跳至主要内容
临床试验/CTRI/2021/12/038887
CTRI/2021/12/038887尚未招募不适用

Comparison of safety,efficacy and post operative endothelial cell density following standard phacoemulsification versus LENSAR femtosecond laser assisted cataract surgery in dense cataract.

LENSAR1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
LENSAR
入组人数
100
试验地点
1
主要终点
To compare the intra-operative cumulative dissipated energy (CDE), total surgical time and complication rates between the two groups.

研究概览

简要总结

FLACS(Femtosecond assisted cataract surgery) is the deviced to give most precise, accurate results following cataract surgery. Several studies have been performed to check for safety and efficacy of FLACS vs standard phacoemulsification in harder cataract. LENSAR FS laser system has been introduced, whichincorporates Augmented Reality through advanced Scheimpflug imaging, raytracing and 3D confocal structured illumination (3D-CSI) to construct athree-dimensional model of the anterior segment of the eye including the corneaand lens.Turretssoftware available in LENSAR FS system enables use of chop and fragmentationpatterns. It is an extended fragmentation region near the center of theanterior capsule governed by two parameters: Max Turret Radius ( radial extentof the turret) and Extend Turret ( extent of the turret above the capsule; mustbe negative to avoid affecting the capsulotomy button). The softwareconsolidates 16 individual high resolution Scheimpflug images from 8 angularpositions to identify the major interfaces ie anterior and posterior cornealsurface and anterior and posterior lens capsule, details of the location anddensity of the lens nucleus and the boundaries between endonucleus, epinucleusand cortex , thus allowing automated grading of cataract density andcustomization of phacofragmentation and reducing cumulative dissipated energy(CDE) minimising potential for inflammation and endothelial cell loss.This prospective, non-randomized study will thusbe conducted  to investigate the intra-operativecumulative dissipated energy (CDE) and endothelial cell density (ECD) in densecataracts following  standardphacoemulsification surgery versus FLACS with LENSAR FS laser system over along term follow-up of 12 months.

研究设计

研究类型
Interventional
分配方式
Not Applicable

入排标准

年龄范围
40.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with cataract grade 3 or more (according to LOCS III classification) 2.Subjects willing and able to understand and sign informed consent.
  • 3.Subjects willing and able to attend postoperative examinations per protocol schedule.

排除标准

  • 1.Patients with endothelial cell density less than 1500 cells/mm2 2.Pupil diameter less than 6mm or pupillary abnormality.
  • 3.Subluxated cataract 4.Post uveitic cataract 5.Traumatic cataract 6.Corneal opacity 7.Pterygium greater than grade 2.

结局指标

主要结局

To compare the intra-operative cumulative dissipated energy (CDE), total surgical time and complication rates between the two groups.

时间窗: PRE OPERATIVE, INTRAOPERATIVE,FOLLOW UP DAY 1, FOLLOW UP 2 WEEKS, FOLLOW UP 6 MONTHS AND 1 YEAR.

次要结局

  • best corrected visual acuity, endothelial cell density,intraocular pressure.(PRE OPERATIVE, INTRAOPERATIVE,FOLLOW UP DAY 1, FOLLOW UP 2 WEEKS, FOLLOW UP 6 MONTHS AND 1 YEAR.)

研究者

发起方
LENSAR
申办方类型
Research institution

研究点 (1)

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