Interventions for Convergence Insufficiency in Concussed Children

NCT03908112 | Unknown Phase 3 DMC

• 1 other identifier: Salus 1003-2019
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

convergence insufficiency; concussion; vision therapy; vision rehabilitation

Outcome Measures

Primary Outcomes (1)

• Composite of Measure of the Near Point of Convergence (NPC) and Positive Fusional Vergence at Near (PFV)

  To evaluate successful treatment of CI, we will use a composite outcome classification of the 2 clinical outcome measures of NPC and PFV from baseline to the primary outcome examination. A participant will be defined as successfully treated if both criteria are met: 1) normal NPC (i.e., less than 6 cm) and 2) normal PFV (i.e., greater than 15 prism diopters base-out and passing Sheard's criterion

  12 weeks

Secondary Outcomes (7)

• Peak velocity for 4° symmetrical convergence steps

  12 weeks

• Time to peak velocity for 4° symmetrical convergence steps

  12 Weeks

• Latency for 4° symmetrical convergence steps

  12 weeks

• Response Amplitude for 4° symmetrical convergence steps

  12 weeks

• Convergence Insufficiency Symptom Survey - Concussion Version (CISS-CON)

  12 weeks

Study Arms (3)

Standard Community Concussion Care (SC)

ACTIVE COMPARATOR

Standard concussion care consists of physical and cognitive rest immediately following the injury for a brief period of time to allow symptoms to abate, followed by a gradual reintroduction of academic and physical activities, restricting activities at high risk for repeat brain injury (such as contact or collision sports) until a graded return to play protocol has been completed in a symptom-free manner.

Behavioral: Standard Community Concussion Care (SC)

SC plus Simple Convergence Procedures (SC+)

EXPERIMENTAL

In addition to the treatment described for SC, participants in this group will be asked to work with the Brock String, which is a popular and simple therapy technique designed to improve convergence. A 3-phase, graded Brock String procedure has been developed for ICONICC.

Behavioral: SC plus Simple Convergence Exercises (SC+)

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

EXPERIMENTAL

Office-based vergence accommodative therapy (OBVAT) is administered by a study certified therapist at weekly intervals (60-minute office visits with 55 minutes of therapy time), combined with procedures to practice at home for 15 minutes, 5 times per week.

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

Interventions

Standard Community Concussion Care (SC) BEHAVIORAL

temporary rest, gradual increase in activity, and return to school and sports. In some cases vestibular an balance therapy are necessary, aerobic exercises, medication, counseling.

Also known as: Concussion treatment

Standard Community Concussion Care (SC)

SC plus Simple Convergence Exercises (SC+) BEHAVIORAL

In addition to standard community care in this intervention the participants must perform convergence therapy every day at home

Also known as: Concussion care plus convergence exercises

SC plus Simple Convergence Procedures (SC+)

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

In addition to standard community care in this intervention the participants must come to the office once a week for a 1-hour therapy session with a therapist. Office-based vergence/accommodative therapy is performed for 12 weeks with home reinforcement.

Also known as: vision therapy

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

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mitchell Scheiman: lead
• Ohio State University: collaborator
• University of Alabama at Birmingham: collaborator
• Marshall B. Ketchum University: collaborator
• Stanford University: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Children's Hospital of Philadelphia: collaborator
• Boston Children's Hospital: collaborator
• New Jersey Institute of Technology: collaborator

Study Sites (8)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

Marshall B. Ketchum University, Southern CA College of Optomwtry

Fullerton, California, 92831, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Boston's Children's Hospital

Boston, Massachusetts, 02453, United States

Location

New Jersey Institute of Technology

Newark, New Jersey, 07102, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

Salus University/Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Brain Concussion; Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Cranial Nerve Diseases; Eye Diseases

Study Officials

• Mitchell Scheiman, OD, PhD

  Salus University

  STUDY CHAIR

Central Study Contacts

Mitchell Scheiman, OD, PhD

CONTACT

215-780-1427; mscheiman@salus.edu

Wendy Woodward

CONTACT

215-780-1429; wwoodward@salus.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be masked to the treatment assignment and at follow-up examinations the examiners will be masked to the treatment group assignment. Investigators providing the therapy will be unmasked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dean of Research

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 9, 2019
• Study Start: April 1, 2021
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)