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

Launched by SALUS UNIVERSITY · Feb 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a condition called convergence insufficiency (CI), which can affect how well a person’s eyes work together, especially after a mild traumatic brain injury (mTBI) or concussion. The study aims to see if a specific type of vision therapy called office-based vergence/accommodative therapy with movement (OBVAM) can help improve symptoms of CI in people who have experienced an mTBI. Although the trial is not yet recruiting participants, it will involve adults aged 18 to 35 who have been diagnosed with an mTBI or concussion within the last 1 to 6 months and have certain vision problems related to CI.

To be eligible for the trial, participants must have a specific score indicating their symptoms are significant, and they should have good vision with any corrective lenses they might need. Participants will be asked to avoid any other treatments for CI during the study. If you are interested in participating, you will receive therapy aimed at improving your eye coordination, and the study will help researchers understand how effective this therapy is for people with similar conditions.

Gender

ALL

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