跳至主要内容
临床试验/CTRI/2015/09/006191
CTRI/2015/09/006191尚未招募4 期

Intraoperative performance and postoperative outcomes following femtosecond laser assisted cataract surgery (FLACS) and manual phacoemulsification in eyes with shallow anterior chambers

Alcon Laboratories Inc1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2015年1月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
182
试验地点
1
主要终点
Corneal thickness measured by ultrasonic pachymetry on day 1, week 1 and 1 month (Change in corneal thickness of 15% from preop. will be considered significant).

研究概览

简要总结

This study aims to compare intraoperative performance and post operative outcomes following femtosecond laser assisted phacoemulsification vs. traditional phacoemulsification in eyes with age related cataract and shallow anterior chamber.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • Adult male or female patients requiring cataract surgery at least in one eye.

排除标准

  • Coexisting ocular morbidity, inability to come for followup.

结局指标

主要结局

Corneal thickness measured by ultrasonic pachymetry on day 1, week 1 and 1 month (Change in corneal thickness of 15% from preop. will be considered significant).

时间窗: Corneal thickness measured by ultrasonic pachymetry on day 1, week 1 and 1 month (Change in corneal thickness of 15% from preop. will be considered significant).

次要结局

  • Anterior chamber cells, Presence of Descemats folds, Presence of Descemats detachment,Percentage change in endothelial cell, Iris damage on slit lamp examination, unaided visual acuity, best corrected distance visual acuity, surgeons grading of intraoperative difficulty(1 week, 1 month and 3 months)

研究者

申办方类型
Pharmaceutical industry-Global

研究点 (1)

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