Tixel Treatment for Dry Eye Symptoms

NCT ID: NCT05299619

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-28
• Study Completion Date: 2022-03-28

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.

Conditions

Peri-orbital Wrinkles; Dry Eye

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tixel Group

Tixel treatments in Dry Eye Patients

Group Type: EXPERIMENTAL

Tixel

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

thermomechanical system

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr Ludger Hanneken

OTHER

Sponsor Role: lead

Responsible Party

Dr Ludger Hanneken

Principle investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Vallmedic Vision & Aesthetic

Les Escaldes, , Andorra

Countries

Andorra

Other Identifiers

CLN0683

Identifier Type: -

Identifier Source: org_study_id