Clinical Trials


Interventions for Convergence Insufficiency in Concussed Children (ICONICC)

Intervention Type: Behavioral
Study Type: Interventional
Sponsors: Stanford University, Boston Children's Hospital, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, New Jersey Institute of Technology, Marshall B. Ketchum University, University of Alabama at Birmingham, Ohio State University, Mitchell Scheiman
Participants: 264
Chris Kotures, Tawna Roberts, Gerald Grant, Katherine Weise, Gladys Lynn Mitchell, Heath Hale, Angela Chen, Lisa Jones-Jordan, Tara Alvarez
The ICONICC Study is a randomized controlled clinical trial designed to compare the proportion of successful treatment outcomes between children assigned to standard concussion care only, standard concussion care plus simple convergence procedures, or standard concussion care plus office-based vergence/accommodative therapy in children aged 11 to 17 years with symptomatic post-concussion syndrome. Children with post-concussion syndrome (4-12 weeks post-concussion injury) and symptomatic CI will be randomized to a 12-week treatment program of either standard concussion care (SC), SC plus simple convergence procedures (SC+), or SC plus office-based vergence/accommodative therapy SC+OBVAT (1:1:1 ratio). The study will also compare the effect of treatment on clinical measures of both accommodation and vergence, symptom level/burden, health-related quality of life, clinical measures of saccadic eye movement, and objective eye movement measurements of disparity vergence, saccadic function, and accommodative function. The attainment of objective eye movement measures provides an opportunity to understand the underlying neurophysiology of the vergence and accommodative systems. Objective eye movement recordings are powerful because of the rich foundation from primate single-cell recordings that show a direct correlation with vergence and accommodative parameters in the supraoculomotor area of midbrain2, 3 and the oculomotor vermis of the cerebellum.4, 5 Thus, a combined approach of acquiring both clinical vision function measures and objective eye movement recordings in children with PCS-CI may lead to better characterization of the oculomotor phenotype with subsequent improved and personalized therapeutic interventions.
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Stanford University Medical Center
Palo Alto, United States of America
New Jersey Institute of Technology
Newark, United States of America
Boston's Children's Hospital
Boston, United States of America
Cincinnati Children's Hospital Medical Center
Cincinnati, United States of America
University of Alabama Birmingham
Birmingham, United States of America
The Ohio State University College of Optometry
Columbus, United States of America
Salus University/Children's Hospital of Philadelphia
Philadelphia, United States of America
Marshall B. Ketchum University, Southern CA College of Optomwtry
Fullerton, United States of America
Wendy Woodward
Mitchell Scheiman, OD, PhD
Sex: All
Minimum Age: 11
Maximum Age: 17
Healthy Volunteers: Accepts Healthy Volunteers
Inclusion Criteria:
ICONICC will enroll children of all races and will adhere to a policy of equitability. To be eligible to participate in ICONICC, the child must meet all of the following criteria:
- Medical diagnosis of concussion of at least 4 weeks and no longer than 12 weeks since known date of injury
- Age 11 to 17 years
- Gender - any
- CI Symptom Survey (CISS) score ≥ 16
- Exophoria at near at least 4∆ greater than at far
- Receded near point of convergence (NPC) of greater than 6 cm break
- Insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard's criterion1 or PFV ≤15∆ base-out break)
- Best-corrected distance visual acuity of 20/25 or better in each eye
- Random dot stereopsis appreciation of 500 seconds of arc or better using the Randot Stereotest
- Willing to wear refractive correction for any of the following uncorrected refractive errors based on a cycloplegic refraction performed at the eligibility examination. (Correction must be worn for at least 2 weeks):
- Myopia > -0.75 D spherical equivalent in either eye
- Hyperopia > 2.00 D spherical equivalent in either eye
- Anisometropia > 0.75D spherical equivalent or ≥ 1.50 D in any meridian
- Astigmatism > 1.00 D in either eye
- Willing to discontinue BI prism or a plus add at near for duration of study (must discontinue at least 2 weeks before eligibility examination)
- Parent and child understand protocol and are willing to accept randomization
- Normal pupillary responses
Exclusion Criteria:
- Any strabismus at distance
- Constant strabismus at near
- Limitation on versions/ductions due to restrictive or paretic strabismus
- Esophoria of ≥ 2∆ at distance
- Vertical heterophoria ≥ 2∆ at distance or near
- ≥ 2 line interocular difference in best-corrected visual acuity
- Manifest or latent nystagmus
- History of surgery or botulinum toxin for strabismus or any type of refractive surgery
- Previous diagnosis of CI by an eye care professional before concussion
- Diseases known to affect accommodation, vergence, or ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, Parkinson's disease
- Inability to comprehend and/or perform any study-related, clinical vision function test
- Household member enrolled in present ICONICC study or treated within the past 6 months with any form of office-based vergence/accommodative therapy or home-based vergence therapy (e.g., computerized vergence therapy)
- Household member is an eye care professional, ophthalmic technician, ophthalmology or optometry resident or fellow, or optometry student

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