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Completed

NCT Number: NCT05299619

Tixel Treatment for Dry Eye Symptoms

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.

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Key information

Conditions

Peri-orbital Wrinkles Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vallmedic Vision & Aesthetic

Les Escaldes, Andorra

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years
  • Mild to Moderate Periorbital wrinkles
  • OSDI score of at least 23
  • Noninvasive Tear film break up time (NIKBUT) ≤ 10 seconds
  • Willing and able to provide written informed consent.
  • Willing to participate in all study activities and instructions.

Exclusion criteria

  • Pregnancy and breastfeeding
  • Lesions in the periorbital area
  • Acute severe blepharitis
  • Acute conjunctivitis
  • Other concomitant anterior eye disease

Treatment and study plan

Tixel

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).

Other names: thermomechanical system

Primary outcomes

  1. Safety, Device related AE frequency in the study

    Time frame: 8 months

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

  2. NIBUT in Seconds

    Time frame: 8 months

    Non-Invasive Break Up Time

Secondary outcomes

  1. Efficacy assessment - OSDI-Ocular Surface Disease Index Questionnaire changes from baseline

    Time frame: 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

    Time frame: 8 months

    Osmolarity test with TearLab

  3. Staining; Total Ocular Staining Score

    Time frame: 8 month

    Corneal staining fluorescein and conjunctival/lid margin staining lissamine green

Sponsors and collaborators

Lead sponsor

Dr Ludger Hanneken

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 29, 2022
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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