跳至主要内容
临床试验/CTRI/2020/10/028742
CTRI/2020/10/028742尚未招募不适用

Comparative study of four standard techniques of nucleus management in brunescent cataract during Phacoemulsification

Sankara Eye Hospital Guntur1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年10月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
1. To record in all the four nucleotomy techniques, the intraoperative parameters such as

研究概览

简要总结

Performing Phacoemulsification in brown cataracts has many challenges with a high complication rate even in experienced hands. In brunescent cataract, the hard, unyielding leathery fibres of the lens nucleus poses a great difficulty to perform phacoemulsification. Hence many variations in the nucleotomy techniques is also being practiced with an aim to achieve an uneventful and safe outcome.

Thus use of safer phaco techniques that will significantly reduce the phaco time and energy and consequential corneal endothelial cell loss can be more rewarding for both the patient and surgeon because of profound restoration of vision and a successful outcome.             Hence this study is undertaken, to compare the four nucleotomy techniques (Divide and Conquer, Stop and Chop, Horizontal Chop and Vertical Chop) in terms of its intraoperative paratemeters like (phaco time and phaco energy), the corneal endothelial parameters (cell density, coefficient of variation and central corneal thickness) and visual acuity.

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
50.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with brunescent cataract.
  • (nuclear opalascence (NO) grade 6 according to LOCS III classification) 2.Patients belonging to age group >50 years.

排除标准

  • 1.Specular microscopy counts less than 2000 cells/mm2 2.Small pupil (less than 3mm) 3.Pseudoexfoliation 4.Shallow anterior chamber depth (less than one fourth the corneal thickness), as according to Van Herick’s grading of peripheral anterior chamber depth.
  • 5.Corneal disorders like corneal opacity, degenerations and dystrophies.
  • 6.Subluxated/traumatic cataract 7.Ocular inflammation 8.Coexisting retinal pathologies or undergone previous retinal surgeries.

结局指标

主要结局

1. To record in all the four nucleotomy techniques, the intraoperative parameters such as

时间窗: On the day of presentation and follow up at 1 week and 1 month postoperatively

a)Mean phaco time (min)

时间窗: On the day of presentation and follow up at 1 week and 1 month postoperatively

b)Mean phaco power (%)

时间窗: On the day of presentation and follow up at 1 week and 1 month postoperatively

c)Effective Phaco Time (EPT)

时间窗: On the day of presentation and follow up at 1 week and 1 month postoperatively

2. To compare the endothelial parameters like cell density, Coefficient of variation (CV) and central corneal thickness (CCT) before and after the surgery in each of these techniques.

时间窗: On the day of presentation and follow up at 1 week and 1 month postoperatively

次要结局

  • To record visual acuity(On the day of presentation and at 1 week and 1 month postoperatively)

研究者

发起方
Sankara Eye Hospital Guntur
申办方类型
Research institution and hospital

研究点 (1)

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