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

Not Applicable

Recruiting

• Conditions: Concussion, Mild; Convergence Insufficiency

• Registration Number: NCT05012384
• Lead Sponsor: Danish College of Optometry and Vision Science

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-19
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11
• Primary Completion: 2024-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
Vergence facility at 40 cm - week 36	Duration (2 minutes) and performed at week 36	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
Near point of convergence - week 18	Duration (2 minutes) and performed at week 18	Psychophysical test of the eyes ability to converge
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Danish College of Optometry and Vision Science; 🇩🇰 Randers, Central Region, Denmark, Denmark