Tixel Treatment for Dry Eye Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Study Assessing the Impact of Tixel Treatment of Peri-orbital Wrinkles on Dry Eye Symptoms and Signs in Patients With Dry Eye

Conditions
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Peri-orbital Wrinkles, Dry Eye

Intervention / Treatment
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* Device: Tixel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years Mild to Moderate Periorbital wrinkles OSDI score of at least 23 Noninvasive Tear film break up time (NIKBUT) ≤ 10 seconds Willing and able to provide written informed consent. Willing to participate in all study activities and instructions. Exclusion Criteria: Pregnancy and breastfeeding Lesions in the periorbital area Acute severe blepharitis Acute conjunctivitis Other concomitant anterior eye disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A single-center, prospective, non-masked, pilot study, to assess the safety and efficacy of the Tixel treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tixel Group<br>Tixel treatments in Dry Eye Patients | Device: Tixel<br>* 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).<br>* Other names: thermomechanical system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, Device related AE frequency in the study | Any safety related event during the study will be recorded and analysed | 8 months | 
| NIBUT in Seconds | Non-Invasive Break Up Time | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy assessment - OSDI-Ocular Surface Disease Index Questionnaire changes from baseline | OSDI Score; 12 Questions; answers between 0-4; Total score calculated 0-100. Higher score means worst Dry Eye Symptomes | 8 months | 
| Osmolarity mOsml/L | Osmolarity test with TearLab | 8 months | 
| Staining; Total Ocular Staining Score | Corneal staining fluorescein and conjunctival/lid margin staining lissamine green | 8 month |