Spectacles Lens in Concussed Kids

NCT03123822 | Terminated Results FDA Device

• 1 other identifier: 2020
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Mild; Convergence Insufficiency; Accommodation; Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Convergence Breaking Point at Near (Base Out Prism)

  Assessed up to 12 months

Study Arms (3)

Single vision glasses

EXPERIMENTAL

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

Device: Glasses

Single vision glasses with anti-glare coating

EXPERIMENTAL

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

Device: Glasses

Eyezen

EXPERIMENTAL

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

Device: Glasses

Interventions

Glasses DEVICE

Glasses traditionally prescribed for refractive error

Eyezen; Single vision glasses; Single vision glasses with anti-glare coating

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama School of Optometry

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Brain Concussion; Ocular Motility Disorders

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Cranial Nerve Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Katherine Weise
• Organization: UAB

kweise@uab.edu

2059752020

Study Officials

• Becky Luu, OD

  University of Alabama at Birmingham

  STUDY DIRECTOR

• Katherine Weise, OD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pediatric Optometry Services

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 21, 2017
• Study Start: October 31, 2017
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: June 23, 2022
• Results First Posted: June 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)