- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06225362
Quatera 700 vs. Centurion
January 29, 2024 updated by: Carolina Eyecare Physicians, LLC
Evaluation and Clinical Outcomes After Routine Cataract Surgery With the Quatera® 700 and the Centurion® Vision System
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Helga P. Sandoval
- Phone Number: 8438813937
- Email: hps@cepmd.com
Study Locations
-
-
South Carolina
-
Mount Pleasant, South Carolina, United States, 29464
- Recruiting
- Carolina EyeCare Physicians, LLC
-
Principal Investigator:
- Kerry D Solomon, MD
-
Contact:
- Helga P Sandoval, MD, MSCR
- Phone Number: 843-881-3937
- Email: helga.sandoval@carolinaeyecare.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Quatera 700
|
Phacoemulsification device
|
Active Comparator: Centurion Vision System
|
Phacoemulsification device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Central corneal thickness
Time Frame: Postoperative day 1
|
Postoperative day 1
|
|
Lens removal time
Time Frame: Intraoperative
|
from end of rhexis to complete nucleus removal
|
Intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2024
Primary Completion (Estimated)
August 30, 2024
Study Completion (Estimated)
August 30, 2024
Study Registration Dates
First Submitted
January 16, 2024
First Submitted That Met QC Criteria
January 17, 2024
First Posted (Actual)
January 25, 2024
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 29, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP 23-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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