Concussion, Mild, Convergence Insufficiency
Conditions
Brief summary
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.
Interventions
OTHERVergence exercises (Orthoptic exercises)
Vergence exercises as described by the Convergence Insufficiency Treatment Trials Group (CITT)
GENETICPlacebo
Generic management plan with non-visual elements
Sponsors
Danish College of Optometry and Vision Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vergence facility at 40 cm - week 36 | Duration (2 minutes) and performed at week 36 | Psychophysical test of fast fusional adaptation |
| Positive fusional vergence at 40 cm - week 36 | Duration (2 minutes) and performed at week 36 | Psychophysical test of the slow fusional adaptation |
| Vergence facility at 40 cm - week 18 | Duration (2 minutes) and performed at week 18 | Psychophysical test of fast fusional adaptation |
| Convergence Insufficiency Symptom Survey (CISS) week 18 | Duration (5 minutes) and performed at week 18 | Questionnaire assessing the frequency of eye and visually related symptom during near work |
| Convergence Insufficiency Symptom Survey (CISS) week 36 | Duration (5 minutes) and performed at week 36 | Questionnaire assessing the frequency of eye and visually related symptom during near work |
| Near point of convergence - week 18 | Duration (2 minutes) and performed at week 18 | Psychophysical test of the eyes ability to converge |
| Near point of convergence - week 36 | Duration (2 minutes) and performed at week 36 | Psychophysical test of the eyes ability to converge |
| Positive fusional vergence at 40 cm - week 18 | Duration (2 minutes) and performed at week 18 | Psychophysical test of the slow fusional adaptation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rivermead post-concussional symptoms questionnaire (RPQ) - week 36 | Duration (5 minutes) and performed at week 36 | Questionnaire assessing the frequency of symptoms during activities of daily living |
| Rivermead post-concussional symptoms questionnaire (RPQ) - week 18 | Duration (5 minutes) and performed at week 18 | Questionnaire assessing the frequency of symptoms during activities of daily living |
Countries
Denmark
Contacts
Primary ContactMarianne L Maagaard, MSc
Backup ContactIvan Nisted, MPH
Outcome results
None listed