Cataract Surgery
Conditions
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.
Interventions
DEVICEAlcon phacoemulsification equipment
cataract surgery with Alcon phacoemulsification equipment.
DEVICEAMO phacoemulsification equipment
cataract surgery with AMO phacoemulsification equipment.
Sponsors
Abbott Medical Optics
Intuor Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eyes With Stable IOP | intraoperative | Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment. |
Countries
United States
Participant flow
Recruitment details
From September 2016 until December 2016,15 patients were enrolled at Arizona Eye Consultants clinic
Pre-assignment details
Patients were included in the study based upon meeting inclusion criteria and not meeting exclusion criteria. Patients were randomized to either group based upon a random number generator.
Participants by arm
| Arm | Count |
|---|---|
| Alcon Phacoemulsification Equipment cataract surgery performed with the Alcon phacoemulsification equipment
Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment. | 8 |
| Alcon Phacoemulsification Equipment cataract surgery performed with the Alcon phacoemulsification equipment
Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment. | 16 |
| AMO Phacoemulsification Equipment cataract surgery with the AMO phacoemulsification equipment
AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment. | 7 |
| AMO Phacoemulsification Equipment cataract surgery with the AMO phacoemulsification equipment
AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment. | 14 |
| Total | 45 |
Baseline characteristics
| Characteristic | Alcon Phacoemulsification Equipment | AMO Phacoemulsification Equipment | Total |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 8 | 66 years STANDARD_DEVIATION 8 | 66 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
Number of Eyes With Stable IOP
Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment.
Time frame: intraoperative
Population: Eyes with stable IOP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alcon Phacoemulsification Equipment | Number of Eyes With Stable IOP | 16 Eyes |
| AMO Phacoemulsification Equipment | Number of Eyes With Stable IOP | 14 Eyes |