Spectacles Lens in Concussed Kids (SLICK)

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.

Study Overview

• Status: Terminated
• Conditions: Concussion, Mild; Convergence Insufficiency; Accommodation; Insufficiency
• Intervention / Treatment: Device: Glasses

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama School of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single vision glasses; Typical glasses prescribed for children to correct only distance refractive error and to be worn all waking hours.	Device: Glasses; Glasses traditionally prescribed for refractive error
Experimental: Single vision glasses with anti-glare coating; Typical glasses prescribed for children to correct only distance prescription with anti-glare coating and to be worn all waking hours.	Device: Glasses; Glasses traditionally prescribed for refractive error
Experimental: Eyezen; Commercially available, low-powered, progressive addition lenses glasses with anti-glare coating to be worn all waking hours	Device: Glasses; Glasses traditionally prescribed for refractive error

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Study Director: Becky Luu, OD, University of Alabama at Birmingham; Principal Investigator: Katherine Weise, OD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2017
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Cranial Nerve Diseases; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Ocular Motility Disorders
• Other Study ID Numbers: 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes