NCT03123822

Spectacles Lens in Concussed Kids

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.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 9 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Concussion, Mild
• Convergence Insufficiency
• Accommodation; Insufficiency

Interventions

Type	Name	Description
DEVICE	Glasses	Glasses traditionally prescribed for refractive error

Timeline

• Start date: 2017-10-31
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2017-04-21
• Last updated: 2022-06-23
• Results posted: 2022-06-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study