Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The percentage of resolved chalazion 4 weeks after the last treatment in the study group and the control group
研究概览
简要总结
To study the effectiveness and safety of IPL treatment for Chalazion
详细描述
The study aims to evaluate the effectiveness and safety of IPL therapy for the treatment of chalazion. The effect of IPL on chalazion will be examined in a masked randomized controlled study. Subjects in the study arm will be treated with IPL, while subjects in the control arm will be treated with sham IPL. A significant difference in the outcomes of the two arms will provide support for a genuine contribution of the IPL treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Subject is able to read, understand, and sign an Informed Consent Form (ICF)
- •18 years of age or older
- •Clinical diagnosis of chalazion in the inflammatory stage
- •Subject is willing to comply with all study procedures-
排除标准
- •Concurrent eyelid infection
- •Chalazion with atypical features, which to the opinion of the study investigator is inadequate for a study
- •Recurring Chalazion
- •Floppy eyelid syndrome
- •Demodex blepharitis patients taking Lotilaner ophthalmic solution within 30 days prior to screening
- •Ocular surgery within 3 months prior to screening
- •Current diagnosis of malignant tumors in the affected eyelid, including:
- •sebaceous carcinoma and basal cell carcinoma
- •Laser Assisted In Situ Keratomileusis (LASIK)/Small Incision Lenticule Extraction (SMILE) surgery, within 1 year prior to screening
- •Radial Keratotomy (RK) surgery
- •Recent ocular trauma, within 3 months prior to screening
- •Pre-cancerous lesions or skin cancer in the planned treatment area
- •Severe active allergies, or other severe uncontrolled eye disorders affecting the ocular surface
- •Uncontrolled infections or uncontrolled immunosuppressive diseases
- •Best corrected visual acuity worse than 20/200 in either eye
- •Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, Epithelial Basement Membrane Dystrophy - EBMD)
- •Within 1 week prior to screening, use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort
- •Active sun burn in the treatment area
- •Anterior chamber inflammation
- •Corneal edema
- •Any condition revealed w
研究组 & 干预措施
study arm
subjects in the study arm will receive active IPL treatment
干预措施: Active IPL (Device)
Control arm
subjects in the control arm will receive sham IPL treatment
干预措施: Sham IPL (Device)
结局指标
主要结局
The percentage of resolved chalazion 4 weeks after the last treatment in the study group and the control group
时间窗: 4 weeks after the last treatment
the proportion of subjects with reduction of at lease 80% in lesion size at the follow up visit
次要结局
- Percentage change from baseline in lesion size in both groups(4 weeks after the last treatment)
- Time to resolution which is defined as a reduction of at least 80% in lesion size in both groups(4 weeks after last treatment)