Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- French version of Ocular Surface Disease Index (OSDI) score
研究概览
简要总结
Laser corneal refractive surgery is a widely adopted approach for correcting refractive errors, but postoperative dry eye remains a common side effect. Intense Pulsed Light (IPL) and Low-Level Light Therapy (LLLT) are two emerging treatments that have shown potential in managing dry eye disease. However, their role as a prophylactic treatment in patients without pre-existing symptomatic dry eye undergoing refractive surgery has not been explored.
详细描述
monocentric, randomized, simple bling, controlled study
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 (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients eligible for laser corneal refractive surgery (FS-LASIK, SMILE®, or PRK) who meet the inclusion criteria will be enrolled.
排除标准
- •include age < 18 and contraindications to IPL or LLLT (e.g., pregnancy, lactation, migraine, epilepsy, palpebral or periocular lesion, photosensitive drugs, cardiac pacing system or implantable cardiovertor defibrillator, Fitzpatrick phototypes V and VI).
研究组 & 干预措施
treatment
preventive treatment by IPL+LLLT with EYE-LIGHT, Espansione group
干预措施: IPL+LLLT (Device)
standard
non preventive treatment by IPL+LLLT with EYE-LIGHT, Espansione group = standard care
结局指标
主要结局
French version of Ocular Surface Disease Index (OSDI) score
时间窗: 1 month post-operative
The OSDI questionnaire measures frequency of symptoms, environmental triggers and vision related quality of life. OSDI values range from 0 to 100. A score between 13 and 22 excluded indicates a medium intensity eye dryness. A score between 22 and 33 indicated a moderate intensity eye dryness. A score above 33 indicates a severe eye dryness.
次要结局
- Evolution of Fluorescein Break-up Time (FBUT) over the 6 first months post-operative(6 months post-operative)
- Evolution of Schirmer I test over the 6 first months post-operative(6 months post-operative)
- Evolution of Meibomian Gland Dropout over the 6 first months post-operative(6 months post-operative)
- Evolution of the Oxford score over the 6 first months post-operative(6 months post-operative)
- Evolution of the French version of Ocular Surface Disease Index (OSDI) score over the 6 first months post-operative(6 months post-operative)
- Evolution of visual acuity over the 6 first months post-operative(6 months post-operative)