Study of Refractive Change Induced by 2.8-mm Corneal Incisions for Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Induced corneal refractive change
研究概览
简要总结
The investigators' purpose is to study the induced refractive change caused by different 2.8-mm corneal incision locations in phacoemulsification, because the investigators hypothesize that the effect may be different for nasal, temporal, and superior location, although they are considered astigmatism neutral.
Patients will be randomized to nasal or temporal incision, or assigned to superior incision, depending on preexisting astigmatism. Visual acuity, refraction, keratometry, Pentacam analysis, intraocular pressure, biomicroscopy, and funduscopy, will be carried out before and after phacoemulsification.
Outcome measures will be induced corneal refractive change (Fourier power vector analysis), ISV change, and visual acuity, at 6 months.
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)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Visual impairment for daily tasks caused by cataract
- •Age older than 50 years
- •Steep axis of corneal astigmatism at 90° ± 20° or 180° ± 20°
- •Ability to cooperate in the protocol procedures
排除标准
- •Age below 50
- •Inability to cooperate with measurements
结局指标
主要结局
Induced corneal refractive change
时间窗: 6 months
次要结局
- ISV change(6 months)
- Visual acuity(6 months)