Tixel Treatment for Dry Eye Symptoms

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05299619
• Other study ID #: CLN0683
• Status: Completed
• Phase: N/A
• Start date: March 28, 2019
• Est. completion date: March 28, 2022

Study information

• Verified date: March 2022
• Source: Vallmedic Vision & Aesthetic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 28, 2022
• Est. primary completion date: February 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Peri-orbital Wrinkles

Intervention

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).

Locations

Country	Name	City	State
Andorra	Vallmedic Vision & Aesthetic	Escaldes-Engordany

Sponsors (1)

Lead Sponsor	Collaborator
Dr Ludger Hanneken

Country where clinical trial is conducted

Andorra, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, Device related AE frequency in the study	Any safety related event during the study will be recorded and analysed	8 months
Primary	NIBUT in Seconds	Non-Invasive Break Up Time	8 months
Secondary	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
Secondary	Osmolarity mOsml/L	Osmolarity test with TearLab	8 months
Secondary	Staining; Total Ocular Staining Score	Corneal staining fluorescein and conjunctival/lid margin staining lissamine green	8 month