Last updated: March 8, 2024
Sponsor: New Jersey Institute of Technology
Overall Status: Active - Recruiting
Phase
N/A
Condition
Brain Injury
Neurologic Disorders
Treatment
Office-based Vergence and Accommodative Therapy
Clinical Study ID
NCT05262361
2R01EY023261
2R01EY023261
Ages 11-35 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 RandotStereo Test
- Diagnosis of convergence insufficiency from an optometrist defined as near point ofconvergence of greater than or equal to 6 cm, positive fusional vergence at 40 cm notmeeting Sheard's criteria of at least twice the near phoria or a range of less than orequal to 15 prism diopters, and a convergence insufficiency symptom survey score of 21or greater for adults or 16 or greater for children.
Exclusion
Exclusion Criteria:
- History of performing office or home-based vision therapy, orthoptics, home-based neartarget 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
Study Design
Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Office-based Vergence and Accommodative Therapy
Phase:
Study Start date:
September 01, 2021
Estimated Completion Date:
August 28, 2026
Study Description
Connect with a study center
NJIT
Newark, New Jersey 07102
United StatesActive - Recruiting
Somerset Pediatric Group
Raritan, New Jersey 08869
United StatesSite Not Available
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
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