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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03123822
Other study ID # 2020
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 31, 2017
Est. completion date October 1, 2021

Study information

Verified date May 2022
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date October 1, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 17 Years
Eligibility 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 Design


Intervention

Device:
Glasses
Glasses traditionally prescribed for refractive error

Locations

Country Name City State
United States University of Alabama School of Optometry Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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