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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)

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123822


Contacts
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Contact: Becky Luu, OD 205-996-2319 luu.becky@gmail.com
Contact: Katherine Weise, OD kweise@uab.edu

Locations
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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
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Study Director: Becky Luu, OD University of Alabama at Birmingham
Principal Investigator: Katherine Weise, OD University of Alabama at Birmingham
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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    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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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