Zero CDE Technique for Lens Nucleus Removal During Femtosecond Laser-Assisted Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- % of cataract cases completed with Zero CDE
研究概览
简要总结
The Zero CDE (cumulative dissipated energy) technique facilitates cataract removal with no or minimal phaco energy. This is facilitated by a femtosecond laser, which pre-divides the cataractous lens nucleus into multiple small segments that can be aspirated without phaco energy being delivered to the eye. In the investigator's experience, this technique consistently shows a stable anterior chamber, a low complication rate, and a rapid return of vision following cataract surgery. This prospective study aims to document the outcomes with the zero CDE technique during femtosecond laser-assisted cataract surgery (FLACS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients over the age of 50 years with operable cataract of nuclear sclerosis grade 1 to 3 as measured by LOCS III grading system (patients with cortical or posterior subcapsular cataract of any grade will be eligible).
- •Patients must be able to provide written informed consent for participating in the study.
- •Preoperative best corrected visual acuity of 20/25 or worse.
排除标准
- •Patients with corneal edema, corneal guttata, pseudoexfoliation, zonular dialysis, or other ocular anomalies (e.g., inflammation, uveitis, previous trauma, suspected microbial infection, glaucoma, and macular disease).
- •Patients wearing soft contact lenses will need to discontinue lens wear for 2 weeks, and hard contact lens wearers for one month prior to intraocular lens measurements.
- •Women patients of childbearing potential.
- •Patients undergoing arcuate keratotomy or other combined surgery with cataract.
研究组 & 干预措施
Cataract removal with Zero CDE technique
This is a single-arm, non-comparative, prospective study including cataract patients with a nuclear sclerosis grade between 1 to 3 who desire to undergo cataract surgery and IOL implantation at Bochner Eye Institute, Canada.
干预措施: Femtosecond laser-assisted cataract surgery using Zero CDE (Procedure)
结局指标
主要结局
% of cataract cases completed with Zero CDE
时间窗: Intraoperative
次要结局
- Among the cataract cases with zero CDE, o the average amount of balanced salt solution (BSS) (ml) used per case.(Intraoperative)
- Among the cataract cases with zero CDE o % of cataract cases with corneal edema at one-day postop.(Postoperative Day 1)
- Among the cataract cases with zero CDE o % of cataract cases with CME at any time up to 3 months postop.(Postoperative 2 weeks, 1 month and 3 months)
- Among the cases requiring CDE, the amount of phaco energy used(Intraoperative)
- Incidence of adverse events(Intraoperative, and postoperative Day 1, 2 weeks, 1 month, and 3 months)
研究者
Raymond Stein
Medical Director
Bochner Eye Institute