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Interventions for Concussion-Related Convergence Insufficiency in Children (ICONICC)

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ClinicalTrials.gov Identifier: NCT03908112
Recruitment Status : Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Collaborators:
Ohio State University
University of Alabama at Birmingham
Marshall B. Ketchum University
Stanford University
Children's Hospital Medical Center, Cincinnati
Children's Hospital of Philadelphia
Boston Children’s Hospital
New Jersey Institute of Technology
Information provided by (Responsible Party):
Mitchell Scheiman, Salus University

Brief Summary:
ICONICC is a randomized controlled clinical trial designed to test the primary hypothesis that standard concussion care plus office-based vergence/accommodative therapy (SC+VAT) is more effective than either standard concussion care alone (SC) or standard concussion care plus simple convergence procedures (SC+) for improving the near point of convergence and positive fusional vergence at near in concussion-related convergence insufficiency in children aged 11 to 17 years. Children with post-concussion syndrome (4-12 weeks post-concussion injury) and symptomatic convergence insufficiency 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+VAT.

Condition or disease Intervention/treatment Phase
Concussion Convergence Insufficiency Behavioral: Standard Community Concussion Care (SC) Behavioral: SC plus Simple Convergence Procedures (SC+) Behavioral: SC plus Office-based Vergence/Accommodative Therapy (SC+VAT) Phase 3

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.

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 Objectives:

  • To investigate changes in

    • objective measures of vergence, accommodation, saccades
    • symptoms
    • quality of life measures
    • accommodative function
    • saccadic eye movements
  • To study the underlying mechanisms and physiological changes that occur in oculomotor function after treatment with SC+VAT as compared to SC+ and to SC.
  • Explore aerobic tolerance and its effect on accommodation and convergence insufficiency
  • To study the natural history of concussion-related convergence insufficiency by following the SC group that will receive no specific treatment for the convergence insufficiency.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Interventions for Concussion-Related Convergence Insufficiency in Children (ICONICC)
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025


Arm Intervention/treatment
Active Comparator: Standard Community Concussion Care (SC)
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)
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.
Other Name: Concussion treatment

Experimental: SC plus Simple Convergence Procedures (SC+)
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 Procedures (SC+)
In addition to standard community care in this intervention the participants must perform convergence therapy every day at home
Other Name: Concussion care plus convergence exercises

Experimental: SC plus Office-based Vergence/Accommodative Therapy (SC+VAT)
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+VAT)
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.
Other Name: vision therapy




Primary Outcome Measures :
  1. Composite of Measure of the Near Point of Convergence (NPC) and Positive Fusional Vergence at Near (PFV) [ Time Frame: 12 weeks ]
    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


Secondary Outcome Measures :
  1. Peak velocity for 4° symmetrical convergence steps [ Time Frame: 12 weeks ]
    The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Peak velocity will be measured with this instrument and a secondary outcome measures will be the change in peak velocity for 4° symmetrical convergence steps

  2. Time to peak velocity for 4° symmetrical convergence steps [ Time Frame: 12 Weeks ]
    The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in time to peak velocity for 4° symmetrical convergence steps

  3. Latency for 4° symmetrical convergence steps [ Time Frame: 12 weeks ]
    The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in latency for 4° symmetrical convergence steps

  4. Response Amplitude for 4° symmetrical convergence steps [ Time Frame: 12 weeks ]
    The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in response amplitude for 4° symmetrical convergence steps

  5. Settling time for 4° symmetrical convergence steps [ Time Frame: 12 weeks ]
    The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in settling time for 4° symmetrical convergence steps

  6. Convergence Insufficiency Symptom Survey - Concussion Version (CISS-CON) [ Time Frame: 12 weeks ]
    The change in the score on this survey will be a secondary outcome assessing symptoms

  7. VisQual-T Quality of Life Survey [ Time Frame: 12 weeks ]
    The change in the score on this survey will be a secondary outcome assessing symptoms

  8. Post-concussion Symptom Inventory (PCSI) [ Time Frame: 12 weeks ]
    PCSI is a 26-item validated symptom inventory for children with concussion that identifies physical, cognitive, emotional and sleep factors following injury and is useful in capturing and tracking post-injury symptoms through recovery. The change in this score will be used as a secondary outcome measure.

  9. PROMIS® Pediatric Anxiety and Depression Subscales [ Time Frame: 12 Weeks ]
    PROMIS (Patient-Reported Outcomes Measurement Information System), developed by the NIH, is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. We will be using the PROMIS Pediatric Anxiety and Depression subscale which are a collection of 8-item short forms assessing anxiety and depressive symptoms. The change in this score will be used as a secondary outcome measure.

  10. PedsQL (Pediatric Quality of Life Inventory) [ Time Frame: 12 Weeks ]
    PedsQL (Pediatric Quality of Life Inventory) measures health-related quality of life (HRQOL) in children and adolescents. The change in this score will be used as a secondary outcome measure.



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  1. Medical diagnosis of concussion of at least 4 weeks and no longer than 12 weeks since known date of injury
  2. Age 11 to 17 years
  3. Gender - any
  4. CI Symptom Survey (CISS) score ≥ 16
  5. Exophoria at near at least 4∆ greater than at far
  6. Receded near point of convergence (NPC) of greater than 6 cm break
  7. Insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard's criterion1 or PFV ≤15∆ base-out break)
  8. Best-corrected distance visual acuity of 20/25 or better in each eye
  9. Random dot stereopsis appreciation of 500 seconds of arc or better using the Randot Stereotest
  10. 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
  11. Willing to discontinue BI prism or a plus add at near for duration of study (must discontinue at least 2 weeks before eligibility examination)
  12. Parent and child understand protocol and are willing to accept randomization
  13. Normal pupillary responses

Exclusion Criteria:

  1. Any strabismus at distance
  2. Constant strabismus at near
  3. Limitation on versions/ductions due to restrictive or paretic strabismus
  4. Esophoria of ≥ 2∆ at distance
  5. Vertical heterophoria ≥ 2∆ at distance or near
  6. ≥ 2 line interocular difference in best-corrected visual acuity
  7. Manifest or latent nystagmus
  8. History of surgery or botulinum toxin for strabismus or any type of refractive surgery
  9. Previous diagnosis of CI by an eye care professional before concussion
  10. Diseases known to affect accommodation, vergence, or ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, Parkinson's disease
  11. Inability to comprehend and/or perform any study-related, clinical vision function test
  12. 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)
  13. Household member is an eye care professional, ophthalmic technician, ophthalmology or optometry resident or fellow, or optometry student

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908112


Contacts
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Contact: Mitchell Scheiman, OD, PhD 215-780-1427 mscheiman@salus.edu
Contact: Wendy Woodward 215-780-1429 wwoodward@salus.edu

Locations
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United States, Alabama
University of Alabama Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Katherine Weise, OD    205-934-8964    kweise@uab.edu   
Principal Investigator: Katherine Weise, OD, MS         
Principal Investigator: Heath Hale, MD         
United States, California
Marshall B. Ketchum University, Southern CA College of Optomwtry Not yet recruiting
Fullerton, California, United States, 92831
Contact: Susan Cotter, OD, MS    714-463-7575    scotter@ketchum.edu   
Principal Investigator: Angela Chen, OD, MS         
Principal Investigator: Chris Kotures, MD         
Stanford University Medical Center Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Gerald Grant, MD         
Principal Investigator: Tawna Roberts, OD, PhD         
Principal Investigator: Gerald Grant, MD         
United States, Massachusetts
Boston's Children's Hospital
Boston, Massachusetts, United States, 02453
United States, New Jersey
New Jersey Institute of Technology Not yet recruiting
Newark, New Jersey, United States, 07102
Contact: Tara Alvarez, PhD         
Principal Investigator: Tara Alvarez, PhD         
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
The Ohio State University College of Optometry Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Lisa Jones-Jordan, PhD         
Principal Investigator: Lisa Jones-Jordan, PhD         
Principal Investigator: Gladys Lynn Mitchell, MAS         
United States, Pennsylvania
Salus University/Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
Mitchell Scheiman
Ohio State University
University of Alabama at Birmingham
Marshall B. Ketchum University
Stanford University
Children's Hospital Medical Center, Cincinnati
Children's Hospital of Philadelphia
Boston Children’s Hospital
New Jersey Institute of Technology
Investigators
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Study Chair: Mitchell Scheiman, OD, PhD Salus University

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Responsible Party: Mitchell Scheiman, Dean of Research, Salus University
ClinicalTrials.gov Identifier: NCT03908112     History of Changes
Other Study ID Numbers: Salus 1003-2019
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: A number assigned centrally by the CC will identify all enrolled participants. Participant data will be secured, all clinical sites, the CC, and the Resource Center in a manner to protect participant confidentiality. Only the PI, Clinic Coordinator, and Therapist will have access to the data at the clinical site. Data will be transmitted to the CC via a secure website, with the participant identified by his/her study ID number only. The informed consent document will inform all participants that their data will be sent to the Coordinating Center. Although results of the study will be presented at scientific meetings and reported in medical journals, at no time will any of the study participants be identified. The study will be monitored by the DSMC (see below) to ensure the safety of participants.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mitchell Scheiman, Salus University:
convergence insufficiency
concussion
vision therapy
vision rehabilitation

Additional relevant MeSH terms:
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Ocular Motility Disorders
Central Nervous System Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases