Tixel treatment for periorbital wrinkles and its effects on dry eye symptoms

Assessment of the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs in Patients With Dry Eye

This study tests if Tixel treatment, which helps reduce wrinkles around the eyes, can also improve dry eye symptoms for people who suffer from them.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aston University (Academic / other)
• Locations: 1 site (Solihull)
• Trial ID: NCT04730336 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the impact of Tixel treatment, typically used for reducing periorbital wrinkles, on symptoms and signs of Dry Eye Disease. Participants will undergo Tixel treatment, and the study will assess both the safety of the procedure and its effectiveness in alleviating dry eye symptoms through various assessments. The study aims to determine if improving the appearance of the skin around the eyes can also enhance tear film stability and overall eye comfort.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with mild to moderate periorbital wrinkles and specific dry eye symptoms.

Not a fit: Patients with severe eye conditions, active infections, or those who have undergone recent skin treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a dual benefit of reducing wrinkles while also alleviating dry eye symptoms.

How similar studies have performed: While this approach is relatively novel, similar studies exploring the effects of cosmetic treatments on eye symptoms have shown promising results.

Eligibility criteria

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.

Where this trial is running

Solihull

• Midland Eye — Solihull, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Sunil Shah, Phd — Midland Eye
• Study coordinator: Sunil Shah, Phd

Conditions Dry Eye; Dry Eye Syndromes