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NCT Number: NCT01385852

CME With Different Fluidic Parameters

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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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Raghudeep Eye Clinic

Ahmedabad, Gujarat, 380013, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microcoaxial Phacoemulsification

Procedure

conventional longitudinal ultrasound

Other names: phacoemulsification, small incision cataract surgery

Primary outcomes

  1. cystoid macular edema (CME)

    Time frame: 3 months

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

Secondary outcomes

  1. macular thickness

    Time frame: 1, 3 months

    macular thickness measured in 3 zones using the anterior segment OCT

  2. central corneal thickness (CCT)

    Time frame: first post-operative day,

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

  3. endothelial cell loss

    Time frame: 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

    Time frame: 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)

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Iladevi Cataract and IOL Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 30, 2011
Registry last updated
Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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