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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Concussion, Mild; Convergence Insufficiency
• Intervention / Treatment: Other: Vergence exercises (Orthoptic exercises); Genetic: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marianne L Maagaard, MSc; Phone Number: +45 22 91 92 01; Email: mlm@eadania.dk
• Study Contact Backup: Name: Ivan Nisted, MPH; Phone Number: +45 30 82 57 64; Email: ivn@eadania.dk

Study Locations

• Denmark
  • Central Region, Denmark
    • Randers, Central Region, Denmark, Denmark, 8960
      • Recruiting
      • Danish College of Optometry and Vision Science
      • Contact: Marianne Ledet Maagaard, MSc; Phone Number: +45 22919201; Email: mlm@eadania.dk
      • Contact: Ivan Nisted, MSc; Phone Number: 30825764; Email: ivn@eadania.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Danish College of Optometry and Vision Science

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Cranial Nerve Diseases; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Ocular Motility Disorders
• Other Study ID Numbers: 1-10-72-22-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No