To evaluate the safety and efficacy of Femto capsulotomy flap technique in Femtosecond Laser assisted cataract surgery for Dense cataracts
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- UCVA, BCVA, ECD (endothelial cell density)
研究概览
简要总结
This is a prospective, interventional, non-randomised, single centre, comparative study to evaluate the safety and efficacy (visual outcomes and endothelial cell density) of femto capsulotomy flap technique in femtosecond laser assisted cataract surgery for hard cataracts. 50 eyes fulfilling the inclusion and exclusion criteria undergoing femtosecond laser assisted cataract surgery(FLACS) to be performed by a single surgeon at Nethradhama superspeciality eye hospital will be included in the study. 25 eyes will be included in the FLACS with flap group and 25 eyes will be included in the FLACS only group which will serve as cases and controls, respectively. This technique involves attaching femto capsulotomy flap to the endothelial cell layer using viscoelastic devices to serve as mechanical barrier against ultrasound energy used during emulsification of hard cataracts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Cataract grade NO4NC4 or more (according to LOCS III CLASSIFICATION) undergoing FLACS.
- •Subjects are willing and able to understand and sign an informed consent.
- •Subjects are willing and able to attend postoperative examinations per protocol schedule.
排除标准
- •1.Cataract grade less than NO4 NC4 2.Chronic uveitis 3.Endothelial cell density (ECD) less than 1500 cells/mm2 4.Pupil dilatation less than 6mm 5.Anterior chamber depth (ACD) equals to or less than VH2 6.Concurrent participation in another drug or device study.
结局指标
主要结局
UCVA, BCVA, ECD (endothelial cell density)
时间窗: Time Frame: Pre-operative visit, 1 day, 15, 90, and 180 Days Follow-up
次要结局
- 1. Coefficient of variation of corneal endothelium(2. Corneal clarity (Grading of oedema))