Concussion, Mild Clinical Trial
— SLICKOfficial 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.
NCT number | NCT03123822 |
Other study ID # | 2020 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | October 31, 2017 |
Est. completion date | October 1, 2021 |
Verified date | May 2022 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 10 |
Est. completion date | October 1, 2021 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Years to 17 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama School of Optometry | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Assessed up to 12 months | |
Secondary | 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. | Assessed up to 12 months |
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