Wound Architecture and Functional Outcome After Cataract Surgery With Manual vs. Femtosecond Laser Assisted Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,123
- 试验地点
- 2
- 主要终点
- Preservation of a physiological postoperative anatomy will be considered as a criterion of success
研究概览
简要总结
This study is the long term analysis of two types of FSL 3-plane corneal wound profiles, namely CT1 and CT2 obtained after a FSL cataract surgery.
详细描述
Femtosecond laser cataract surgery offers several major advantages for wound construction, including high precision, repeatability and a large variety of corneal wound profiles. The aim of this study is the long term analysis of two types of FSL 3-plane corneal wound profiles, namely CT1 and CT2, CT2 being constructed with a reversed front corneal incision segment to ensure tigher wound closure and better corneal wound reapposition. The traditional manual wound performed with a standard keratome will be used as a reference. As FSL cataract surgery may be associated with a greater incidence of wound leaks at the end of surgery as compared to manual wound construction with keratomes, this study will also aim at determining wich clinical and OCT wound parameters are associated with a higher likelihood of wound leaks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Consecutive patients who underwent cataract surgery using one of the following three types of surgical wound will be compared:
- Catalys - Initial wound parameters
- Catalys - Revised wound parameters
- Standard manual technique (MT control group)
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
- •Consecutive cases of cataract surgery performed between January 2015 and june 2015 by a single surgeon (PH) at the clinique d'ophtalmologie Bellevue, using either the Catalys or a manual technique.
- •One eye per patient, the first eye
- •Uneventful cataract only
排除标准
- •Combined glaucoma filtering surgery
- •Any previous corneal surgery in this eye
- •Any pathology of the interior segment
- •Inflammatory eye disease of the interior segment
结局指标
主要结局
Preservation of a physiological postoperative anatomy will be considered as a criterion of success
时间窗: 2 Months
Change in corneal anatomy as measured by the difference between pre-and postoperative corneal profile on OCT images
次要结局
- The absence or a lower incidence of wound leak will also be considered as a criterion of success(2 Months)
研究者
Dr. Paul Harasymowycz
Chief of Glaucoma Service University of Montreal
Maisonneuve-Rosemont Hospital