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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

Must not have

History of surgery or botulinum toxin for strabismus or any type of refractive surgery

Any strabismus at distance

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My eyes struggle to focus on close objects without drifting apart.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have misaligned eyes when looking far away.

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I have involuntary eye movements.

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I have limited eye movement due to a muscle condition.

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I am able to understand and perform vision tests required by the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Latency for 4° symmetrical convergence steps

Peak velocity for 4° symmetrical convergence steps

+4 more

Awards & Highlights

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.

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.

0 / 6Eligibility criteria met