Pilot study where effect of standard Tixel treatment as used for periorbital wrinkles would be assessed on Dry Eye Disease symptoms and signs
Safety Assessment will be asses via AE/SAE reporting and Impact Assessment of the effect of treatment on dry eye symptoms and signs through multiple test indicate Dry Eye
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Peri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms
Midland Eye
Solihull, United Kingdom
RECRUITINGNIBUT in Seconds
Non-Invasive Break Up Time
Time frame: 18 Weeks
Ocular Surface Disease Index questionnaire
Total 12 questions will be asked, ranked between 0-100. 0 being no dry eye symptoms and 100 severe dry eye symptoms.
Time frame: 18 Weeks
SAFETY, number of AEs
Any safety related event during the study will be recorded and analyzed
Time frame: 18 Weeks
Topography mm D
Topography with K readings
Time frame: 18 Weeks
Slit Lamp Exam; Normal, Abnormal
Multiple Slit Lamp tests
Time frame: 18 Weeks
Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire
Assessment of the frequency and severity of dry eye symptoms. scored 0 to 28; 0 being no dry eye symptoms and 28 severe dry eye symptoms.
Time frame: 18 Weeks
Lid margin profile
Lid margin profile
Time frame: 18 Weeks
Tear Sampling Analysis
ocular tear biomarkers
Time frame: 18 Weeks
Staining; Total Ocular Staining Score
Corneal staining fluorescein and conjunctival/lid margin staining lissamine green
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Time frame: 18 Weeks