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NCT Number: NCT06848673

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

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.

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Key information

Conditions

Convergence Insufficiency Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cranial Nerve Diseases Craniocerebral Trauma Eye Diseases Head Injuries, Closed Nervous System Diseases Ocular Motility Disorders Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Clinical Composite Measure

    Time frame: 6 weeks

    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

Secondary outcomes

  1. Comparison of the Change in the Near Point of Convergence (NPC) break and recovery value

    Time frame: 6 weeks

    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).

  2. Comparison of the Change in Positive Fusional Vergence after 6 weeks between the Two Groups

    Time frame: 6 weeks

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

MItchell Scheiman, OD, PhD

CONTACT

[email protected]

215-780-1427

Susan Cotter, OD, MS

CONTACT

[email protected]

215-780-1427

Sponsors and collaborators

Lead sponsor

Salus University

Other

Registry information

Official study 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

Acronym: TBEye

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 27, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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