Tixel Treatment for Dry Eye Symptoms

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Peri-orbital Wrinkles
• Intervention / Treatment: Device: Tixel

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Andorra
  • Escaldes-Engordany, Andorra
    • Vallmedic Vision & Aesthetic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tixel Group; Tixel treatments in Dry Eye Patients	Device: Tixel; 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).; Other Names: thermomechanical system

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osmolarity mOsml/L	Osmolarity test with TearLab	8 months
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
Staining; Total Ocular Staining Score	Corneal staining fluorescein and conjunctival/lid margin staining lissamine green	8 month

Collaborators and Investigators

• Sponsor: Dr Ludger Hanneken

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Actual): February 22, 2022
• Study Completion (Actual): March 28, 2022

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: CLN0683

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No