Effect of Low-Level Light Therapy Prior to Cataract Surgery: A Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Development or worsening of ocular surface abnormalities: bulbar redness
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of Low Level Light Therapy (LLLT) in reducing the incidence or alleviating the severity of DED due to meibomian gland dysfunction in otherwise healthy patients undergoing cataract surgery.
Participants will be randomly assigned in a 1:1 ratio to either a treatment group or a control group.
The treatment group will receive LLLT one week before and one week after cataract surgery; the control group will not recieve LLLT at any time.
Researchers will compare the treatment and the control group to see if patients receiving LLLT present with reduced signs and symptoms of ocular surface dysfunction with respect to the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •healthy patients affected by senile cataract
- •patients scheduled for phacoemulsification and intraocular lens implantation
排除标准
- •any other ocular comorbidity (e.g. glaucoma),
- •chronic instillation of eye drops of any type
- •previous ocular surgery or trauma to the addressed eye
- •previous cataract surgery in the controlateral eye,
- •active ocular infections
- •use of systemic drug with a known or suspected link to dry eye (e.g. diuretics, antidepressants, antihistamines, hormone replacement therapy)
- •autoimmune diseases (e.g. Sjögren syndrome)
- •intraoperative complications (e.g. capsular bag rupture requiring vitrectomy, suprachoroidal hemorrhage)
- •postoperative complications (e.g. endophthalmitis, vitritis)
结局指标
主要结局
Development or worsening of ocular surface abnormalities: bulbar redness
时间窗: One month (±7 days) after cataract surgery
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). This parameter is expressed as as a ratio of vessels/free sclera and is automatically calculated by the instrument.
Development or worsening of ocular surface abnormalities: meibomian gland dropout
时间窗: One month (±7 days) after cataract surgery
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Dropout is calculated according to the JENVIS meibo scale. Grade 0= no dropout; grade 1= area of gland loss up to 33% of the total gland area; grade 2 = area of gland loss between 33 and 66%; grade 3 = area of gland loss of 67% or more.
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) FIRST
时间窗: One month (±7 days) after cataract surgery
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). NIKBUT FIRST: interval time between the last complete blinking and the first distortion the 22 concentric rings reflected on the corneal surface. Measurement expressed in seconds.
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) CLASS
时间窗: One month (±7 days) after cataract surgery
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). NIKBUT CLASS: classification incorporated in the instrument: class 0 \> 10 s (normal), class I 6 - 10 s, class II 3 - 6 s, class III \< 3 s.Measurement expressed in seconds.
Development or worsening of ocular surface abnormalities: tear meniscus height
时间窗: One month (±7 days) after cataract surgery
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Measurement expressed in millimeters.
Development or worsening of ocular discomfort symptoms.
时间窗: One month (±7 days) after cataract surgery
Evaluation based on the ocular surface disease index (OSDI) questionnaire. Normal OSDI: 0-12; a score of 13 or more is suggestive of dry eye disease (DED) Mild DED = 13 - 22; Moderate DED = 23-32; Severe DED \> 32
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) AVG
时间窗: One month (±7 days) after cataract surgery
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). NIKBUT AVG: average time of all tear film break-ups occurring in the measured period of up to 24.98 seconds (time limit set by the device's software). Measurement expressed in seconds.
次要结局
未报告次要终点
研究者
Giuseppe Giannaccare
Professor
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro