Comparison Between Spectacles and Contact Lenses

Not Applicable

Recruiting

• Conditions: Photophobia

• Registration Number: NCT06905912
• Lead Sponsor: University of Oklahoma

Brief Summary

Many people suffer from migraine headaches, some more so than others and a common trigger/complaint is light sensitivity, or photophobia1. Some will go to great lengths to avoid light: a dark room with sunglasses on and blankets over the windows, often missing work/school/social activities, etc. Several ocular conditions are accompanied by photophobia, ranging from mild to debilitating.

Detailed Description

Burstein et al. describe a shared neuronal pathway between processing light and migraine signals2. Vessels in the dura mater, which are stimulated during migraines, provide input to the Trigeminal Ganglion (TG), which travels to spinal nuclei, which have connections that synapse in the Lateral Posterior Nucleus (LPN). Some intrinsically photosensitive retinal ganglion cells (ipRGC) also synapse through the LPN. The ipRGC are stimulated by light spectra, such as blue light. The crosstalk between the synapses of the ipRGC and pathways from the dura mater vessels causes an overwhelming number of signals that can cause symptoms ranging from cognitive, visual, motor, olfactory, or auditory disfunctions. Thus, it seems reasonable that a reduction in the amount of light stimulation will help alleviate the overload of signals during a migraine, which will decrease the intensity.

FL-41 glasses filter out approximately 50% of blue light and have been shown effective for migraine reduction3. Altius tinted contact lenses filter out 99% of blue light and therefore should be more effective at reducing photophobia. Since the contact lens has direct contact with and coverage of the cornea, no unfiltered stray light is able to enter the eye thus enhancing its efficacy.

Study Timeline

• Study First Submitted: 2024-08-21
• Study Start: 2024-12-10
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-28
• Last Update Submitted: 2025-03-28
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Comparing FL-41 Tinted Eyeglasses, Biomedics 55 Premier, and Altius Grey-Green Tinted Contacts	baseline, after 10 days of wearing Biomedics 22 Premier contacts, and after 10 days of wearing Altius colored contacts.	questionnaires - scale of 1 to 10 - no light sensitivity and 10 extreme light sensitivity

Secondary Outcome Measures

Name	Time	Method
Evaluating FL-41 Tinted Spectacles	immediately after subject finished at least 30 days of wearing the spectacles but before wearing the Biomedics 55 Premier Contacts	questionnaire - scale 1-10 :1-no light sensitivity and 10 extreme light sensitivity
Evaluating Biomedics 55 Premier Contacts	immediately after subject finished 10 days of wearing the Biomedics 55 premier contact lenses but before wearing the Altius tinted Contacts	questionnaire - scale 1-10 :1-no light sensitivity and 10 extreme light sensitivity
Evaluating Altius Grey-Green Tinted Contacts	immediately after subject finished 10 days of wearing the grey-green tinted contact lenses	questionnaire - scale 1-10 :1-no light sensitivity and 10 extreme light sensitivity
Evaluating Altius Amber Tinted Contacts	immediately after subject finished 10 days of wearing the amber tinted contacts	questionnaire - scale 1-10 :1-no light sensitivity and 10 extreme light sensitivity

Trial Locations

Locations (1)

Dean McGee Eye Institute; 🇺🇸 Oklahoma City, Oklahoma, United States