Clinical trial NCT03123822: Spectacles Lens in Concussed Kids
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Concussion, Mild
Convergence Insufficiency
Accommodation; Insufficiency
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 10
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Convergence Insufficiency Symptom Survey
timeFrame: Assessed up to 12 months
Secondary outcomes:
measure: Convergence Breaking Point at Near (Base Out Prism)
timeFrame: Assessed up to 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama School of Optometry
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Becky Luu, OD
role: STUDY_DIRECTOR
affiliation: University of Alabama at Birmingham
name: Katherine Weise, OD
role: PRINCIPAL_INVESTIGATOR
References: