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

NCT05012384 | Unknown

• 1 other identifier: 1-10-72-22-21
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Mild; Convergence Insufficiency

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• Rivermead post-concussional symptoms questionnaire (RPQ) - week 18

  Duration (5 minutes) and performed at week 18

• Rivermead post-concussional symptoms questionnaire (RPQ) - week 36

  Duration (5 minutes) and performed at week 36

Study Arms (2)

Vergence exercises

EXPERIMENTAL

Orthoptic vergence exercises

Other: Vergence exercises (Orthoptic exercises)

Generic treatment

PLACEBO COMPARATOR

Genetic: Placebo

Interventions

Vergence exercises (Orthoptic exercises) OTHER

Vergence exercises as described by the Convergence Insufficiency Treatment Trials Group (CITT)

Vergence exercises

Placebo GENETIC

Generic management plan with non-visual elements

Generic treatment

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Concussion at least 3 month ago
• Convergence insufficiency which has not been diagnosed prior to the concussion

You may not qualify if:

• Patient who are unable to fulfill baseline examination
• Manifest or paralytic strabismus
• Self-reported eye disease

Sponsors & Collaborators

• Danish College of Optometry and Vision Science: lead

Study Sites (1)

Danish College of Optometry and Vision Science

Randers, Central Region, Denmark, 8960, Denmark

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Cranial Nerve Diseases; Eye Diseases

Central Study Contacts

Marianne L Maagaard, MSc

CONTACT

+45 22 91 92 01; mlm@eadania.dk

Ivan Nisted, MPH

CONTACT

+45 30 82 57 64; ivn@eadania.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: August 19, 2021
• Study Start: July 1, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

DK (1)