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

Primary Purpose

Concussion, Mild, Convergence Insufficiency

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Vergence exercises (Orthoptic exercises)
Placebo
Sponsored by
Danish College of Optometry and Vision Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Concussion, Mild

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Danish College of Optometry and Vision ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vergence exercises

Generic treatment

Arm Description

Orthoptic vergence exercises

Outcomes

Primary Outcome Measures

Convergence Insufficiency Symptom Survey (CISS) week 18
Questionnaire assessing the frequency of eye and visually related symptom during near work
Convergence Insufficiency Symptom Survey (CISS) week 36
Questionnaire assessing the frequency of eye and visually related symptom during near work
Near point of convergence - week 18
Psychophysical test of the eyes ability to converge
Near point of convergence - week 36
Psychophysical test of the eyes ability to converge
Positive fusional vergence at 40 cm - week 18
Psychophysical test of the slow fusional adaptation
Positive fusional vergence at 40 cm - week 36
Psychophysical test of the slow fusional adaptation
Vergence facility at 40 cm - week 18
Psychophysical test of fast fusional adaptation
Vergence facility at 40 cm - week 36
Psychophysical test of fast fusional adaptation

Secondary Outcome Measures

Rivermead post-concussional symptoms questionnaire (RPQ) - week 18
Questionnaire assessing the frequency of symptoms during activities of daily living
Rivermead post-concussional symptoms questionnaire (RPQ) - week 36
Questionnaire assessing the frequency of symptoms during activities of daily living

Full Information

First Posted
July 8, 2021
Last Updated
September 8, 2023
Sponsor
Danish College of Optometry and Vision Science
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1. Study Identification

Unique Protocol Identification Number
NCT05012384
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danish College of Optometry and Vision Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild, Convergence Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vergence exercises
Arm Type
Experimental
Arm Description
Orthoptic vergence exercises
Arm Title
Generic treatment
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Vergence exercises (Orthoptic exercises)
Intervention Description
Vergence exercises as described by the Convergence Insufficiency Treatment Trials Group (CITT)
Intervention Type
Genetic
Intervention Name(s)
Placebo
Intervention Description
Generic management plan with non-visual elements
Primary Outcome Measure Information:
Title
Convergence Insufficiency Symptom Survey (CISS) week 18
Description
Questionnaire assessing the frequency of eye and visually related symptom during near work
Time Frame
Duration (5 minutes) and performed at week 18
Title
Convergence Insufficiency Symptom Survey (CISS) week 36
Description
Questionnaire assessing the frequency of eye and visually related symptom during near work
Time Frame
Duration (5 minutes) and performed at week 36
Title
Near point of convergence - week 18
Description
Psychophysical test of the eyes ability to converge
Time Frame
Duration (2 minutes) and performed at week 18
Title
Near point of convergence - week 36
Description
Psychophysical test of the eyes ability to converge
Time Frame
Duration (2 minutes) and performed at week 36
Title
Positive fusional vergence at 40 cm - week 18
Description
Psychophysical test of the slow fusional adaptation
Time Frame
Duration (2 minutes) and performed at week 18
Title
Positive fusional vergence at 40 cm - week 36
Description
Psychophysical test of the slow fusional adaptation
Time Frame
Duration (2 minutes) and performed at week 36
Title
Vergence facility at 40 cm - week 18
Description
Psychophysical test of fast fusional adaptation
Time Frame
Duration (2 minutes) and performed at week 18
Title
Vergence facility at 40 cm - week 36
Description
Psychophysical test of fast fusional adaptation
Time Frame
Duration (2 minutes) and performed at week 36
Secondary Outcome Measure Information:
Title
Rivermead post-concussional symptoms questionnaire (RPQ) - week 18
Description
Questionnaire assessing the frequency of symptoms during activities of daily living
Time Frame
Duration (5 minutes) and performed at week 18
Title
Rivermead post-concussional symptoms questionnaire (RPQ) - week 36
Description
Questionnaire assessing the frequency of symptoms during activities of daily living
Time Frame
Duration (5 minutes) and performed at week 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marianne L Maagaard, MSc
Phone
+45 22 91 92 01
Email
mlm@eadania.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Ivan Nisted, MPH
Phone
+45 30 82 57 64
Email
ivn@eadania.dk
Facility Information:
Facility Name
Danish College of Optometry and Vision Science
City
Randers
State/Province
Central Region, Denmark
ZIP/Postal Code
8960
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Ledet Maagaard, MSc
Phone
+45 22919201
Email
mlm@eadania.dk
First Name & Middle Initial & Last Name & Degree
Ivan Nisted, MSc
Phone
30825764
Email
ivn@eadania.dk

12. IPD Sharing Statement

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

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