跳至主要内容
临床试验/CTRI/2021/12/038418
CTRI/2021/12/038418尚未招募不适用

TO EVALUATE THE SAFETY , EFFICACY AND PREDICTABILITY OF FEMTOSECOND LASER (LENSAR) ENABLED ARCUATE INCISIONS FOR THE CORRECTION OF PREOPERATIVE TOPOGRAPHIC ASTIGMATISM AT THE TIME OF CATARACT SURGERY

LENSAR1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年12月16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 EVALUATE THE EFFICACY SAFETY AND PREDICTABILITY OF ARCUATE INCISIONS TO CORRECT CORNEAL ASTIGMATISM CREATED BY THE LENSAR FEMTOSECOND LASER DEVICE

研究概览

简要总结

Phacoemulsification is the gold standard for cataract surgery. With constant improvements and continuous upgradations, most of the modern phacoemulsification systems on the market have improved on safety and efficacy, leading to reduced surgical times and lower rates of intra-operative complications, translating into better postoperative outcomes and patient satisfaction. Surgical efficiency, however, may vary, depending upon the surgeon’s skills as well as the machine settings. A good clinical outcome depends on the combination of both.

In line with these advancements, a new femtosecond laser system “LENSAR†has been recently updated to correct the topographic pre-operative astigmatism by arcuate incisions. The system has a unique ability to mark the arcuate incision on the cornea with the inbuilt woodcock nomogram, the reference image can directly be transferred to the LENSAR from the Pentacam, or if old versions of Pentacam are used it can also be transferred through an external hard disk, the device also has a unique ability to auto correct the cyclorotation by iris identification software after the patient is in supine position to maximize the results.

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
40.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • CATARACT EYES WITH NO COMORBIDITIES ASTIGMATISM OF -0.75D TO -2D UNILATERAL EYE.

排除标准

  • CORNEAL ECTATIC CONDITIONS CORNEAL SCARS PTERYGIUM POST REFRACTIVE SURGERY GLAUCOMA RETINAL PATHOLOGIES.

结局指标

主要结局

TO EVALUATE THE EFFICACY SAFETY AND PREDICTABILITY OF ARCUATE INCISIONS TO CORRECT CORNEAL ASTIGMATISM CREATED BY THE LENSAR FEMTOSECOND LASER DEVICE

时间窗: PREOP , POSTOP-1DAY,3MONTHS , 12 MONTHS

次要结局

  • TO EVALUATE REGRESSION OF ASTIGMATISM IN THE NEXT 12 MONTHS FOLLOW UP PERIOD(PREOP , POSTOP-1DAY,3MONTHS , 12 MONTHS)

研究者

发起方
LENSAR
申办方类型
Research institution

研究点 (1)

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