Dry Eye, Peri-orbital Wrinkles
Conditions
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.
Interventions
DEVICETixel
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).
Sponsors
Dr Ludger Hanneken
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A single-center, prospective, non-masked, pilot study, to assess the safety and efficacy of the Tixel treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety, Device related AE frequency in the study | 8 months | Any safety related event during the study will be recorded and analysed |
| NIBUT in Seconds | 8 months | Non-Invasive Break Up Time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Osmolarity mOsml/L | 8 months | Osmolarity test with TearLab |
| Staining; Total Ocular Staining Score | 8 month | Corneal staining fluorescein and conjunctival/lid margin staining lissamine green |
Countries
Andorra
Outcome results
None listed