Prospective Randomized Evaluation of Centration of Intraocular Lens With Two Laser Settings for Capsulorhexis With Femtosecond Laser
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Overlap of the Continuous Curvilinear Capsulorhexis margin over the IOL
研究概览
简要总结
The study compares anatomic outcomes of Intra Ocular Lens(IOL) placement with two methods of centration of the capsulorhexis- scanned capsule centration and pupil centration. It is hypothesized that scanned capsule centration provides more uniform(25% better) overlap of capsulorhexis margin over IOL optic compared to pupil centration.
详细描述
50 consecutive eyes undergoing cataract surgery will be studied. 25 eyes will have scanned capsule centration and 25 will have pupil centration. Retroillumination slitlamp photographs will be taken 10-30 days after surgery with dilated pupils. The amount of capsule overlapping the IOL will be documented. The horizontal, vertical and symmetricity of overlap will be calculated.
Each group will have 20 eyes with an additional 5 eyes in each group to account for drop outs or poor quality images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with cataracts
- •Same variety of IOL inserted in all eyes
排除标准
- •Previous glaucoma or retinal surgery
- •Pupil not dilating beyond 6mm
- •Zonular weakness or pseudoexfoliation
- •Extensive corneal scarring
- •High refractive error: Myopia greater than 10D, Hyperopia greater than 5D
结局指标
主要结局
Overlap of the Continuous Curvilinear Capsulorhexis margin over the IOL
时间窗: 10-30 days post surgery
The horizontal and vertical overlap will be calculated. Horizontal overlap= Overlap of the temporal half versus the nasal half Vertical overlap= overlap of the superior half versus the inferior half of the IOL. Symmetricity of overlap= Horizontal overlap/vertical overlap
次要结局
未报告次要终点
研究者
Surendra Basti
Associate Professor of Ophthalmology
Northwestern University