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Completed

NCT Number: NCT02910362

Intra-surgical Evaluation of CATS Tonometer Prism and Abbott Medical Optics Versus Alcon Phacoemulsification Machines

This study will measure the dynamic real-time intraocular pressure (IOP) in the anterior chamber during standard phacoemulsification surgery.

What is known:

* Fluidics control is determined to be one of the primary drivers of physician decision making in choosing phacoemulsification equipment. * Active pressure system fluidic control has a perceived and possibly real (based upon recent literature) improvement in intra-cameral IOP stability and reduced pressure fluctuations. * Improved fluidics can allow for reduced dynamic IOP fluctuations, in-the-bag positioned phaco tip, and intra-cameral fluid flow all of which will likely improve corneal health post-operatively.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Eye Consultants

Tucson, Arizona, 85710, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Age 18 or greater
  • Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
  • Subjects able to give informed consent
  • Nuclear Sclerotic cataract graded 2+ or 3+
  • Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for both eyes
  • Preoperative corneal astigmatism of 2.5 D or less
  • Ages between 55 and 80
  • Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion criteria

  • • Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
  • Intraoperative complications
  • Subjects with only one functional eye
  • Those with one eye having poor or eccentric fixation
  • Mild or severe cataracts, predominantly posterior subcapsular cataracts
  • High corneal astigmatism (i.e. those eyes displaying an oval contact image)
  • Those with corneal scarring or who have had corneal surgery including corneal laser surgery
  • Microphthalmos
  • Buphthalmos
  • Severe Dry eyes
  • Blepharospasm
  • Nystagmus
  • Keratoconus
  • Any other corneal or conjunctival pathology or infection.
  • Central corneal thickness greater than 0,600 mm or less than 0,500 mm (2 standard deviations about the human mean)
  • Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
  • Uncontrolled systemic or ocular disease
  • History of ocular trauma or prior ocular surgery
  • Fuchs Dystrophy
  • Subjects who may be expected to require retinal laser treatment or other surgical intervention, including LRI's
  • Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
  • Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
  • Contact lens usage within 6 months for PMMA contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lens

Treatment and study plan

Alcon phacoemulsification equipment

Device

cataract surgery with Alcon phacoemulsification equipment.

AMO phacoemulsification equipment

Device

cataract surgery with AMO phacoemulsification equipment.

Primary outcomes

  1. Number of Eyes With Stable IOP

    Time frame: intraoperative

    Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment.

Sponsors and collaborators

Lead sponsor

Intuor Technologies, Inc.

Industry

Collaborators

  • Abbott Medical Optics

Registry information

Official study title

Intra-surgical Evaluation of CATS Tonometer Prism and AMO Versus Alcon Phacoemulsification Machines

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 22, 2016
Registry last updated
Oct 11, 2018

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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