Cataract
Conditions
Brief summary
Phacoemulsification is the most common treatment for cataract surgery in the developed countries and over the years it gained importance due to several factors: small incision, surgery performed under topical anesthesia - which reduce injection-related complications - short recovery time, low post operatory induced astigmatism, and low incidence of surgical complications, when compared to the conventional surgeries. The study evaluates 2 different phacoemulsification devices in patients undergoing routine cataract surgery in both eyes.
Interventions
DEVICEQuatera 700
Phacoemulsification device
DEVICECenturion
Phacoemulsification device
Sponsors
Carolina Eyecare Physicians, LLC
Science in Vision
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject is undergoing bilateral lens extraction with implantation of a posterior chamber intraocular lens. * Gender: Males and Females. * Age: 50 to 80 years old. * Willing and able to provide written informed consent for participation in the study * Willing and able to comply with scheduled visits and other study procedures. * Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 1 to 30 days between surgeries * Subjects requiring an IOL power in the range of +10.0 D to +30.0 D only. * Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
Exclusion criteria
* Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc. * Uncontrolled diabetes. * Use of any systemic or topical drug known to interfere with visual performance. * Contact lens use during the active treatment portion of the trial. * Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis. * Clinically significant corneal dystrophy. * Corneal irregularities potentially affecting visual acuity: keratoconus, corneal dystrophy, corneal opacities. * Endothelial cell count less than 1500 cells/mm2 * History of chronic intraocular inflammation. * History of retinal detachment. * Femtosecond arcuates at time of surgery. * Femtosecond laser assisted cataract surgery in one eye only. * Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules. * Previous intraocular surgery. * Previous radial keratoromy (RK). * Previous keratoplasty * Pupil abnormalities * Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e. LASIK) * Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc). * Other ocular procedures at the time of the cataract extraction (i.e., iStent) * Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results. * Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Corneal Thickness | Postoperative day 1 | Ultrasound pachymetry |
| Lens Removal Time | Intraoperative | from end of rhexis to complete nucleus removal |
Countries
United States
Participant flow
Pre-assignment details
This was a split-eye study design. Each participant contributed two eyes, with one eye assigned to each intervention arm. Therefore, participants appear in both arms and may be counted more than once across arms in the Participant Flow table.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 70.7 years STANDARD_DEVIATION 6.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 3 / 40 | 4 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
None listed