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

NCT ID: NCT02910362

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-01-31

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.

Conditions

Cataract Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Alcon phacoemulsification equipment

cataract surgery performed with the Alcon phacoemulsification equipment

Group Type: EXPERIMENTAL

Alcon phacoemulsification equipment

Intervention Type: DEVICE

cataract surgery with Alcon phacoemulsification equipment.

AMO phacoemulsification equipment

cataract surgery with the AMO phacoemulsification equipment

Group Type: ACTIVE_COMPARATOR

AMO phacoemulsification equipment

Intervention Type: DEVICE

cataract surgery with AMO phacoemulsification equipment.

Interventions

Alcon phacoemulsification equipment

cataract surgery with Alcon phacoemulsification equipment.

Intervention Type: DEVICE

AMO phacoemulsification equipment

cataract surgery with AMO phacoemulsification equipment.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Optics

INDUSTRY

Sponsor Role: collaborator

Intuor Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean McCafferty, MD

Role: PRINCIPAL_INVESTIGATOR

Arizona Eye Consultants

Locations

Arizona Eye Consultants

Tucson, Arizona, United States

Countries

United States

Other Identifiers

CP-02

Identifier Type: -

Identifier Source: org_study_id