Single-center, Prospective, Open Label, with Before-After Study Design, to evaluate the safety and efficacy of the optical system in the treatment of dry eye disease.
Single-center, Prospective, Open Label, with Before-After Study Design. Up to 15 subjects will be enrolled in the study to provide at least 10 evaluable subjects. All subjects will undergo 3 treatments two weeks apart (2 weeks (+/-3 days) from the previous treatment). Follow-up visits after the last treatment visit: 4 weeks (±7 days), 12 weeks (±7 days).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
non-invasive light pulse generated by a non-contacting device for the treatment of the symptoms of dry eyes and MDG
Haemek Medical Center
Afula, Israel
RECRUITING4 weeks TBUT change from baseline
Change from baseline to the 4-week follow-up exam in Tear Break Up Times (TBUT), as assessed by a rater.
Time frame: up to 4 weeks post last treatment
OSDI changes from baseline to 4 and 12 weeks FU
Change from baseline in patient symptoms using Ocular Surface Disease Index (OSDI) at 4-weeks and 12-weeks follow-up exam.
Time frame: up to 12 weeks post last treatment
12 weeks TBUT change from baseline
Changes from baseline to the 12-week follow-up exam in Tear Break Up Times (TBUT), as assessed by a rater.
Time frame: 12 weeks post last treatment
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