NCT04730336招募中不适用
Assessment of the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs in Patients With Dry Eye
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Ocular Surface Disease Index questionnaire
研究概览
简要总结
Pilot study where effect of standard Tixel treatment as used for periorbital wrinkles would be assessed on Dry Eye Disease symptoms and signs
详细描述
Safety Assessment will be asses via AE/SAE reporting and Impact Assessment of the effect of treatment on dry eye symptoms and signs through multiple test indicate Dry Eye
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
- •Age ≥ 18 years
- •Mild to Moderate Periorbital wrinkles
- •OSDI score of at least 23
- •Noninvasive Tear film break up time (NIKBUT) ≤ 10 seconds
- •No other eye or skin or immune problems
- •Willing and able to provide written informed consent.
- •Willing to participate in all study activities and instructions.
排除标准
- •Pregnancy and/or breastfeeding
- •Lesions in the periorbital area
- •Acute severe blepharitis
- •Acute conjunctivitis
- •Other concomitant anterior eye disease
- •Has undergone outdoors/sunbed tanning during the last 4 weeks
- •Is unwilling to follow the Tixel aftercare instructions after each of the three Tixel treatments.
- •Active Herpes Simplex or tendency for Herpes Simplex in the periorbital area (meaning the subject has had the condition previously).
- •Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.
- •An impaired immune system condition or use of immunosuppressive medication.
- •Collagen disorders, keloid formation and/or abnormal wound healing.
- •Previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans for such treatment during the course of the Tixel2 device treatment, or before complete healing of such treatments has occurred.
- •Any patient who takes or has taken any medications (including via topical application), herbal treatment (oral or topic), food supplements or vitamins, which may cause fragile skin or impaired skin healing during the last 3 months.
- •Any patient who has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment or less.
- •Any patient who has a history of bleeding coagulopathies or use of anticoagulants.
- •Any patient who has tattoos or permanent makeup in the treated area.
- •Any patient who has burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated.
- •Any patient who underwent thread lifting of the area to be treated in the last 3 months.
结局指标
主要结局
Ocular Surface Disease Index questionnaire
时间窗: 18 Weeks
Total 12 questions will be asked, ranked between 0-100. 0 being no dry eye symptoms and 100 severe dry eye symptoms.
NIBUT in Seconds
时间窗: 18 Weeks
Non-Invasive Break Up Time
SAFETY, number of AEs
时间窗: 18 Weeks
Any safety related event during the study will be recorded and analyzed
次要结局
- Tear Sampling Analysis(18 Weeks)
- Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire(18 Weeks)
- Lid margin profile(18 Weeks)
- Staining; Total Ocular Staining Score(18 Weeks)
- Topography mm D(18 Weeks)
- Slit Lamp Exam; Normal, Abnormal(18 Weeks)
研究者
研究点 (2)
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