Therapy with Movement (OBVAM).
- Who it may be relevant to
- Registry conditions: Convergence Insufficiency. Basic parameters: 18 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Other 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
Primary outcome measures
- Clinical Composite Measure [Time frame: 6 weeks]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- • 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)
- 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
Exclusion criteria
- • 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06848673 · VR230111 · VR230111