Intra-surgical Evaluation of CATS Tonometer Prism and Abbott Medical Optics Versus Alcon Phacoemulsification Machines
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/13/2018 |
| Start Date: | September 2016 |
| End Date: | January 2017 |
Intra-surgical Evaluation of CATS Tonometer Prism and AMO Versus Alcon Phacoemulsification Machines
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.
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.
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
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