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Spectacles Lens in Concussed Kids (SLICK)

Primary Purpose

Concussion, Mild, Convergence Insufficiency, Accommodation; Insufficiency

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glasses
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Concussion, Mild

Eligibility Criteria

9 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama School of Optometry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Single vision glasses

Single vision glasses with anti-glare coating

Eyezen

Arm Description

Typical glasses prescribed for children to correct only distance refractive error and to be worn all waking hours.

Typical glasses prescribed for children to correct only distance prescription with anti-glare coating and to be worn all waking hours.

Commercially available, low-powered, progressive addition lenses glasses with anti-glare coating to be worn all waking hours

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 13, 2017
Last Updated
May 27, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03123822
Brief Title
Spectacles Lens in Concussed Kids
Acronym
SLICK
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Not enough interest/participants. Recruitment was more difficult due to pandemic
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild, Convergence Insufficiency, Accommodation; Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single vision glasses
Arm Type
Experimental
Arm Description
Typical glasses prescribed for children to correct only distance refractive error and to be worn all waking hours.
Arm Title
Single vision glasses with anti-glare coating
Arm Type
Experimental
Arm Description
Typical glasses prescribed for children to correct only distance prescription with anti-glare coating and to be worn all waking hours.
Arm Title
Eyezen
Arm Type
Experimental
Arm Description
Commercially available, low-powered, progressive addition lenses glasses with anti-glare coating to be worn all waking hours
Intervention Type
Device
Intervention Name(s)
Glasses
Intervention Description
Glasses traditionally prescribed for refractive error
Primary Outcome Measure Information:
Title
Convergence Insufficiency Symptom Survey
Description
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.
Time Frame
Assessed up to 12 months
Secondary Outcome Measure Information:
Title
Convergence Breaking Point at Near (Base Out Prism)
Description
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.
Time Frame
Assessed up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Becky Luu, OD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Katherine Weise, OD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama School of Optometry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Spectacles Lens in Concussed Kids

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