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 range

9 Years – 17 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

9 Years – 17 Years

Sex

ALL

See this in plain English?

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