Tixel Treatment for Dry Eye Symptoms

Sponsor
Dr Ludger Hanneken (Other)
Overall Status
Completed
CT.gov ID
NCT05299619
Collaborator
(none)
40
1
1
36
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Tixel
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A single-center, prospective, non-masked, pilot study, to assess the safety and efficacy of the Tixel treatment.A single-center, prospective, non-masked, pilot study, to assess the safety and efficacy of the Tixel treatment.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 28, 2019
Actual Primary Completion Date :
Feb 22, 2022
Actual Study Completion Date :
Mar 28, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Safety, Device related AE frequency in the study [8 months]

      Any safety related event during the study will be recorded and analysed

    2. NIBUT in Seconds [8 months]

      Non-Invasive Break Up Time

    Secondary Outcome Measures

    1. 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

    2. Osmolarity mOsml/L [8 months]

      Osmolarity test with TearLab

    3. Staining; Total Ocular Staining Score [8 month]

      Corneal staining fluorescein and conjunctival/lid margin staining lissamine green

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vallmedic Vision & Aesthetic Escaldes-Engordany Andorra

    Sponsors and Collaborators

    • Dr Ludger Hanneken

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Ludger Hanneken, Principle investigator, Vallmedic Vision & Aesthetic
    ClinicalTrials.gov Identifier:
    NCT05299619
    Other Study ID Numbers:
    • CLN0683
    First Posted:
    Mar 29, 2022
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 29, 2022