Interventions for Convergence Insufficiency in Concussed Children

Concussion Clinical Trial

— ICONICC  

Official title:

Interventions for Convergence Insufficiency in Concussed Children (ICONICC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03908112
• Other study ID #: Salus 1003-2019
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 1, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: October 2020
• Source: Salus University
• Contact: Mitchell Scheiman, OD, PhD
• Phone: 215-780-1427
• Email: mscheiman[@]salus.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 264
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Concussion
• Convergence Insufficiency
• Ocular Motility Disorders

Intervention

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.
• SC plus Simple Convergence Exercises (SC+)
In addition to standard community care in this intervention the participants must perform convergence therapy every day at home
• SC plus Office-based Vergence/Accommodative Therapy (SC+OBVAT)
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.

Locations

Country	Name	City	State
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Boston's Children's Hospital	Boston	Massachusetts
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	The Ohio State University College of Optometry	Columbus	Ohio
United States	Marshall B. Ketchum University, Southern CA College of Optomwtry	Fullerton	California
United States	New Jersey Institute of Technology	Newark	New Jersey
United States	Stanford University Medical Center	Palo Alto	California
United States	Salus University/Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (9)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	12 weeks
Secondary	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	12 Weeks
Secondary	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	12 weeks
Secondary	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	12 weeks
Secondary	Convergence Insufficiency Symptom Survey - Concussion Version (CISS-CON)	The change in the score on this survey will be a secondary outcome assessing symptoms	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 Weeks