Use of Tinted Contact Lenses for Concussion-Related Light Sensitivity

The University of Alabama at Birmingham

Status: Not yet enrolling

Conditions: Photophobia; Contact Lens; Concussion, Mild

Treatments: Device: broad band (clear) contact lenses; Device: Narrow band (tinted) contact lenses

Study type: Interventional

Funder types: Other

Identifiers

NCT07223086

IRB-300015049

Faculty development grant (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Participants with concussion and light sensitivity fit with broad band (clear) contact lens

Active Comparator group

Description:

UPSIS-2 scale 15-60, eligible participants score greater than or equal to 26 are fit in broad band (clear) contact lenses.

Treatment:

Device: broad band (clear) contact lenses

Participants with concussion and light sensitivity fit with narrow band (tinted) contact lens

Active Comparator group

Description:

UPSIS-2 scale 15-60, eligible participants score greater than or equal to 26 are fit in narrow wavelength (tinted) contact lenses.

Treatment:

Device: Narrow band (tinted) contact lenses