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

Primary Purpose

Cataract Surgery

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcon phacoemulsification equipment
AMO phacoemulsification equipment
Sponsored by
Intuor Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cataract Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Eye Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alcon phacoemulsification equipment

AMO phacoemulsification equipment

Arm Description

cataract surgery performed with the Alcon phacoemulsification equipment

cataract surgery with the AMO phacoemulsification equipment

Outcomes

Primary Outcome Measures

Number of Eyes With Stable IOP
Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2016
Last Updated
October 7, 2018
Sponsor
Intuor Technologies, Inc.
Collaborators
Abbott Medical Optics
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1. Study Identification

Unique Protocol Identification Number
NCT02910362
Brief Title
Intra-surgical Evaluation of CATS Tonometer Prism and Abbott Medical Optics Versus Alcon Phacoemulsification Machines
Official Title
Intra-surgical Evaluation of CATS Tonometer Prism and AMO Versus Alcon Phacoemulsification Machines
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intuor Technologies, Inc.
Collaborators
Abbott Medical Optics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcon phacoemulsification equipment
Arm Type
Experimental
Arm Description
cataract surgery performed with the Alcon phacoemulsification equipment
Arm Title
AMO phacoemulsification equipment
Arm Type
Active Comparator
Arm Description
cataract surgery with the AMO phacoemulsification equipment
Intervention Type
Device
Intervention Name(s)
Alcon phacoemulsification equipment
Intervention Description
cataract surgery with Alcon phacoemulsification equipment.
Intervention Type
Device
Intervention Name(s)
AMO phacoemulsification equipment
Intervention Description
cataract surgery with AMO phacoemulsification equipment.
Primary Outcome Measure Information:
Title
Number of Eyes With Stable IOP
Description
Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment.
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean McCafferty, MD
Organizational Affiliation
Arizona Eye Consultants
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Eye Consultants
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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