Current Environment:

Alert

ENFit Feeding Tube Adapters

GI Feeding Tube Users: if you do not have ENFit tubes, you may need an adapter to deliver feeds or medications. Contact your pharmacy or home care company.

Summary

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.

Conditions

Concussion, Convergence Insufficiency

Recruitment Status

Not yet recruiting

Detailed Description

Objectives: A group of 264 diverse children, ages 11 to 17 years, with post-concussion syndrome (4-12 weeks post-concussion injury) and symptomatic CI will be enrolled from 6 sites from across the United States, will be randomized to 12 weeks of: 1) standard care (SC), 2) SC plus simple convergence exercises (SC+), and 3) SC plus office-based vergence/ accommodative therapy (SC+OBVAT). Primary Objective: To compare the effectiveness of SC, SC+, SC plus office-based vergence/accommodative therapy for improving a composite outcome measure of clinical findings (near point of convergence and positive fusional vergence at near) in children 11-17 years of age with concussion-related CI after 12 weeks of treatment. Secondary outcome measures Objective measures of disparity vergence, accommodation, saccades, and smooth pursuit Quality of life measures Convergence Insufficiency Symptom Survey Concussion Version (CISS-CON) PedsQL Version 4 For participants in any treatment group who not "successful" based on the composite score described above, additional/different treatment will be offered as an option after the primary outcome examination

Eligibility Criteria

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

Intervention

Intervention Type

Intervention Name

Behavioral

Standard Community Concussion Care (SC)

Behavioral

SC plus Simple Convergence Exercises (SC+)

Behavioral

SC plus Office-based Vergence/Accommodative Therapy (SC+OBVAT)

Phase

Phase 3

Gender

All

Min Age

11 Years

Max Age

17 Years

Download Date

October 23, 2020

Principal Investigator

Mitchell Scheiman

Primary Contact Information

Mitchell Scheiman, OD, PhD

215-780-1427

mscheiman@salus.edu

Wendy Woodward

215-780-1429

wwoodward@salus.edu

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: