Concussion, MildSLICKNCT03123822
Spectacles Lens in Concussed Kids
A study testing Glasses in people with Concussion, Mild and Convergence Insufficiency, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
We will be looking at 3 treatment arms in the form of different type of glasses to see if one is superior to helping kids have sustained a concussion and are symptomatic. Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Mild, Convergence Insufficiency, Accommodation; Insufficiency
- What is being tested?
- Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2017to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 9 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Sustained a concussion > 6 weeks < 16 weeks from date of initial visit
- Criteria for concussion: formally diagnosed by physician
- Minimum best corrected visual acuity: 20/25 in right and left eyes at distance and 20/30 both eyes at near
- Minimum Stereopsis: 500" global
- CISS score > 16
- Refractive error at least + 0.50D sphere or cylinder
- Ability to clear > 0.50 cycles per minute in monocular accommodative flipper of and binocular accommodative flipper of +/-1.50
Who cannot join
- Diplopia from nerve palsies
- Retinal pathology
- Previous treatment of any amount of bifocal lenses and base in prism since concussion.
- Vision therapy > 6 weeks since concussion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama School of Optometry
Birmingham, Alabama, 35233
About this study
Official title: To Compare the Effectiveness of 3 Different Types of Lens and Lens Coating in Eliminating Symptoms for Children With Prolonged Visual Symptoms Due to a Concussion.
We will be looking at 3 treatment arms in the form of different type of glasses to see if one is superior to helping kids have sustained a concussion and are symptomatic.
Read the detailed description
Recent studies have shown children who sustain a concussion are susceptible to having chronic symptoms (post-concussion syndrome). This chronicity can lead to delays in returning to learn and returning to play. Blurry vision, double vision, eye strain and eye tracking problems are some of the reported chronic symptoms that can affect patients' daily activities. Concussion awareness has increased recently and there is a surge of interest to better understand and treat the symptoms of post-concussion syndrome. Currently, ocular treatment for patients are often empirically determined. Common treatments are vision therapy and/or bifocal glasses. There has yet to be any standardization or prospective studies looking into treatment for these concussed patients with ocular symptoms and findings. The objective of this protocol is to compare three different types of glasses (typical prescription glasses for kids, typical glasses for kids with anti-glare coating, and progressive addition lenses with anti-glare coating) as treatment options for participants who are still symptomatic four weeks out from their concussion. The main outcome is the effectiveness of these three different options in reducing patients' symptoms and improving the participants' visual findings.
- Being tested
- Glasses
- 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.
GlassesDevice
Glasses traditionally prescribed for refractive error
| Study group | Role | What they receive |
|---|---|---|
| Single vision glasses | Experimental | Typical glasses prescribed for children to correct only distance refractive error and to be worn all waking hours. Receives: Device: Glasses |
| Single vision glasses with anti-glare coating | Experimental | Typical glasses prescribed for children to correct only distance prescription with anti-glare coating and to be worn all waking hours. Receives: Device: Glasses |
| Eyezen | Experimental | Commercially available, low-powered, progressive addition lenses glasses with anti-glare coating to be worn all waking hours Receives: Device: Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Convergence Insufficiency Symptom Survey
This survey quantifies convergence insufficiency symptoms on a scale. The scale measures the severity of symptoms from the condition, convergence insufficiency. Score on a scale can range from 0 (least) to 60 (worst). This survey has been proven to be an effective and accurate gauge by previous research and study groups.
Measured: Assessed up to 12 months
Secondary outcomes (1)
Convergence Breaking Point at Near (Base Out Prism)
This outcome measurement was the maximum base out prism diopters when the patient first reported diplopia of a near target or started suppressing one of the eyes as determined by the examiner.
Measured: Assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start31 Oct 2017
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Why it stopped: Not enough interest/participants. Recruitment was more difficult due to pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine K Weise, University of Alabama at Birmingham
- Investigators
- Becky Luu, OD, Study director, University of Alabama at BirminghamKatherine Weise, OD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123822
- Sponsor's protocol ID
- 2020
- Acronym
- SLICK
- Status last verified
- May 2022
- First submitted
- 13 Apr 2017
- Last updated
- 23 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Effectiveness of 3 Different Types of Lens and Lens Coating in Eliminating Symptoms for Children With Prolonged Visual Symptoms Due to a Concussion.
- ClinicalTrials.gov ID
- NCT03123822
- Acronym / sponsor ID
- SLICK / 2020
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough interest/participants. Recruitment was more difficult due to pandemic
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Posted 23 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will be looking at 3 treatment arms in the form of different type of glasses to see if one is superior to helping kids have sustained a concussion and are symptomatic.
Detailed description
Recent studies have shown children who sustain a concussion are susceptible to having chronic symptoms (post-concussion syndrome). This chronicity can lead to delays in returning to learn and returning to play. Blurry vision, double vision, eye strain and eye tracking problems are some of the reported chronic symptoms that can affect patients' daily activities. Concussion awareness has increased recently and there is a surge of interest to better understand and treat the symptoms of post-concussion syndrome. Currently, ocular treatment for patients are often empirically determined. Common treatments are vision therapy and/or bifocal glasses. There has yet to be any standardization or prospective studies looking into treatment for these concussed patients with ocular symptoms and findings. The objective of this protocol is to compare three different types of glasses (typical prescription glasses for kids, typical glasses for kids with anti-glare coating, and progressive addition lenses with anti-glare coating) as treatment options for participants who are still symptomatic four weeks out from their concussion. The main outcome is the effectiveness of these three different options in reducing patients' symptoms and improving the participants' visual findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single vision glasses | Experimental | Device: GlassesTypical glasses prescribed for children to correct only distance refractive error and to be worn all waking hours. |
| Single vision glasses with anti-glare coating | Experimental | Device: GlassesTypical glasses prescribed for children to correct only distance prescription with anti-glare coating and to be worn all waking hours. |
| Eyezen | Experimental | Device: GlassesCommercially available, low-powered, progressive addition lenses glasses with anti-glare coating to be worn all waking hours |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Sustained a concussion > 6 weeks < 16 weeks from date of initial visit
- Criteria for concussion: formally diagnosed by physician
- Minimum best corrected visual acuity: 20/25 in right and left eyes at distance and 20/30 both eyes at near
- Minimum Stereopsis: 500" global
- CISS score > 16
Key exclusion criteria (4 listed)
- Diplopia from nerve palsies
- Retinal pathology
- Previous treatment of any amount of bifocal lenses and base in prism since concussion.
- Vision therapy > 6 weeks since concussion
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 |
|---|---|---|
| GlassesGlasses traditionally prescribed for refractive error | Device | Eyezen, Single vision glasses, Single vision glasses with anti-glare coating |
Primary outcome
Convergence Insufficiency Symptom Survey
Time frame: Assessed up to 12 months
This survey quantifies convergence insufficiency symptoms on a scale. The scale measures the severity of symptoms from the condition, convergence insufficiency. Score on a scale can range from 0 (least) to 60 (worst). This survey has been proven to be an effective and accurate gauge by previous research and study groups.
1 secondary outcome
Convergence Breaking Point at Near (Base Out Prism)
Time frame: Assessed up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Becky Luu, OD study director
University of Alabama at Birmingham
Katherine Weise, OD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glasses in people with Concussion, Mild and Convergence Insufficiency, run by University of Alabama at Birmingham at 1 site in United States.
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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 23 Jun 2022. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 23 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Convergence Insufficiency Symptom Survey (time frame: Assessed up to 12 months). 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 23 Jun 2022.