Spectacles Lens in Concussed Kids

NCT ID: NCT03123822

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-31
• Study Completion Date: 2021-10-01

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.

Conditions

Concussion, Mild; Convergence Insufficiency; Accommodation; Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Single vision glasses

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

Group Type: EXPERIMENTAL

Glasses

Intervention Type: DEVICE

Glasses traditionally prescribed for refractive error

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.

Group Type: EXPERIMENTAL

Glasses

Intervention Type: DEVICE

Glasses traditionally prescribed for refractive error

Eyezen

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

Group Type: EXPERIMENTAL

Glasses

Intervention Type: DEVICE

Glasses traditionally prescribed for refractive error

Interventions

Glasses

Glasses traditionally prescribed for refractive error

Intervention Type: DEVICE

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Katherine K Weise

Director of Pediatric Optometry Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Becky Luu, OD

Role: STUDY_DIRECTOR

University of Alabama at Birmingham

Katherine Weise, OD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama School of Optometry

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2020

Identifier Type: -

Identifier Source: org_study_id