Spectacles Lens in Concussed Kids

Not Applicable

Terminated

• Conditions: Convergence Insufficiency; Accommodation; Insufficiency; Concussion, Mild
• Interventions: Device: Glasses

• Registration Number: NCT03123822
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-21
• Study Start: 2017-10-31
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Results First Submitted: 2021-11-22
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-27
• Last Update Submitted: 2022-05-27
• Results First Posted: 2022-06-23
• Last Update Posted: 2022-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single vision glasses with anti-glare coating	Glasses	Typical glasses prescribed for children to correct only distance prescription with anti-glare coating and to be worn all waking hours.
Eyezen	Glasses	Commercially available, low-powered, progressive addition lenses glasses with anti-glare coating to be worn all waking hours
Single vision glasses	Glasses	Typical glasses prescribed for children to correct only distance refractive error and to be worn all waking hours.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Alabama School of Optometry; 🇺🇸 Birmingham, Alabama, United States