Assessing the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs
- Conditions
- Dry EyeDry Eye Syndromes
- Interventions
- Device: Tixel
- Registration Number
- NCT04730336
- Lead Sponsor
- Aston University
- Brief Summary
Pilot study where effect of standard Tixel treatment as used for periorbital wrinkles would be assessed on Dry Eye Disease symptoms and signs
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- Age ≥ 18 years
- Mild to Moderate Periorbital wrinkles
- OSDI score of at least 23
- Noninvasive Tear film break up time (NIKBUT) ≤ 10 seconds
- No other eye or skin or immune problems
- Willing and able to provide written informed consent.
- Willing to participate in all study activities and instructions.
- Pregnancy and/or breastfeeding
- Lesions in the periorbital area
- Acute severe blepharitis
- Acute conjunctivitis
- Other concomitant anterior eye disease
- Has undergone outdoors/sunbed tanning during the last 4 weeks
- Is unwilling to follow the Tixel aftercare instructions after each of the three Tixel treatments.
- Active Herpes Simplex or tendency for Herpes Simplex in the periorbital area (meaning the subject has had the condition previously).
- Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.
- An impaired immune system condition or use of immunosuppressive medication.
- Collagen disorders, keloid formation and/or abnormal wound healing.
- Previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans for such treatment during the course of the Tixel2 device treatment, or before complete healing of such treatments has occurred.
- Any patient who takes or has taken any medications (including via topical application), herbal treatment (oral or topic), food supplements or vitamins, which may cause fragile skin or impaired skin healing during the last 3 months.
- Any patient who has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment or less.
- Any patient who has a history of bleeding coagulopathies or use of anticoagulants.
- Any patient who has tattoos or permanent makeup in the treated area.
- Any patient who has burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated.
- Any patient who underwent thread lifting of the area to be treated in the last 3 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tixel Treatment Tixel Tixel Treatment 3 Tixel treatment sessions, 2 weeks apart follow by 2 Follow up sessions
- Primary Outcome Measures
Name Time Method Ocular Surface Disease Index questionnaire 18 Weeks Total 12 questions will be asked, ranked between 0-100. 0 being no dry eye symptoms and 100 severe dry eye symptoms.
NIBUT in Seconds 18 Weeks Non-Invasive Break Up Time
SAFETY, number of AEs 18 Weeks Any safety related event during the study will be recorded and analyzed
- Secondary Outcome Measures
Name Time Method Tear Sampling Analysis 18 Weeks ocular tear biomarkers
Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire 18 Weeks 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.
Lid margin profile 18 Weeks Lid margin profile
Staining; Total Ocular Staining Score 18 Weeks Corneal staining fluorescein and conjunctival/lid margin staining lissamine green
Topography mm D 18 Weeks Topography with K readings
Slit Lamp Exam; Normal, Abnormal 18 Weeks Multiple Slit Lamp tests
Trial Locations
- Locations (1)
Midland Eye
🇬🇧Solihull, United Kingdom