Interventions for Convergence Insufficiency in Children with Concussions
(ICONICC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores treatments for children with lingering vision issues after a concussion, known as convergence insufficiency (CI). It aims to determine which treatment approach works best: standard concussion care alone, with simple eye exercises, or with office-based vision therapy. Children aged 11 to 17 who have had a concussion in the last 4 to 12 weeks and experience symptoms like double vision or headaches might be suitable candidates. The goal is to find the most effective way to relieve symptoms and improve quality of life for these children. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must be willing to stop using BI prism or a plus add at near for the duration of the study, at least 2 weeks before the eligibility examination.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both SC with Simple Convergence Exercises and SC with Office-based Vergence/Accommodative Therapy are generally well-tolerated by children. The office-based therapy proved effective for children with eye alignment and focus problems after a concussion. Delivered in weekly sessions, this therapy includes activities both in the office and at home.
Simple convergence exercises use easy techniques like the Brock String to improve eye coordination. Although detailed information on side effects is limited, these exercises are considered safe and have been used in similar situations without major issues.
Since the trial is in an advanced stage, earlier studies likely identified any serious side effects. Overall, these treatments appear safe, with no significant reports of adverse events.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer targeted therapies for children with convergence insufficiency after a concussion. Unlike the standard of care, which focuses on rest and gradual reintroduction to activities, SC plus Office-based Vergence/Accommodative Therapy (SC+OBVAT) involves structured, therapist-led sessions that enhance eye coordination and focus through specific exercises. Meanwhile, SC plus Simple Convergence Exercises (SC+) introduces the Brock String technique, a straightforward, home-based method to improve eye convergence. These approaches aim to directly address the visual symptoms associated with concussions, potentially speeding up recovery and improving quality of life.
What evidence suggests that this trial's treatments could be effective for convergence insufficiency in children with concussions?
Research shows that office-based vergence/accommodative therapy (OBVAT), which participants in this trial may receive, effectively treats convergence insufficiency, especially in children with concussions. Studies have found that twelve weeks of OBVAT significantly improve symptoms and enhance the eyes' ability to focus on close objects. Patients receiving OBVAT often report a greater reduction in symptoms compared to other treatments.
Another treatment arm in this trial involves simple exercises like the Brock String. Although these exercises are popular, evidence suggests that more intensive therapies like OBVAT might lead to better results. While simple exercises can show some improvement, OBVAT is linked to a higher success rate. Overall, the data supports OBVAT's effectiveness in addressing specific eye problems related to post-concussion syndrome in children.12367Who Is on the Research Team?
Mitchell Scheiman, OD, PhD
Principal Investigator
Salus University
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to a 12-week treatment program of either standard concussion care, standard care plus simple convergence procedures, or standard care plus office-based vergence/accommodative therapy.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SC plus Office-based Vergence/Accommodative Therapy (SC+OBVAT)
- SC plus Simple Convergence Exercises (SC+)
- Standard Community Concussion Care (SC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mitchell Scheiman
Lead Sponsor
Children's Hospital of Philadelphia
Collaborator
Boston Children's Hospital
Collaborator
Marshall B. Ketchum University
Collaborator
New Jersey Institute of Technology
Collaborator
Stanford University
Collaborator
Children's Hospital Medical Center, Cincinnati
Collaborator
Ohio State University
Collaborator
University of Alabama at Birmingham
Collaborator