Interventions for Convergence Insufficiency in Children with Concussions

(ICONICC Trial)

Not currently recruiting at 7 trial locations

Overseen By Wendy Woodward

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Mitchell Scheiman

Disqualifiers: Strabismus, Nystagmus, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 6 7}

Who 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

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.

Exclusion Criteria

I have had surgery or Botox for eye alignment or any vision correction surgery.

You have a certain eye alignment issue at a certain distance.

You have a constant eye turn when looking at things up close.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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)

Trial Overview

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.

How Is the Trial Designed?

Group I: SC plus Simple Convergence Procedures (SC+) Experimental Treatment 1 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 Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Mitchell Scheiman

Lead Sponsor

Trials

1

Recruited

260+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Marshall B. Ketchum University

Collaborator

Trials

2

Recruited

580+

New Jersey Institute of Technology

Collaborator

Trials

11

Recruited

1,100+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03908112

Interventions for Convergence Insufficiency in Concussed ...

Primary Objective: To compare the effectiveness of SC, SC+, SC plus office-based vergence/accommodative therapy for improving a composite outcome measure of ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2779032/

A Randomized Clinical Trial of Treatments for Symptomatic ...

Twelve weeks of OBVAT results in a significantly greater improvement in symptoms and clinical measures of NPC and PFV and a greater percentage of patients ...

3.

abseevision.com

abseevision.com/storage/app/media/SKM_C284e16033017490.pdf

CLINICAL TRIALS - A B See Vision Therapy Center, S.C.

Conclusions: Twelve weeks of OBVAT results in a sig- nificantly greater improvement in symptoms and clini- cal measures of near point of convergence and ...

4.

ctv.veeva.com

ctv.veeva.com/study/interventions-for-convergence-insufficiency-in-concussed-children

Interventions for Convergence Insufficiency in Concussed ...

Behavioral: SC plus Office-based Vergence/Accommodative Therapy (SC+OBVAT) ... Primary Objective: To compare the effectiveness of SC, SC+, SC plus ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41033748/

CONCUSS randomised clinical trial of vergence/ ...

Objective: The CONCUSS randomised clinical trial compared the effectiveness of immediate office-based vergence/accommodative therapy with ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3204163/

Treatment of Accommodative Dysfunction in Children

Herein, we report the effectiveness of office-based vergence/accommodative therapy (OBVAT), home-based computer vergence/accommodative therapy plus pencil push- ...

7.

med.stanford.edu

med.stanford.edu/content/sm/mosslab/research.html?start=2580

Research | Moss Lab - Stanford Medicine

Interventions for Convergence Insufficiency in Concussed Children. The ... accommodative therapy SC+OBVAT (1:1:1 ratio). The study will also compare ...