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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Page 1 of 1 (2 locations)

1

NJIT

Newark, New Jersey, United States, 07102

2

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104