Tixel Treatment for Dry Eye Symptoms

Not Applicable

Completed

• Conditions: Dry Eye; Peri-orbital Wrinkles
• Interventions: Device: Tixel

• Registration Number: NCT05299619
• Lead Sponsor: Dr Ludger Hanneken

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.

Study Timeline

• Study Start: 2019-03-28
• Study First Submitted: 2021-12-21
• Primary Completion: 2022-02-22
• Status Verified: 2022-03
• Study Completion: 2022-03-28
• Study First Submitted QC: 2022-03-28
• Last Update Submitted: 2022-03-28
• Study First Posted: 2022-03-29
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tixel Group	Tixel	Tixel treatments in Dry Eye Patients

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vallmedic Vision & Aesthetic; 🇦🇩 Escaldes-Engordany, Andorra