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临床试验/NCT03587909
NCT03587909已完成不适用

Intraoperative Performance and Postoperative Outcomes Following Femtosecond Laser Assisted Cataract Surgery (FLACS) and Manual Phacoemulsification in Eyes With Shallow Anterior Chamber

Iladevi Cataract and IOL Research Center2 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
91
试验地点
2
主要终点
Central Corneal Thickness

研究概览

简要总结

Phacoemulsification in eyes with a shallow anterior chamber (ACD < 2.2mm) presents with problems of safe access to the cataract and increased vulnerability of the endothelium and a higher tendency of complications such as descemet's detachment and iris prolapse. A shallow anterior chamber is also responsible for the high incidence of glaucoma and postoperative complications after cataract surgery. Femtosecond assisted cataract surgery has made cataract surgery safer and more predictable. The effective phacoemulsification time and intra-operative manipulation is greatly reduced in FLACS. However phacoemulsification still remains the most widely performed cataract surgery around the world. Post-operative outcomes after phacoemulsification in patients having shallow anterior chamber have been extensively reported in literature over the years.

There is no head to head comparison in terms of intraoperative performance and post-operative outcomes between FLACS and phacoemulsification in eyes with shallow anterior chamber.

The aim is to compare the intra-operative performance and post-operative outcomes in eyes undergoing femtosecond laser assisted cataract surgery versus eyes undergoing phacoemulsification in eyes having shallow anterior chamber.

The study will bring an understanding on the question: Do patients undergoing Femtosecond laser assisted cataract surgery behave differently from those undergoing phacoemulsification?

详细描述

Inclusion Criteria:

  • Age-related cataract
  • Shallow Anterior Chamber (<2.5mm)

Exclusion Criteria:

-Ocular co-morbidity - corneal disorders, glaucoma, uveitis, previous ocular surgery

Surgical Technique :

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • uncomplicated, age related cataracts
  • Shallow anterior chamber (measured as </=2.5mm )

排除标准

  • Coexisting ocular morbidity,
  • inability to come for followup

研究组 & 干预措施

Phacoemulsification Cataract Surgery

Active Comparator

Procedure / Surgery : Phacoemulsification Surgery

干预措施: Phacoemulsification Cataract SUrgery (Procedure)

Femtosecond Cataract Surgery

Active Comparator

Procedure / SUrgery - Femtosecond Laser Cataract surgery

干预措施: Femtosecond Cataract Surgery (Procedure)

结局指标

主要结局

Central Corneal Thickness

时间窗: Postoperative Day 1

Central Corneal Thickness

次要结局

  • Endothelial Cell Morphology(Postoperative 6 months)
  • Anterior Chamber Inflammation(Postoperative Day 1)

研究者

发起方
Iladevi Cataract and IOL Research Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abhay R. Vasavada

Principal Investigator

Iladevi Cataract and IOL Research Center

研究点 (2)

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