Efficacy and Safety of Ultrapulse Carbon Dioxide Laser Treatment in Eyelid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Clearance rate
研究概览
简要总结
This study aims to assess the long-term efficacy and safety of ultrapulse carbon dioxide (CO₂) laser excision in the treatment of eyelid tumors, including xanthelasma, pigmented nevi, keratoses, and so on.
详细描述
-Background: The assessment of the efficacy and safety of Ultrapulse CO₂ laser in treating eyelid lesions is crucial for clinical applications. This study aims to evaluate the effectiveness of super-pulsed CO₂ laser in treating different types of eyelid lesions, particularly marginal and large lesions, to provide comprehensive clinical guidance and decision support.
-Main Objectives: A retrospective analysis of the efficacy and safety of Ultrapulse CO₂ laser treatment for various types of eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on.
-Study Design: This study will include 1000 patients diagnosed with eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on. All patients undergoing Ultrapulse CO₂ laser treatment. The evaluation will focus on the efficacy and safety of Ultrapulse CO₂ laser treatment for different types of eyelid lesions.
-Study Population and Anticipated Enrollment: Patients with eyelid lesions (n=1000)
-Inclusion Criteria: Clinically diagnosed with eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on.
- •No history of photosensitivity, bleeding, or coagulation disorders
- •Willing to attend follow-up appointments as scheduled
排除标准
- •Presence of infection in the target area
- •Allergy to lidocaine
- •Keloid-prone or poor skin repair ability
- •Pregnant or lactating
- •Recent history of severe infectious diseases, active skin diseases, or major diseases affecting the cardiovascular, liver, kidney, endocrine, and hematopoietic systems
- •History of malignant tumors or immune system disorders
结局指标
主要结局
Clearance rate
时间窗: 12 months
The lesion clearance rate was classified as the proportion of the lesion cleared (\<50%; 50-75%; 76-99%; or \>99%).
Recurrence rate
时间窗: 12 months
Recurrence was defined as the regrowth of a new xanthelasma lesion within the previously excised area.
次要结局
- Patient satisfaction score(12 months)
- Investigator's Global Assessment (IGA) score(12 months)
- Number of treatment sessions(12 months)
- Postoperative complications(12 months)
研究者
Yingfeng Zheng
Principal Investigator
Sun Yat-sen University