Influence of 2% HPMC Used During Cataract Surgery for Intraoperative Corneal Optical Clarity and Post-operation Xerophthalmia.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change from baseline dry eye condition at 1 month
研究概览
简要总结
This randomized controlled subject- and examiner-masked study comprised patients scheduled for cataract surgery.The patients will be randomly assigned to receive either balanced salt solution（BSS）or hydroxypropyl methylcellulose（HPMC）2% gel （Cornea Protect）.Each subject should undertake examination including - rupture time (TBUT), height of the river of tears, fluorescence staining, Schirmer Ⅰ test, ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire for assessment.
详细描述
This randomized controlled subject- and examiner-masked study comprised patients scheduled for cataract surgery.Over 100 patients will be randomly assigned to receive either balanced salt solution（BSS）or hydroxypropyl methylcellulose（HPMC）2% gel （Cornea Protect）.Each subject will accept 5 times assessments:the day before surgery, surgery day , the day after surgery,a week after surgery and a month after surgery.Each time a subject should undertake examination including - rupture time (TBUT), height of the river of tears, fluorescence staining, Schirmer Ⅰ test, ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire et.al.The purpose is to evaluate the effect of Cornea Protect to maintain intraoperative clarity and to prevent the postoperative xerophthalmia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •with cataracts;
- •aged 40 to 85 years old, gender not limited;
- •plans to accept PHACO and intraocular lens(IOL)implantation surgery
- •the lens nucleus hardness level is less than 3 ;
- •signed informed consent.
排除标准
- •allergic to any of the drugs or device in this study ；
- •existence of other infectious diseases or allergic conjunctivitis.
- •the eye had been chemical burned or thermal burned
- •diagnosed as Stevens Johnson syndrome or eye-pemphigoid.
- •diagnosed with glaucoma or high intraocular pressure;
- •existence of eyelid and lacrimal duct disease;
- •received any eye surgery in 3 months;
- •wearing corneal contact lens;
- •history suggests there are serious heart, lung, liver or renal function disorder;
- •pregnancy or lactation women;
- •Other conditions considered not appropriate by the investigators.
结局指标
主要结局
change from baseline dry eye condition at 1 month
时间窗: an expected average of a month after the surgery
Dry eye condition includes tear break up time (TBUT), height of the river of tears,Schirmer Ⅰ test,ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire.
Intraoperative corneal clarity
时间窗: during the surgery
record the times of using HPMC or BSS during the surgery to maintain the intraoperative corneal clarity and how long it lasts.
change from baseline corneal damage at 1 month
时间窗: an expected average of a month after the surgery
Corneal damage evaluated by fluorescence staining of cornea
次要结局
- change from baseline dry eye condition at 1 week(an expected average of a week after the surgery)
- Inflammation(an expected average of a month after the surgery)
研究者
Wangshu Yu
Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University