Clinical trial NCT02910362: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Surgery
Lead sponsor: Intuor Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Abbott Medical Optics
First posted: 2016-09-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Number of Eyes With Stable IOP
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Eye Consultants
state: Arizona
Study officials:
affiliation: Arizona Eye Consultants
name: Sean McCafferty, MD
role: PRINCIPAL_INVESTIGATOR
References: