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

D

Danish College of Optometry and Vision Science

Status

Enrolling

Conditions

Concussion, Mild
Convergence Insufficiency

Treatments

Other: Vergence exercises (Orthoptic exercises)
Genetic: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05012384
1-10-72-22-21

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

30 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups, including a placebo group

Vergence exercises
Experimental group
Description:
Orthoptic vergence exercises
Treatment:
Other: Vergence exercises (Orthoptic exercises)
Generic treatment
Placebo Comparator group
Treatment:
Genetic: Placebo

Trial contacts and locations

1

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Central trial contact

Ivan Nisted, MPH; Marianne L Maagaard, MSc

Data sourced from clinicaltrials.gov

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