TerminatedNot Applicable

Spectacles Lens in Concussed Kids

Stopped: Not enough interest/participants. Recruitment was more difficult due to pandemic

United States10 participantsStarted 2017-10-31

Plain-language 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.

Who can participate

Age range9 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Convergence Insufficiency Symptom Survey

Timeframe: Assessed up to 12 months

Trial details

NCT IDNCT03123822

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-01

Results submitted2021-11-22

View on ClinicalTrials.gov More Concussion, Mild trials