Assessing the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs

Aston University

Status

Enrolling

Conditions

Dry Eye

Dry Eye Syndromes

Treatments

Device: Tixel

Study type

Interventional

Funder types

Other

Identifiers

NCT04730336

UREC 1524

Details and patient eligibility

About

Pilot study where effect of standard Tixel treatment as used for periorbital wrinkles would be assessed on Dry Eye Disease symptoms and signs

Full 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

Enrollment

75 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.