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

NCT ID: NCT05012384

Last Updated: 2023-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2025-08-01

Brief Summary

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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

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Conditions

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Concussion, Mild Convergence Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vergence exercises

Orthoptic vergence exercises

Group Type EXPERIMENTAL

Vergence exercises (Orthoptic exercises)

Intervention Type OTHER

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

Generic treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type GENETIC

Generic management plan with non-visual elements

Interventions

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Vergence exercises (Orthoptic exercises)

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

Intervention Type OTHER

Placebo

Generic management plan with non-visual elements

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish College of Optometry and Vision Science

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Danish College of Optometry and Vision Science

Randers, Central Region, Denmark, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Marianne L Maagaard, MSc

Role: CONTACT

+45 22 91 92 01

Ivan Nisted, MPH

Role: CONTACT

+45 30 82 57 64

Facility Contacts

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Marianne Ledet Maagaard, MSc

Role: primary

+45 22919201

Ivan Nisted, MSc

Role: backup

Other Identifiers

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1-10-72-22-21

Identifier Type: -

Identifier Source: org_study_id

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