Status:
ACTIVE_NOT_RECRUITING
Persistent Post-Concussion Symptoms With Convergence Insufficiency
Lead Sponsor:
New Jersey Institute of Technology
Collaborating Sponsors:
Salus University
Children's Hospital of Philadelphia
Conditions:
Persistent Post-concussive Symptoms
Convergence Insufficiency
Eligibility:
All Genders
11-35 years
Phase:
NA
Brief Summary
Our successful R01 discovered 1) the neural mechanistic difference between typically occurring convergence insufficiency (TYP-CI) and binocularly normal controls and 2) the underlying mechanism of off...
Detailed Description
During the past 6 years, our study team investigated the neural mechanism of typically-occurring convergence insufficiency (TYP-CI), the most common binocular vision disorder in children and young adu...
Eligibility Criteria
Inclusion
- Between 11 to 35 years
- Concussion diagnosed by a clinical 1 to 6 months ago
- Best-corrected visual acuity of 20/25 in both eyes at distance and near
- willing to wear glasses or contact to correct refractive error if needed
- Global stereopsis of 500 sec of arc or better and 70 sec of arc of better using Randot Stereo Test
- Diagnosis of convergence insufficiency from an optometrist defined as near point of convergence of greater than or equal to 6 cm, positive fusional vergence at 40 cm not meeting Sheard's criteria of at least twice the near phoria or a range of less than or equal to 15 prism diopters, and a convergence insufficiency symptom survey score of 21 or greater for adults or 16 or greater for children.
Exclusion
- History of performing office or home-based vision therapy, orthoptics, home-based near target push-ups, or pencil push ups
- Amblyopia (lazy eye) or constant strabismus or strabismus surgery
- Any conditions or diseases that affect accommodation, vergence or ocular motility, such as Multiple Sclerosis, Graves' thyroid disease, Myastheria Gravis, Diabetes, Chemotherapy, or Parkinson's Disease
- Non-removable metal in the body
- Pregnant, planning on becoming pregnant during the study duration, or breastfeeding
- Metal worker
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 28 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05262361
Start Date
September 1 2021
End Date
August 28 2026
Last Update
May 13 2025
Active Locations (2)
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1
NJIT
Newark, New Jersey, United States, 07102
2
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104