CME With Different Fluidic Parameters

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-08-31

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

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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.

Conditions

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Cystoid Macular Edema Following Cataract Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Longitudinal U/S - low fluidic

ASPIRATION FLOW RATE - 25 CC/MIN, BOTTLE HEIGHT - 90 CMS, LONGITUDINAL ULTRASOUND

Group Type ACTIVE_COMPARATOR

microcoaxial phacoemulsification

Intervention Type PROCEDURE

conventional longitudinal ultrasound

Torsional U/S - low fluidic

ASPIRATION FLOW RATE - 25 CC/MIN, BOTTLE HEIGHT - 90 CMS, TORSIONAL ULTRASOUND

Group Type ACTIVE_COMPARATOR

microcoaxial phacoemulsification

Intervention Type PROCEDURE

conventional longitudinal ultrasound

Longitudinal U/S - high fluidic

ASPIRATION FLOW RATE - 40 CC/MIN, BOTTLE HEIGHT - 110 CMS, LONGITUDINAL ULTRASOUND

Group Type ACTIVE_COMPARATOR

microcoaxial phacoemulsification

Intervention Type PROCEDURE

conventional longitudinal ultrasound

Interventions

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microcoaxial phacoemulsification

conventional longitudinal ultrasound

Intervention Type PROCEDURE

Other Intervention Names

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phacoemulsification small incision cataract surgery

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes