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CME With Different Fluidic Parameters

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Iladevi Cataract and IOL Research Center

關鍵詞

抽象

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

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.

To the best of our knowledge there are no published data on impact of IOP changes and fluctuation that are induced during cataract surgery on the macula. To investigate this further, we decided to study the impact of using high parameters (and thus, higher chamber instability) on macular thickness following surgery, in an otherwise uncomplicated surgery.

日期

最後驗證: 05/31/2012
首次提交: 06/27/2011
提交的預估入學人數: 06/28/2011
首次發布: 06/29/2011
上次提交的更新: 06/04/2012
最近更新發布: 06/05/2012
實際學習開始日期: 04/30/2010
預計主要完成日期: 01/31/2011
預計完成日期: 07/31/2011

狀況或疾病

Cystoid Macular Edema Following Cataract Surgery

干預/治療

Procedure: microcoaxial phacoemulsification

相 4

手臂組

干預/治療
Active Comparator: Longitudinal U/S - low fluidic
ASPIRATION FLOW RATE - 25 CC/MIN, BOTTLE HEIGHT - 90 CMS, LONGITUDINAL ULTRASOUND
Active Comparator: Torsional U/S - low fluidic
ASPIRATION FLOW RATE - 25 CC/MIN, BOTTLE HEIGHT - 90 CMS, TORSIONAL ULTRASOUND
Active Comparator: Longitudinal U/S - high fluidic
ASPIRATION FLOW RATE - 40 CC/MIN, BOTTLE HEIGHT - 110 CMS, LONGITUDINAL ULTRASOUND

資格標準

有資格學習的年齡 40 Years 至 40 Years
有資格學習的性別All
接受健康志願者
標準

Inclusion Criteria:

1. Uncomplicated, Age-related cataract.

2. Nuclear sclerosis: upto grade 3

3. Age: 40-70 years

4. Axial length: 21.5 mm to 24.5 mm

Exclusion Criteria:

1. Diabetes mellitus

2. Co-existing ocular disease- uveitis, glaucoma, PEX

3. Pre-existing macular pathology (eg.ARMD)

4. Previously operated eyes

5. Under treatment with Topical or systemic steroids / NSAID's

6. Intraoperative complications- PCR, Descemet's detachment, uveal trauma

7. Post operative complications - severe inflammation (>grade 3), rise in IOP

結果

主要結果指標

1. cystoid macular edema (CME) [3 months]

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

次要成果指標

1. macular thickness [1, 3 months]

macular thickness measured in 3 zones using the anterior segment OCT

2. central corneal thickness (CCT) [first post-operative day,]

CCT will be measured on the ultrasound pachymeter by a single experienced observer

3. endothelial cell loss [6 months post-operative]

Endothelial cell loss will be measured using a specular microscope in the central area by a single technician

4. anterior chamber inflammation [1 months]

it will be assessed on the slit lamp examination by a single experienced observer using the Hogan's criteria

5. CORRECTED DISTANCE VISUAL ACUITY (CDVA) [3 months]

visual acuity (VA) of 20/40 or worse was defined as "clinically significant"

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