Concussion, MildNCT05012384
Effect of Vergence Exercises for Patients With Convergence Insufficiency After Concussion.
A study testing Vergence exercises (Orthoptic exercises) in people with Concussion, Mild and Convergence Insufficiency, run by Danish College of Optometry and Vision Science at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Concussion, Mild, Convergence Insufficiency
- What is being tested?
- Vergence exercises (Orthoptic exercises)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2021to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Concussion at least 3 month ago
- Convergence insufficiency which has not been diagnosed prior to the concussion
Who cannot join
- Patient who are unable to fulfill baseline examination
- Manifest or paralytic strabismus
- Self-reported eye disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Danish College of Optometry and Vision Science
Randers, Central Region, Denmark, 8960
Marianne Ledet Maagaard, MSc, +45 22919201, mlm@eadania.dk
Ivan Nisted, MSc, 30825764, ivn@eadania.dk
About this study
Official title: 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.
Read more
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
- Being tested
- Vergence exercises (Orthoptic exercises), Placebo
- Medical subject headings
- Brain Concussion, Ocular Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vergence exercises (Orthoptic exercises)Other
Vergence exercises as described by the Convergence Insufficiency Treatment Trials Group (CITT)
PlaceboGenetic
Generic management plan with non-visual elements
| Study group | Role | What they receive |
|---|---|---|
| Vergence exercises | Experimental | Orthoptic vergence exercises Receives: Other: Vergence exercises (Orthoptic exercises) |
| Generic treatment | Placebo comparator | Not described Receives: Genetic: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Convergence Insufficiency Symptom Survey (CISS) week 18
Questionnaire assessing the frequency of eye and visually related symptom during near work
Measured: 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
Measured: Duration (5 minutes) and performed at week 36
Near point of convergence - week 18
Psychophysical test of the eyes ability to converge
Measured: Duration (2 minutes) and performed at week 18
Near point of convergence - week 36
Psychophysical test of the eyes ability to converge
Measured: Duration (2 minutes) and performed at week 36
Positive fusional vergence at 40 cm - week 18
Psychophysical test of the slow fusional adaptation
Measured: Duration (2 minutes) and performed at week 18
Positive fusional vergence at 40 cm - week 36
Psychophysical test of the slow fusional adaptation
Measured: Duration (2 minutes) and performed at week 36
Vergence facility at 40 cm - week 18
Psychophysical test of fast fusional adaptation
Measured: Duration (2 minutes) and performed at week 18
Vergence facility at 40 cm - week 36
Psychophysical test of fast fusional adaptation
Measured: Duration (2 minutes) and performed at week 36
Secondary outcomes (2)
Rivermead post-concussional symptoms questionnaire (RPQ) - week 18
Questionnaire assessing the frequency of symptoms during activities of daily living
Measured: 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
Measured: Duration (5 minutes) and performed at week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Jul 2021
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish College of Optometry and Vision Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012384
- Sponsor's protocol ID
- 1-10-72-22-21
- Status last verified
- Sep 2023
- First submitted
- 8 Jul 2021
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vergence Exercises for Rehabilitation of Patients With Convergence Insufficiency as a Long-term Consequence of Concussion.
- ClinicalTrials.gov ID
- NCT05012384
- Acronym / sponsor ID
- 1-10-72-22-21
- Conditions
- Concussion, Mild, Convergence Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Danish College of Optometry and Vision ScienceUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Vergence exercises | Experimental | Other: Vergence exercises (Orthoptic exercises)Orthoptic vergence exercises |
| Generic treatment | Placebo comparator | Genetic: Placebo |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Concussion at least 3 month ago
- Convergence insufficiency which has not been diagnosed prior to the concussion
Key exclusion criteria (3 listed)
- Patient who are unable to fulfill baseline examination
- Manifest or paralytic strabismus
- Self-reported eye disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vergence exercises (Orthoptic exercises)Vergence exercises as described by the Convergence Insufficiency Treatment Trials Group (CITT) | Other | Vergence exercises |
| PlaceboGeneric management plan with non-visual elements | Genetic | Generic treatment |
Primary outcome
Convergence Insufficiency Symptom Survey (CISS) week 18
Time frame: Duration (5 minutes) and performed at week 18
Questionnaire assessing the frequency of eye and visually related symptom during near work
Convergence Insufficiency Symptom Survey (CISS) week 36
Time frame: Duration (5 minutes) and performed at week 36
Questionnaire assessing the frequency of eye and visually related symptom during near work
Near point of convergence - week 18
Time frame: Duration (2 minutes) and performed at week 18
Psychophysical test of the eyes ability to converge
Near point of convergence - week 36
Time frame: Duration (2 minutes) and performed at week 36
Psychophysical test of the eyes ability to converge
Positive fusional vergence at 40 cm - week 18
Time frame: Duration (2 minutes) and performed at week 18
Psychophysical test of the slow fusional adaptation
Positive fusional vergence at 40 cm - week 36
Time frame: Duration (2 minutes) and performed at week 36
Psychophysical test of the slow fusional adaptation
Vergence facility at 40 cm - week 18
Time frame: Duration (2 minutes) and performed at week 18
Psychophysical test of fast fusional adaptation
Vergence facility at 40 cm - week 36
Time frame: Duration (2 minutes) and performed at week 36
Psychophysical test of fast fusional adaptation
2 secondary outcomes
Rivermead post-concussional symptoms questionnaire (RPQ) - week 18
Time frame: Duration (5 minutes) and performed at week 18
Rivermead post-concussional symptoms questionnaire (RPQ) - week 36
Time frame: Duration (5 minutes) and performed at week 36
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vergence exercises (Orthoptic exercises) in people with Concussion, Mild and Convergence Insufficiency, run by Danish College of Optometry and Vision Science at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marianne L Maagaard, MSc (+45 22 91 92 01, mlm@eadania.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Convergence Insufficiency Symptom Survey (CISS) week 18 (time frame: Duration (5 minutes) and performed at week 18). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.