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

Concussion, Mild Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05012384
• Other study ID #: 1-10-72-22-21
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: August 1, 2025

Study information

• Verified date: September 2023
• Source: Danish College of Optometry and Vision Science
• Contact: Marianne L Maagaard, MSc
• Phone: +45 22 91 92 01
• Email: mlm[@]eadania.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Mild
• Convergence Insufficiency
• Ocular Motility Disorders

Intervention

Other:
• Vergence exercises (Orthoptic exercises)
Vergence exercises as described by the Convergence Insufficiency Treatment Trials Group (CITT)

Genetic:
• Placebo
Generic management plan with non-visual elements

Locations

Country	Name	City	State
Denmark	Danish College of Optometry and Vision Science	Randers	Central Region, Denmark

Sponsors (1)

Lead Sponsor	Collaborator
Danish College of Optometry and Vision Science

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Near point of convergence - week 18	Psychophysical test of the eyes ability to converge	Duration (2 minutes) and performed at week 18
Primary	Near point of convergence - week 36	Psychophysical test of the eyes ability to converge	Duration (2 minutes) and performed at week 36
Primary	Positive fusional vergence at 40 cm - week 18	Psychophysical test of the slow fusional adaptation	Duration (2 minutes) and performed at week 18
Primary	Positive fusional vergence at 40 cm - week 36	Psychophysical test of the slow fusional adaptation	Duration (2 minutes) and performed at week 36
Primary	Vergence facility at 40 cm - week 18	Psychophysical test of fast fusional adaptation	Duration (2 minutes) and performed at week 18
Primary	Vergence facility at 40 cm - week 36	Psychophysical test of fast fusional adaptation	Duration (2 minutes) and performed at week 36
Secondary	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
Secondary	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