Natural History of MTBI-related Convergence Insufficiency & Effectiveness of Vision Therapy for MTBI-related CI (TBEye)

Salus University

Status and phase: Begins enrollment in 8 months; Phase 2

Conditions: Convergence Insufficiency

Treatments: Other: Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06848673

VR230111 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Immediate Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)

Experimental group

Description:

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.

Treatment:

Other: Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)

Delayed Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)

Active Comparator group

Description:

Same as immediate group but delayed 6 weeks

Treatment:

Other: Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)