Status:
RECRUITING
Comparison Between Spectacles and Contact Lenses
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
Dean A. McGee Eye Institute
Conditions:
Photophobia
Eligibility:
All Genders
18+ years
Phase:
NA
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 wit...
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 Gan...
Eligibility Criteria
Inclusion
- Two hundred voluntary subjects will be recruited by researching those who have purchased FL-41 tinted spectacles from the Dean McGee Eye Institute Optical Department. If this does not recruit enough subjects then subject referrals will be solicited from the patient population of the Dean McGee Eye Institute and/or neurology clinics throughout the Oklahoma City metro area.
- Subjects must meet the following criteria in order to participate in this study:
- Subjects must have worn FL-41 tinted spectacles for at least one month prior to participating in this study.
- Subjects must have at least 20/30 distance visual acuity in each eye while wearing the contact lenses. Altius lenses are currently available in spherical powers from plano to -6.00.
- Subjects must demonstrate the ability to insert and remove contact lenses. Assistance from friends and family is acceptable.
- Subjects must not have an infectious or progressive ocular disease.
- Subjects not meeting all of the above criteria will be excluded from participating in this study.
- Early Termination:
- If a subject feels their photophobia increases to an intolerable level, they can stop wearing that contact lens type and switch to the other the next day or terminate participation in the study. If this occurs, the data from those subjects will still be included in the study data analysis.
- If a subject or physician feel that the health of their cornea is at risk, the subject will cease wearing all contact lenses and seek medical care from the Dean McGee Eye Institute.
- \-
Exclusion
Key Trial Info
Start Date :
December 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06905912
Start Date
December 10 2024
End Date
September 1 2025
Last Update
April 2 2025
Active Locations (1)
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1
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104