Outcome With Hydrophobic and Hydrophilic Intraocular Lens in Patients With and Without Uveitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in inflammatory response
研究概览
简要总结
Cataract, is a clouding of the lens in the eye gradually leading to reduction of the visual acuity. In most cases it can be managed with surgery, removing the own lens and replacing it with an artificial lens, intraocular lens (IOL). These lenses are made in different materials with different properties.
Uveitis refers to an inflammation in the iris, ciliary body and choroid. Patients with this disease have an increased risk of developing cataract due to the inflammation itself and treatment with steroids. They also have an increased risk of complications during surgery and postoperatively. In this group the selection of IOL might be of greater importance.
The aim of this prospective randomized controlled study is to compare the outcome of hydrophobic and hydrophilic intraocular lenses in patients with and without uveitis
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
- Single (Participant)
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
- •Cataract requiring surgery
- •Ability to understand and sign consent form
排除标准
- •Extensive corneal scarring
- •Other eye surgery less than 3 months before inclusion
- •Unregulated glaucoma
- •Active uveitis (increased inflammation and treatment less than 3 months before inclusion)
- •Intraoperative complications (capsular tear or vitreous loss)
研究组 & 干预措施
Hydrophobic IOL: Vivinex (HOYA)
Intraocular lens with hydrophobic properties: Vivinex (HOYA).
干预措施: Hydrophobic IOL: Vivinex (HOYA) (Device)
Hydrophilic IOL: INCISE (Bausch+Lomb)
Intraocular lens with hydrophilic properties: INCISE (Bausch+Lomb).
干预措施: Hydrophilic IOL: INCISE (Bausch+Lomb) (Device)
结局指标
主要结局
Change in inflammatory response
时间窗: Preoperatively and at seven occasions within two years postoperatively
次要结局
- Evaluation of posterior capsule opacification after six months(Six months (plus or minus 30 days) postoperatively)
- Evaluation of posterior capsule opacification after one year(One year (plus or minus 30 days) postoperatively)
- Change in best corrected visual acuity assessed in decimal using Snellen charts(Preoperatively and at six occasions within two years postoperatively)
- Complications(Preoperatively and at seven occasions within two years postoperatively)
- Evaluation of posterior capsule opacification after two years(Two years (plus or minus 2 months) postoperatively)