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. (SLICK)

• ClinicalTrials.gov Identifier: NCT03123822
• Recruitment Status: Recruiting
• First Posted: April 21, 2017
• Last Update Posted: July 16, 2020
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Katherine K Weise, University of Alabama at Birmingham

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Concussion, Mild; Convergence Insufficiency; Accommodation; Insufficiency	Device: Glasses	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Spectacles Lens in Concussed Kids
• Actual Study Start Date: January 26, 2018
• Estimated Primary Completion Date: January 2022
• Estimated Study Completion Date: January 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Convergence Insufficiency Symptom Survey [ Time Frame: Assessed up to 12 months ]
   This survey quantifies convergence insufficiency symptoms on a scale and has been proven to be an effective and accurate gauge by previous research and study groups.

Secondary Outcome Measures :

1. Objective binocular vision findings [ Time Frame: Assessed up to 12 months ]
   Standard of care assessment of binocular vision function

Eligibility Criteria

• Ages Eligible for Study: 9 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Becky Luu, OD; 205-996-2319; luu.becky@gmail.com

Contact: Katherine Weise, OD; kweise@uab.edu

Locations

United States, Alabama

University of Alabama School of Optometry; Recruiting

Birmingham, Alabama, United States, 35233

Contact: Katherine Weise, OD kweise@uab.edu

Contact: Becky Luu, OD luu.becky@gmail.com

Sponsors and Collaborators

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

More Information

• Responsible Party: Katherine K Weise, Director of Pediatric Optometry Services, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03123822
• Other Study ID Numbers: 2020
• First Posted: April 21, 2017
• Last Update Posted: July 16, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Additional relevant MeSH terms:

Brain Concussion; Ocular Motility Disorders; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Cranial Nerve Diseases; Eye Diseases