跳至主要内容
临床试验/NCT01385852
NCT01385852已完成4 期

Impact of Different Fluidic Parameters on Development of Cystoid Macular Edema Following Phacoemulsification

Iladevi Cataract and IOL Research Center2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年5月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
cystoid macular edema (CME)

研究概览

简要总结

Understanding and modulating fluid parameters is an important, but often overlooked aspect of phacoemulsification. In a previous study we compared the impact of using high fluid parameters versus low fluidic parameters on real-time IOP measured during phacoemulsification. The investigators found that using high parameters resulted in a higher absolute rise in IOP as well as higher fluctuations in the IOP when compared to low parameters. Clinically these higher fluctuations in IOP would translate in a higher chamber instability. Based on the results of this study, the investigators decided to take it further and study the impact of using high parameters (and thus, higher chamber instability) on macular edema and thickness following surgery, in an otherwise uncomplicated surgery.

Higher fluid parameters during phacoemulsification predisposes the eye to increased macular thickness

详细描述

Several studies have shown the adverse impact of an increase in the IOP and IOP fluctuations that occur during anterior segment intervention on the posterior segment structures. In human volunteers with each incremental increase in IOP the systolic and diastolic flow velocities in the short posterior ciliary arteries decreased linearly. This implies that the normal healthy eye is not able to autoregulate to maintain posterior ciliary artery blood flow velocities in response to acute large elevations in IOP. Vascular insufficiency due to abnormal autoregulation has been proposed as a major factor in the development of glaucoma. 1

It has been postulated that IOP elevation during the LASIK procedure causes mechanical stress which may induce tangential stress on the posterior segment.2, 3 Some studies have reported that the increase in IOP damages the retinal ganglion cells causing visual field defects. Also sudden increases in IOP, although well tolerated may induce changes in the peripheral retina.4,5,6

Several reports propose the occurrence of macular hole, lacquer cracks and choroidal neovascular membranes following the LASIK procedure. 3 It has been observed that the rapidly fluctuating pressure variations may be detrimental, particularly in susceptible persons with compromised ocular blood flow. Rapid IOP changes across a 30-mm Hg range would be predicted to influence posterior segment blood vessels.

In a previous study we compared the impact of using high fluid parameters versus low fluidic parameters on real-time IOP measured during phacoemulsification. We found that using high parameters resulted in a higher absolute rise in IOP as well as higher fluctuations in the IOP when compared to low parameters. Clinically these higher fluctuations in IOP would translate in a higher chamber instability.

We hypothesize that although transient, the increased IOP that occurs during phacoemulsification when using high parameters could cause mechanical stress on the eye. These higher fluid parameters during phacoemulsification can predispose the eye to increased macular thickness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Uncomplicated, Age-related cataract.
  • Nuclear sclerosis: upto grade 3
  • Age: 40-70 years
  • Axial length: 21.5 mm to 24.5 mm

排除标准

  • Diabetes mellitus
  • Co-existing ocular disease- uveitis, glaucoma, PEX
  • Pre-existing macular pathology (eg.ARMD)
  • Previously operated eyes
  • Under treatment with Topical or systemic steroids / NSAID's
  • Intraoperative complications- PCR, Descemet's detachment, uveal trauma
  • Post operative complications - severe inflammation (>grade 3), rise in IOP

结局指标

主要结局

cystoid macular edema (CME)

时间窗: 3 months

A \> or = 30% increase in baseline central foveal thickness measaured by anterior segment OCT will be defined as having CME.

次要结局

  • macular thickness(1, 3 months)
  • central corneal thickness (CCT)(first post-operative day,)
  • endothelial cell loss(6 months post-operative)
  • anterior chamber inflammation(1 months)
  • CORRECTED DISTANCE VISUAL ACUITY (CDVA)(3 months)

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)

Loading locations...

相似试验