Status:

COMPLETED

Tixel Treatment for Dry Eye Symptoms

Lead Sponsor:

Dr Ludger Hanneken

Conditions:

Peri-orbital Wrinkles

Dry Eye

Eligibility:

All Genders

18+ years

Phase:

NA

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 inf...

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 eva...

Eligibility Criteria

Inclusion

  • ≥ 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

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

Key Trial Info

Start Date :

March 28 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 28 2022

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT05299619

Start Date

March 28 2019

End Date

March 28 2022

Last Update

March 29 2022

Active Locations (1)

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1

Vallmedic Vision & Aesthetic

Les Escaldes, Andorra