A Prospective Study Assessing the Impact of Tixel Treatment of Peri-orbital Wrinkles on Dry Eye Symptoms and Signs in Patients With Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety, Device related AE frequency in the study
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pregnancy and breastfeeding
- •Lesions in the periorbital area
- •Acute severe blepharitis
- •Acute conjunctivitis
- •Other concomitant anterior eye disease
结局指标
主要结局
Safety, Device related AE frequency in the study
时间窗: 8 months
Any safety related event during the study will be recorded and analysed
NIBUT in Seconds
时间窗: 8 months
Non-Invasive Break Up Time
次要结局
- Efficacy assessment - OSDI-Ocular Surface Disease Index Questionnaire changes from baseline(8 months)
- Osmolarity mOsml/L(8 months)
- Staining; Total Ocular Staining Score(8 month)
研究者
Dr Ludger Hanneken
Principle investigator
Vallmedic Vision & Aesthetic