跳至主要内容
临床试验/CTRI/2022/07/043955
CTRI/2022/07/043955招募中不适用

A sling to prevent Intraocular Lens swing- A prospective interventional study

Hyderabad Eye Research Foundation1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年7月20日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
58
试验地点
1
主要终点
1)Incidence of IOL stability—as documented in Slit lamp

研究概览

简要总结

Among 20 million cataract surgeries being performed worldwide every year approximately 5% are being complicated by Posterior Capsular rent (PCR) and Zonular Dialysis (ZD). The next step in management of these complications is to place the IOL in the sulcus which involves the risk of IOL drop into the vitreous, the most dreadful event for a cataract surgeon when there is no vitreo-retinal backup available. So to reduce this risk, we have described a simple yet effective technique where 10-0 nylon suture will be passed through the dialing hole of a rigid single piece IOL and it will be used as a sling for the safe and centered placement of IOL in the sulcus. We will be doing a prospective interventional study incorporating this technique while performing cataract surgery when it will be complicated by intra-operative PCR or ZD. Post operatively, the patients will be followed up on day 1, week 1, 6 weeks, 3 months and 6 months to access IOL position and BCVA and to look for post operative complications.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
30.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients with intra operative PCR or ZD.

排除标准

  • Intraop PCR/ZD where pupil became smaller than 3mm 2) Cases where ZD is too large >2 quadrants 3) Patients where lens material has dropped into posterior segment 4) Patients where ciliary sulcus support is inadequate.

结局指标

主要结局

1)Incidence of IOL stability—as documented in Slit lamp

时间窗: 3 months

2)Best corrected visual acuity (BCVA)

时间窗: 3 months

次要结局

  • IOL position as documented by Ultrasound Biomicroscopy(6 weeks)

研究者

申办方类型
Research institution

研究点 (1)

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