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

Intuor Technologies

Status

Completed

Conditions

Cataract Surgery

Treatments

Device: AMO phacoemulsification equipment

Device: Alcon phacoemulsification equipment

Study type

Interventional

Funder types

Industry

Identifiers

NCT02910362

CP-02

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No 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