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Interventions for Convergence Insufficiency in Children with Concussions (ICONICC Trial)
Phase 3
Waitlist Available
Research Sponsored by Mitchell Scheiman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Receded near point of convergence (NPC) of greater than 6 cm break
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
ICONICC Trial Summary
This trial is designed to compare the standard care for concussions with two additional treatments in children aged 11-17. The study will also compare the effect of treatment on various symptoms, quality of life, and eye movement recordings.
Who is the study for?
This trial is for children aged 11 to 17 with post-concussion syndrome (4-12 weeks after injury) who have specific eye movement disorders like convergence insufficiency. They must have good visual acuity, be willing to wear or not wear certain eyewear as required, and cannot have had previous treatments that affect eye movements.Check my eligibility
What is being tested?
The ICONICC Study tests if adding simple convergence exercises or office-based therapy to standard concussion care helps kids with symptomatic post-concussion syndrome better than standard care alone. It's a randomized trial where participants are equally divided into three groups for a 12-week treatment program.See study design
What are the potential side effects?
Since the interventions involve non-invasive therapies such as exercises and office-based treatments, side effects may include temporary eye strain or headaches due to the nature of vision-related activities but are generally minimal.
ICONICC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My eyes struggle to focus on close objects without drifting apart.
ICONICC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite of Measure of the Near Point of Convergence (NPC) and Positive Fusional Vergence at Near (PFV)
Secondary outcome measures
Convergence Insufficiency Symptom Survey - Concussion Version (CISS-CON)
Latency for 4° symmetrical convergence steps
Peak velocity for 4° symmetrical convergence steps
+4 moreICONICC Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: SC plus Simple Convergence Procedures (SC+)Experimental Treatment1 Intervention
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.
Group II: SC plus Office-based Vergence/Accommodative Therapy (SC+VAT)Experimental Treatment1 Intervention
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.
Group III: Standard Community Concussion Care (SC)Active Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Children's Hospital of PhiladelphiaOTHER
707 Previous Clinical Trials
8,581,027 Total Patients Enrolled
Boston Children's HospitalOTHER
759 Previous Clinical Trials
5,579,296 Total Patients Enrolled
Marshall B. Ketchum UniversityUNKNOWN
1 Previous Clinical Trials
311 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a child aged 11 to 17.My child and I understand the study and agree to the treatment assignment by chance.You have a score of 16 or higher on the CI Symptom Survey.Your pupils respond normally to light.I have had surgery or Botox for eye alignment or any vision correction surgery.I was diagnosed with a concussion between 4 and 12 weeks ago.You have a certain eye alignment issue at a certain distance.I am willing to stop using my current near vision correction method for the study.You have a constant eye turn when looking at things up close.A family member is part of the ICONICC study or had eye therapy in the last 6 months.You have a specific eye condition where your eyes are misaligned by a certain amount.I have misaligned eyes when looking far away.You can see clearly at a distance with glasses or contact lenses.My eyes struggle to focus on close objects without drifting apart.Your eyes turn outward more when looking at things up close compared to looking at things far away.I have involuntary eye movements.I have limited eye movement due to a muscle condition.You have trouble bringing your eyes together when looking at things up close.You can see 3D pictures clearly with a special test.You were diagnosed with a vision problem by an eye doctor before having a concussion.Someone in your household works in eye care or is studying to work in eye care.I do not have conditions like MS, thyroid eye disease, or diabetes that affect eye movement.Your eyes have a big difference in how well they can see, even with glasses.I am able to understand and perform vision tests required by the study.I am willing to wear glasses or contacts for my vision problem.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Community Concussion Care (SC)
- Group 2: SC plus Simple Convergence Procedures (SC+)
- Group 3: SC plus Office-based Vergence/Accommodative Therapy (SC+VAT)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project test people who are over twenty-five?
"According to the requirements for joining this clinical trial, eligible patients must be aged between 11 and 17."
Answered by AI
Could you list the different states in which this trial is being conducted?
"Currently, there are 8 locations where this clinical trial is enrolling patients. The sites are located in Boston, Cincinnati, Fullerton, and 8 other locations. If you are interested in participating, it may be helpful to choose a site that is nearest to you to minimize travel requirements."
Answered by AI
Which patients are qualified to take part in this research?
"This study is looking for 264 participants aged 11-17 who have opsoclonus. The following criteria must be met: Insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard's criterion1 or PFV ≤15∆ base-out break), Medical diagnosis of concussion of at least 4 weeks and no longer than 12 weeks since known date of injury, Exophoria at near at least 4∆ greater than at far, Receded near point of convergence (NPC) of greater than 6 cm break, Best-corrected distance visual acuity of 20/25"
Answered by AI
Are people with the required afflictions currently being accepted into this trial?
"No, this study is not currently recruiting patients for participation, as noted in the clinicaltrials.gov posting from April 1st, 2021. The last update to the posting was on October 22th, 2020. There are, however, 14 other trials that are recruiting patients."
Answered by AI
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