NCT07468877 · Nicole Fram M.D.
This Clinical Trial Compares Two Phacoemulsification Systems Used in a Bilateral Cataract Surgery Subjects in Order to Study CDE and Ultrasound Time During Cataract Removal
(CDE)
What this study is about
This clinical trial compares two phacoemulsification systems used in a bilateral cataract surgery subjects, in order to study CDE and Ultrasound time during cataract removal
View original scientific description
This clinical trial compares two phacoemulsification systems used in a bilateral cataract surgery subjects, in order to study CDE and Ultrasound time during cataract removal
Interventions
DEVICE
Cataract extraction with phacoemulsification comparing two systems
First arm: Phacoemulsification using UNITY VCS/CS system with UNITY 4D phaco handpiece
DEVICE
Cataract extraction with phacoemulsification comparing two systems
Second arm: Phacoemulsification using Centurion system with OZil technology
Primary outcome measures
Cumulative Dissipated Energy
Time frame: Intraoperative
CDE is a measure of the total ultrasound energy delivered into the eye during phacoemulsification cataract surgery
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Healthy patients 18 years or older undergoing uncomplicated sequential bilateral cataract surgery with phacoemulsification and IOL implantation
- Expected to undergo sequential cataract surgery in both eyes
- Must have bilateral nuclear sclerosis cataracts classified using LOCS III as grade 3 or above (see appendix III)
- Both eyes will be operated on by the same surgeon
- Have the ability to consent for study and procedure planned
Exclusion criteria
- Patients under 18 years of age.
- Complex cataract cases involving zonulopathy (e.g., pseudoexfoliation syndrome, traumatic zonular weakness) that may require use of zonular support devices during surgery (e.g. capsular hooks) and/or implantation of capsular tension rings or other zonular support devices, and in the investigator's judgment, may interfere with the surgical procedure or study outcome measures.
- Require mechanical pupil expanding devices (e.g., iris hooks, Malyugin rings, etc.)
- Undergoing femtosecond laser-assisted lens fragmentation.
- Surgical complications, in the opinion of the investigator, occurring either intraoperatively or postoperatively (including capsule tears, iris trauma, or decentered intraocular lens) and not attributable to the study device or study design.
- Prior ocular surgery (including intraocular, oculoplastic, corneal or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment, if it interferes with the outcome measures of this study.
- Presence of endothelial cell dystrophies and/or corneal comorbidities.
- History of intraocular inflammation (e.g., uveitis, iritis).
- History of retinal edema or presence of a clinically significant epiretinal membrane that, in the investigator's clinical judgment, may interfere with the outcome measures of this study.
- History of retinal surgery (e.g.retinal detachment repair, membrane peel) involving vitrectomy.
- Dense brunescent cataract that in the investigator's clinical judgment, may interfere with the outcome measures of this study.
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 18, 2026 · Source of record for eligibility and locations