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

Cataract Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910362
• Other study ID #: CP-02
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: January 2017

Study information

• Verified date: October 2018
• Source: Intuor Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery

Intervention

Device:
• Alcon phacoemulsification equipment
cataract surgery with Alcon phacoemulsification equipment.
• AMO phacoemulsification equipment
cataract surgery with AMO phacoemulsification equipment.

Locations

Country	Name	City	State
United States	Arizona Eye Consultants	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Intuor Technologies, Inc.	Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Eyes With Stable IOP	Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment.	intraoperative