Natural History of MTBI-related Convergence Insufficiency & Effectiveness of Vision Therapy for M… (NCT06848673) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Natural History of MTBI-related Convergence Insufficiency & Effectiveness of Vision Therapy for MTBI-related CI
100 participantsStarted 2026-11-01
Plain-language 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.
Who can participate
Age range18 Years – 35 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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