Cataract Surgery in Patients With Pseudoexfoliation and Pseudoexfoliation Glaucoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- IOP Change
研究概览
简要总结
The study aims to document the effect cataract surgery has on the pseudoexfoliation and pseudoexfoliation glaucoma eye. Details such has patient history, history of possible glaucoma, intraocular pressure, status of the eye, operation parameters and postoperative effect will be documented. The study is prospective and randomised . Patients will be divided in to two groups: in one standard phacoemulsification cataract surgery will be preformed. In the second group the anterior chamber angel will be aspirated an extra minute at the end of the case with the IA probe. The aim is to determine weather this extra aspiration will have an effect on postoperative intraocular pressure and other parameters.
详细描述
This randomized clinical trial will be performed at the Helsinki University Central Hospital. Patients that are eligible for cataract surgery will be recruited. A history of pseudoexfoliation or pseudoexfoliation glaucoma is required.
Preoperative data such as age, sex, ethnicity, history of diabetes and history of high blood are recorded. If the participant has pseudoexfoliation glaucoma the following data will be recorded: number of years elapsed since the diagnosis; number of glaucoma medications; number of active agents; possible bilateral disease.
Visual acuity is attained during every visit (preoperatively and 1 day, 1 week, 1 month, 6 months, 1 year, 2 years and 3 years postoperatively) using the Snellen chart. Both uncorrected and best corrected visual acuity are attained.
Intraocular pressure (IOP) is also attained during every visit using the Goldmann applanation tonometer (measured twice during each visit). The measurements will be taken between 8 a.m and 12 p.m to minimize the effect of diurnal fluctuations.
Biomicroscopy will be done preoperatively to assess the following: conjunctival hyperemia; possible pseudoxfoliation material on the endothelium, iris border and lens capsule; anterior chamber angle opening (grade 0-4 using the Shaffer system); existence of the Sampaolesi line; iris dilatation in millimeters (20 minutes after instilling 1 drop of tropicamid 5mg/ml and 1 drop of 2,5% phenylephrine; nuclear sclerosis (grades 0-4); presence of phacodonesis.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The patient will not know which group he or she has been randomised to during the duration of the study. The care provider and investigator will not know the randomisation before the patient is enrolled in the study. The care provider and investigator will know the randomisation group at the time of randomisation, which will take place after the preoperative data collection.
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
- •The patient has to meet the criteria set by the Helsinki Central University hospital for cataract surgery: best corrected visual acuity of 0,5 (Snellen) or below in the better eye or 0,3 (Snellen) or below in the worse eye; glare or other debilitating symptoms determined to be caused by cataract; cataract interfering with the diagnosis or follow up of glaucoma
- •Pseudoexfoliation or pseudoexfoliation glaucoma
排除标准
- •Previous intraocular surgery of any kind
- •Previous glaucoma surgery or cyclophotocoagulation
- •Previous selective laser trabeculoplasty (SLT) or argon laser trabeculoplasty (ALT)
- •Any other ocular pathology likely to demand surgery during the course of the study
- •Wet age related macular degeneration (wetAMD)
- •Need for glaucoma surgery determined by a glaucoma specialist in cases where the intraocular pressure is deemed to high compared to the ocular nerve head condition and/or visual field defect.
- •History of uveitis.
- •History of herpetic keratitis.
- •History of ocular trauma.
- •Dementia or other conditions preventing the patient from adhering to the study protocol.
结局指标
主要结局
IOP Change
时间窗: IOP will be measured preoperatively and at 1 day, 1 week, 1 month, 6 months, 1 year, 2 years and 3 years postoperatively.
Intraocular pressure (IOP) measured twice during every visit with a Goldmann applanation. tonometer. Measurements will be taken before 12 p.m local time. Change from baseline is being measured at these specified times.
次要结局
- Visual acuity change(Preoperative and at 1 day, 1 week, 1 month, 6 months, 1 year, 2 years and 3 years postoperatively.)
研究者
Peeter Kuddu
Principal Investigator
Helsinki University Central Hospital