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

NCT06848673 | Not Yet Recruiting Phase 2

• 1 other identifier: VR230111
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Convergence Insufficiency

Keywords

Convergence Insufficiency; Vision Therapy; mTBI; Concussion; Office-based vergence/accommodative therapy

Outcome Measures

Primary Outcomes (1)

• 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

  6 weeks

Secondary Outcomes (2)

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

  6 weeks

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

  6 weeks

Study Arms (2)

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

EXPERIMENTAL

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.

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

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

ACTIVE COMPARATOR

Same as immediate group but delayed 6 weeks

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

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Salus University: lead

MeSH Terms

Conditions

Ocular Motility Disorders; Brain Concussion

Interventions

Movement

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mitchell Scheiman, OD, PhD

  Drexel University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MItchell Scheiman, OD, PhD

CONTACT

215-780-1427; ms5758@drexel.edu

Susan Cotter, OD, MS

CONTACT

215-780-1427; scotter@ketchum.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The examiner who performs the sensory-motor vision examination will be masked to the assigned treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization to immediate OBVAM or delayed OBVAM

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 27, 2025
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share