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Recruiting NCT07223086

Use of Tinted Contact Lenses for Concussion-Related Light Sensitivity

No phase Interventional Concussion, Mild Photophobia Contact Lens

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Narrow band (tinted) contact lenses, broad band (clear) contact lenses.
Who it may be relevant to
Registry conditions: Concussion, Mild, Photophobia, Contact Lens. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The purpose of this study is to gather pilot data on the effectiveness of daily disposable tinted contact lenses in reducing photophobia (light sensitivity) following a concussion, with the goal of facilitating the return to work or school.

Interventions

  • Device Narrow band (tinted) contact lenses
    Participants will receive these contacts based on the results of the Utah Photophobia Symptom Impact Scale (survey).
  • Device broad band (clear) contact lenses
    Participants will receive these contacts based on the results of the Utah Photophobia Symptom Impact Scale (survey).

Primary outcome measures

  • Number of participants that improved symptoms of light sensitivity with narrow band (tinted) contact lenses [Time frame: Baseline, 1 week]

Eligibility criteria

Inclusion criteria

  • diagnosed mild traumatic brain injury (concussion)
  • age 18 or older
  • Within 24 months of initial injury
  • experiencing symptoms of photophobia (light sensitivity), increased photophobia since the injury, or no symptoms of photophobia

Exclusion criteria

  • moderate or severe concussion
  • active infection or inflammation that contradicts the use of soft contact lenses
  • subjects unable to safely perform insertion and removal of the contact lenses

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • UAB Eye Care — Birmingham

Identifiers

NCT: NCT07223086 · IRB-300015049 · Faculty development grant

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗