Effect of Vergence Exercises for Patients With Convergence Insufficiency After Concussion.

Study Overview
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Brief Summary
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A large proportion of concussion patients with long-term consequences of concussion experience visually related symptoms such as headache, blurred vision, double vision, and fatigue. These patients often have difficulties coordinating the movement of the two eyes (convergence insufficiency) which is essential for single and clear vision to be obtained and is hence a likely explanation for the symptoms. 100 patients with long-term symptoms of concussion and convergence insufficiency will be offered either exercises or placebo treatment the evaluate the effect of exercises aimed at improving coordination between the two eyes. The study will provide data to support clinicians in deciding whether to use exercises or not as a treatment of symptoms for patients with convergence insufficiency as a long-term consequence of concussion.

Official Title
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Effect of Vergence Exercises for Rehabilitation of Patients With Convergence Insufficiency as a Long-term Consequence of Concussion.

Conditions
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Concussion, Mild, Convergence Insufficiency

Intervention / Treatment
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* Other: Vergence exercises (Orthoptic exercises)
* Genetic: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Concussion at least 3 month ago Convergence insufficiency which has not been diagnosed prior to the concussion Exclusion Criteria: Patient who are unable to fulfill baseline examination Manifest or paralytic strabismus Self-reported eye disease

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vergence exercises<br>Orthoptic vergence exercises | Other: Vergence exercises (Orthoptic exercises)<br>* Vergence exercises as described by the Convergence Insufficiency Treatment Trials Group (CITT)<br>|
| Placebo Comparator: Generic treatment<br> | Genetic: Placebo<br>* Generic management plan with non-visual elements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Convergence Insufficiency Symptom Survey (CISS) week 18 | Questionnaire assessing the frequency of eye and visually related symptom during near work | Duration (5 minutes) and performed at week 18 | 
| Convergence Insufficiency Symptom Survey (CISS) week 36 | Questionnaire assessing the frequency of eye and visually related symptom during near work | Duration (5 minutes) and performed at week 36 | 
| Near point of convergence - week 18 | Psychophysical test of the eyes ability to converge | Duration (2 minutes) and performed at week 18 | 
| Near point of convergence - week 36 | Psychophysical test of the eyes ability to converge | Duration (2 minutes) and performed at week 36 | 
| Positive fusional vergence at 40 cm - week 18 | Psychophysical test of the slow fusional adaptation | Duration (2 minutes) and performed at week 18 | 
| Positive fusional vergence at 40 cm - week 36 | Psychophysical test of the slow fusional adaptation | Duration (2 minutes) and performed at week 36 | 
| Vergence facility at 40 cm - week 18 | Psychophysical test of fast fusional adaptation | Duration (2 minutes) and performed at week 18 | 
| Vergence facility at 40 cm - week 36 | Psychophysical test of fast fusional adaptation | Duration (2 minutes) and performed at week 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rivermead post-concussional symptoms questionnaire (RPQ) - week 18 | Questionnaire assessing the frequency of symptoms during activities of daily living | Duration (5 minutes) and performed at week 18 | 
| Rivermead post-concussional symptoms questionnaire (RPQ) - week 36 | Questionnaire assessing the frequency of symptoms during activities of daily living | Duration (5 minutes) and performed at week 36 |