Patients will be randomised to one of two groups:~Group 1~Patients wear sham glasses for 4 weeks~Patients have 1 week's washout~Patients wear active glasses for 4 weeks~Group 2~Patients wear active glasses for 4 weeks~Patients have 1 week's washout~Patients wear sham glasses for 4 weeks~The study will aim to determine whether wearing the active lens successfully reduces the symptoms of migraine, compared to wearing sham lens.~Assuming a fairly conservative SD in the primary endpoint of 8 points, a total of 56 participants would be required to have 90% power to detect a minimum clinically significant difference of 5 points in a two-sample t-test. Allowing for a 20% drop-out rate, 70 participants would need to be recruited.~Patients will be in the trial for a total of 13 weeks (4 week run-in, two 4 week periods, with 1 week washout in between).
This proof of concept clinical study will investigate the efficacy of active lens with frame in alleviating the symptoms of migraine which are caused by photosensitivity.~The spectacles cut out blue light wavelength and hypothetically alleviate symptoms of migraine and thus either treat or prevent migraine headaches from occurring.