Clinical trial NCT05012384: Effect of Vergence Exercises for Patients With Convergence Insufficiency After Concussion.
Official title: Effect of Vergence Exercises for Rehabilitation of Patients With Convergence Insufficiency as a Long-term Consequence of Concussion.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Concussion, Mild
Convergence Insufficiency
Lead sponsor: Danish College of Optometry and Vision Science
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Convergence Insufficiency Symptom Survey (CISS) week 18
timeFrame: Duration (5 minutes) and performed at week 18
measure: Convergence Insufficiency Symptom Survey (CISS) week 36
timeFrame: Duration (5 minutes) and performed at week 36
measure: Near point of convergence - week 18
timeFrame: Duration (2 minutes) and performed at week 18
measure: Near point of convergence - week 36
timeFrame: Duration (2 minutes) and performed at week 36
measure: Positive fusional vergence at 40 cm - week 18
timeFrame: Duration (2 minutes) and performed at week 18
measure: Positive fusional vergence at 40 cm - week 36
timeFrame: Duration (2 minutes) and performed at week 36
measure: Vergence facility at 40 cm - week 18
timeFrame: Duration (2 minutes) and performed at week 18
measure: Vergence facility at 40 cm - week 36
timeFrame: Duration (2 minutes) and performed at week 36
Secondary outcomes:
measure: Rivermead post-concussional symptoms questionnaire (RPQ) - week 18
timeFrame: Duration (5 minutes) and performed at week 18
measure: Rivermead post-concussional symptoms questionnaire (RPQ) - week 36
timeFrame: Duration (5 minutes) and performed at week 36
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Danish College of Optometry and Vision Science
state: Central Region, Denmark
Study officials:
References: