Comparison of two phacoemulsification devices for cataract surgery
Evaluation and Clinical Outcomes After Routine Cataract Surgery With the Quatera® 700 and the Centurion® Vision System
This study tests which of two cataract surgery devices, Quatera 700 or Centurion, helps patients see better and recover faster after having surgery in both eyes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Carolina Eyecare Physicians, LLC Academic / other |
| Locations | 1 site (Mount Pleasant, South Carolina) |
| Trial ID | NCT06225362 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two different phacoemulsification devices, Quatera 700 and Centurion, in patients undergoing routine cataract surgery in both eyes. The trial focuses on patients who are scheduled for bilateral lens extraction with the implantation of a posterior chamber intraocular lens. Participants will be monitored for postoperative outcomes, including visual acuity and recovery times, to determine which device offers superior results. The study aims to enhance the safety and efficacy of cataract surgery procedures.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 50 to 80 who are undergoing bilateral cataract surgery with specific intraocular lens power requirements.
Not a fit: Patients with severe preoperative ocular pathologies or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and faster recovery times for cataract patients.
How similar studies have performed: Previous studies comparing phacoemulsification devices have shown promising results, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Solomon KD, DeOliveira A, Sandoval HP 4 CONFIDENTIAL CEP 23-002 Version 1.0/27Jul2023 * 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.
Where this trial is running
Mount Pleasant, South Carolina
- Carolina Eyecare Physicians, LLC — Mount Pleasant, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Helga P. Sandoval
- Email: hps@cepmd.com
- Phone: 8438813937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.