Effect of Vergence Exercises for Patients With Convergence Insufficiency After Concussion.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vergence exercises Orthoptic vergence exercises |
Other: Vergence exercises (Orthoptic exercises)
Vergence exercises as described by the Convergence Insufficiency Treatment Trials Group (CITT)
|
| Placebo Comparator: Generic treatment
|
Genetic: Placebo
Generic management plan with non-visual elements
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Vergence facility at 40 cm - week 36 [Duration (2 minutes) and performed at week 36]
Psychophysical test of fast fusional adaptation
Secondary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Danish College of Optometry and Vision Science | Randers | Central Region, Denmark | Denmark | 8960 |
Sponsors and Collaborators
- Danish College of Optometry and Vision Science
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1-10-72-22-21