Status:
UNKNOWN
Assessing the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs
Lead Sponsor:
Aston University
Conditions:
Dry Eye
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
Phase:
NA
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
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04730336
Start Date
August 9 2019
End Date
October 31 2023
Last Update
July 21 2023
Active Locations (1)
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1
Midland Eye
Solihull, United Kingdom, B91 2AW