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

Intra-surgical Evaluation of CATS Tonometer Prism and AMO 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.

Study Overview

• Status: Completed
• Conditions: Cataract Surgery
• Intervention / Treatment: Device: Alcon phacoemulsification equipment; Device: AMO phacoemulsification equipment

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Arizona Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Alcon phacoemulsification equipment; cataract surgery performed with the Alcon phacoemulsification equipment	Device: Alcon phacoemulsification equipment; cataract surgery with Alcon phacoemulsification equipment.
ACTIVE_COMPARATOR: AMO phacoemulsification equipment; cataract surgery with the AMO phacoemulsification equipment	Device: AMO phacoemulsification equipment; cataract surgery with AMO phacoemulsification equipment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Eyes With Stable IOP	Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment.	intraoperative

Collaborators and Investigators

• Sponsor: Intuor Technologies, Inc.
• Collaborators: Abbott Medical Optics

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: September 13, 2016
• First Submitted That Met QC Criteria: September 19, 2016
• First Posted (ESTIMATE): September 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 7, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CP-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO