Clinical trial NCT06848673: Natural History of MTBI-related Convergence Insufficiency & Effectiveness of Vision Therapy for MTBI-related CI
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Convergence Insufficiency
Keywords: Convergence Insufficiency
Vision Therapy
mTBI
Concussion
Office-based vergence/accommodative therapy
Lead sponsor: Salus University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to immediate OBVAM or delayed OBVAM
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Clinical Composite Measure
timeFrame: 6 weeks
Secondary outcomes:
measure: Comparison of the Change in the Near Point of Convergence (NPC) break and recovery value
timeFrame: 6 weeks
measure: Comparison of the Change in Positive Fusional Vergence after 6 weeks between the Two Groups
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Drexel University
name: Mitchell Scheiman, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References: