CME With Different Fluidic Parameters

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Cystoid Macular Edema Following Cataract Surgery

Intervention / Treatment
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* Procedure: microcoaxial phacoemulsification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uncomplicated, Age-related cataract. Nuclear sclerosis: upto grade 3 Age: 40-70 years Axial length: 21.5 mm to 24.5 mm Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Longitudinal U/S - low fluidic<br>ASPIRATION FLOW RATE - 25 CC/MIN, BOTTLE HEIGHT - 90 CMS, LONGITUDINAL ULTRASOUND | Procedure: microcoaxial phacoemulsification<br>* conventional longitudinal ultrasound<br>* Other names: small incision cataract surgery;|
| Active Comparator: Torsional U/S - low fluidic<br>ASPIRATION FLOW RATE - 25 CC/MIN, BOTTLE HEIGHT - 90 CMS, TORSIONAL ULTRASOUND | Procedure: microcoaxial phacoemulsification<br>* conventional longitudinal ultrasound<br>* Other names: small incision cataract surgery;|
| Active Comparator: Longitudinal U/S - high fluidic<br>ASPIRATION FLOW RATE - 40 CC/MIN, BOTTLE HEIGHT - 110 CMS, LONGITUDINAL ULTRASOUND | Procedure: microcoaxial phacoemulsification<br>* conventional longitudinal ultrasound<br>* Other names: small incision cataract surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cystoid macular edema (CME) | A > or = 30% increase in baseline central foveal thickness measaured by anterior segment OCT will be defined as having CME. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| macular thickness | macular thickness measured in 3 zones using the anterior segment OCT | 1, 3 months | 
| central corneal thickness (CCT) | CCT will be measured on the ultrasound pachymeter by a single experienced observer | first post-operative day, | 
| endothelial cell loss | Endothelial cell loss will be measured using a specular microscope in the central area by a single technician | 6 months post-operative | 
| anterior chamber inflammation | it will be assessed on the slit lamp examination by a single experienced observer using the Hogan's criteria | 1 months | 
| CORRECTED DISTANCE VISUAL ACUITY (CDVA) | visual acuity (VA) of 20/40 or worse was defined as clinically significant | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CME, OCT, Optical coherence tomography, macular thickness