Clinical trial NCT05299619: Tixel Treatment for Dry Eye Symptoms
Official title: A Prospective Study Assessing the Impact of Tixel Treatment of Peri-orbital Wrinkles on Dry Eye Symptoms and Signs in Patients With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-orbital Wrinkles
Dry Eye
Lead sponsor: Vallmedic Vision & Aesthetic
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-center, prospective, non-masked, pilot study, to assess the safety and efficacy of the Tixel treatment.
Primary purpose: TREATMENT

Brief summary: Dry eye syndrome is caused by a chronic lack of sufficient lubrication and moisture on the surface of the eye. Consequences of dry eyes range from subtle but constant eye irritation to significant inflammation and even scarring of the front surface of the eye. Meibomian Gland Dysfunction (MGD) refers to the condition where the glands are not secreting enough oil or when the oil they secrete is of poor quality.

Tixel is a fractional skin rejuvenation system, which relies on direct thermal energy delivery, free of any radiation type such as laser, RF, etc. The energy is transferred via a continuously sterile, thermal titanium element (the "Tip"), located on the applicator (the "Handpiece"). In this study, the principal investigator will undertake standard treatment of periorbital wrinkles with Tixel and observe the effect on dry eye disease symptoms and signs.

Detailed description: Tixel® (Novoxel®, Israel) is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling fast water evaporation with low thermal damage to the surrounding tissue (such as charring or ablation). The system consists of a handpiece connected to a console. The handpiece applies a therapeutic element, the "tip", fixated on the distal section. The tip is comprised of a gold-plated copper base and a thin-walled titanium alloy cover.

While treating patients for wrinkles, it has been observed that in several cases, treatment had an effect on subjects who have been suffering from a pre-condition of dry eye disease. The effect was expressed mainly by increased tearing.

In this study, the principal investigator will undertake standard treatment of periorbital wrinkles with Tixel and observe the effect on dry eye disease symptoms and signs.

Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years
2. Mild to Moderate Periorbital wrinkles
3. OSDI score of at least 23
4. Noninvasive Tear film break up time (NIKBUT) ≤ 10 seconds
5. Willing and able to provide written informed consent.
6. Willing to participate in all study activities and instructions.

Exclusion Criteria:

1. Pregnancy and breastfeeding
2. Lesions in the periorbital area
3. Acute severe blepharitis
4. Acute conjunctivitis
5. Other concomitant anterior eye disease

Primary outcomes:
measure: Safety, Device related AE frequency in the study
timeFrame: 8 months
measure: NIBUT in Seconds
timeFrame: 8 months
Secondary outcomes:
measure: Efficacy assessment - OSDI-Ocular Surface Disease Index Questionnaire changes from baseline
timeFrame: 8 months
measure: Osmolarity mOsml/L
timeFrame: 8 months
measure: Staining; Total Ocular Staining Score
timeFrame: 8 month
Other outcomes:
Locations:
city: Escaldes-Engordany
country: Andorra
facility: Vallmedic Vision & Aesthetic
Study officials:
References: