SLICK: Spectacles Lens in Concussed Kids

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03123822
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 3
• Actual Duration (Months): 47
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Concussion, Mild; Convergence Insufficiency; Accommodation; Insufficiency	Device: Glasses	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Oct 31, 2017
• Actual Primary Completion Date: Oct 1, 2021
• Actual Study Completion Date: Oct 1, 2021

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 [Assessed up to 12 months]

   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

1. Convergence Breaking Point at Near (Base Out Prism) [Assessed up to 12 months]

   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.

Eligibility Criteria

Criteria

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

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama School of Optometry	Birmingham	Alabama	United States	35233

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

Study Documents (Full-Text)

• Study Protocol - Apr 2, 2022

More Information

Publications

None provided.

• 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: Apr 21, 2017
• Last Update Posted: Jun 23, 2022
• Last Verified: May 1, 2022

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

Study Results

Participant Flow

Arm/Group Title	Single Vision Glasses	Single Vision Glasses With Anti-glare Coating	Eyezen
Arm/Group Description	Typical glasses prescribed for children to correct only distance refractive error and to be worn all waking hours. Glasses: Glasses traditionally prescribed for refractive error	Typical glasses prescribed for children to correct only distance prescription with anti-glare coating and to be worn all waking hours. Glasses: Glasses traditionally prescribed for refractive error	Commercially available, low-powered, progressive addition lenses glasses with anti-glare coating to be worn all waking hours Glasses: Glasses traditionally prescribed for refractive error
Period Title: Overall Study
STARTED	1	1	3
COMPLETED	1	1	3
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Single Vision Glasses	Single Vision Glasses With Anti-glare Coating	Eyezen	Total
Arm/Group Description	Typical glasses prescribed for children to correct only distance refractive error and to be worn all waking hours. Glasses: Glasses traditionally prescribed for refractive error	Typical glasses prescribed for children to correct only distance prescription with anti-glare coating and to be worn all waking hours. Glasses: Glasses traditionally prescribed for refractive error	Commercially available, low-powered, progressive addition lenses glasses with anti-glare coating to be worn all waking hours Glasses: Glasses traditionally prescribed for refractive error	Total of all reporting groups
Overall Participants	1	1	3	5
Age (Count of Participants)
<=18 years	1 100%	1 100%	3 100%	5 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	17	14	16	16
Sex: Female, Male (Count of Participants)
Female	1 100%	1 100%	2 66.7%	4 80%
Male	0 0%	0 0%	1 33.3%	1 20%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants met the criteria of the study

Arm/Group Title	Single Vision Glasses	Single Vision Glasses With Anti-glare Coating	Eyezen
Arm/Group Description	Typical glasses prescribed for children to correct only distance refractive error and to be worn all waking hours. Glasses: Glasses traditionally prescribed for refractive error	Typical glasses prescribed for children to correct only distance prescription with anti-glare coating and to be worn all waking hours. Glasses: Glasses traditionally prescribed for refractive error	Commercially available, low-powered, progressive addition lenses glasses with anti-glare coating to be worn all waking hours Glasses: Glasses traditionally prescribed for refractive error
Measure Participants	1	1	1
Mean (Standard Deviation) [score on a scale]	29 (0)	22 (0)	14 (0)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants meet inclusion criteria. However, 2 of the 5 participants did not return for the follow up visit and therefore do not have outcome measurements.

Arm/Group Title	Single Vision Glasses	Single Vision Glasses With Anti-glare Coating	Eyezen
Arm/Group Description	Typical glasses prescribed for children to correct only distance refractive error and to be worn all waking hours. Glasses: Glasses traditionally prescribed for refractive error	Typical glasses prescribed for children to correct only distance prescription with anti-glare coating and to be worn all waking hours. Glasses: Glasses traditionally prescribed for refractive error	Commercially available, low-powered, progressive addition lenses glasses with anti-glare coating to be worn all waking hours Glasses: Glasses traditionally prescribed for refractive error
Measure Participants	1	1	1
Mean (Standard Deviation) [prism diopters]	16 (0)	40 (0)	12 (0)

Adverse Events

Time Frame	Each participant was enrolled for roughly 3 months and was able to keep the glasses after that period.
Adverse Event Reporting Description	The definitions did not differ.
Arm/Group Title	Single Vision Glasses		Single Vision Glasses With Anti-glare Coating		Eyezen
Arm/Group Description	Typical glasses prescribed for children to correct only distance refractive error and to be worn all waking hours. Glasses: Glasses traditionally prescribed for refractive error		Typical glasses prescribed for children to correct only distance prescription with anti-glare coating and to be worn all waking hours. Glasses: Glasses traditionally prescribed for refractive error		Commercially available, low-powered, progressive addition lenses glasses with anti-glare coating to be worn all waking hours Glasses: Glasses traditionally prescribed for refractive error
All Cause Mortality
	Single Vision Glasses		Single Vision Glasses With Anti-glare Coating		Eyezen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)		0/3 (0%)
Serious Adverse Events
	Single Vision Glasses		Single Vision Glasses With Anti-glare Coating		Eyezen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Single Vision Glasses		Single Vision Glasses With Anti-glare Coating		Eyezen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.