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Interventions for Convergence Insufficiency in Concussed Children (ICONICC)

Primary Purpose

Concussion, Convergence Insufficiency

Status

Not yet recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Standard Community Concussion Care (SC)

SC plus Simple Convergence Exercises (SC+)

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

About this trial

This is an interventional treatment trial for Concussion focused on measuring convergence insufficiency, concussion, vision therapy, vision rehabilitation

Eligibility Criteria

11 Years - 17 Years (Child)All SexesAccepts 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

Sites / Locations

University of Alabama Birmingham
Marshall B. Ketchum University, Southern CA College of Optomwtry
Stanford University Medical Center
Boston's Children's Hospital
New Jersey Institute of Technology
Cincinnati Children's Hospital Medical Center
The Ohio State University College of Optometry
Salus University/Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Standard Community Concussion Care (SC)

SC plus Simple Convergence Procedures (SC+)

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

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Peak velocity for 4° symmetrical convergence steps

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

Time to peak velocity for 4° symmetrical convergence steps

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

Latency for 4° symmetrical convergence steps

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

Response Amplitude for 4° symmetrical convergence steps

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

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

The change in the score on this survey will be a secondary outcome assessing symptoms

Post-concussion Symptom Inventory (PCSI)

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.

PedsQL (Pediatric Quality of Life Inventory)

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.

Full Information

NCT ID

NCT03908112

First Posted

April 4, 2019

Last Updated

October 22, 2020

Sponsor

Mitchell Scheiman

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

1. Study Identification

Unique Protocol Identification Number

NCT03908112

Brief Title

Interventions for Convergence Insufficiency in Concussed Children

Acronym

ICONICC

Official Title

Interventions for Convergence Insufficiency in Concussed Children (ICONICC)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 1, 2021 (Anticipated)

Primary Completion Date

March 31, 2025 (Anticipated)

Study Completion Date

March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mitchell Scheiman

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Concussion, Convergence Insufficiency

Keywords

convergence insufficiency, concussion, vision therapy, vision rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

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

ParticipantInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard Community Concussion Care (SC)

Arm Type

Active Comparator

Arm Description

Arm Title

SC plus Simple Convergence Procedures (SC+)

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Standard Community Concussion Care (SC)

Other Intervention Name(s)

Concussion treatment

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

SC plus Simple Convergence Exercises (SC+)

Other Intervention Name(s)

Concussion care plus convergence exercises

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

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

Other Intervention Name(s)

vision therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Peak velocity for 4° symmetrical convergence steps

Description

Time Frame

12 weeks

Title

Time to peak velocity for 4° symmetrical convergence steps

Description

Time Frame

12 Weeks

Title

Latency for 4° symmetrical convergence steps

Description

Time Frame

12 weeks

Title

Response Amplitude for 4° symmetrical convergence steps

Description

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

Time Frame

12 weeks

Title

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

Description

The change in the score on this survey will be a secondary outcome assessing symptoms

Time Frame

12 weeks

Title

Post-concussion Symptom Inventory (PCSI)

Description

Time Frame

12 weeks

Title

PedsQL (Pediatric Quality of Life Inventory)

Description

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.

Time Frame

12 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mitchell Scheiman, OD, PhD

Phone

215-780-1427

mscheiman@salus.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Wendy Woodward

Phone

215-780-1429

wwoodward@salus.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mitchell Scheiman, OD, PhD

Organizational Affiliation

Salus University

Official's Role

Study Chair

Facility Information:

Facility Name

University of Alabama Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katherine Weise, OD

Phone

205-934-8964

kweise@uab.edu

First Name & Middle Initial & Last Name & Degree

Katherine Weise, OD, MS

First Name & Middle Initial & Last Name & Degree

Heath Hale, MD

Facility Name

Marshall B. Ketchum University, Southern CA College of Optomwtry

City

Fullerton

State/Province

California

ZIP/Postal Code

92831

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Susan Cotter, OD, MS

Phone

714-463-7575

scotter@ketchum.edu

First Name & Middle Initial & Last Name & Degree

Angela Chen, OD, MS

First Name & Middle Initial & Last Name & Degree

Chris Kotures, MD

Facility Name

Stanford University Medical Center

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gerald Grant, MD

First Name & Middle Initial & Last Name & Degree

Tawna Roberts, OD, PhD

First Name & Middle Initial & Last Name & Degree

Gerald Grant, MD

Facility Name

Boston's Children's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02453

Country

United States

Facility Name

New Jersey Institute of Technology

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07102

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tara Alvarez, PhD

First Name & Middle Initial & Last Name & Degree

Tara Alvarez, PhD

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

The Ohio State University College of Optometry

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lisa Jones-Jordan, PhD

First Name & Middle Initial & Last Name & Degree

Lisa Jones-Jordan, PhD

First Name & Middle Initial & Last Name & Degree

Gladys Lynn Mitchell, MAS

Facility Name

Salus University/Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19141

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Learn more about this trial

Interventions for Convergence Insufficiency in Concussed Children

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