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Comparing Two Cataract Surgery Systems

This study is comparing two systems, UNITY VCS/CS with UNITY 4D phaco handpiece and Centurion with OZil technology, used during cataract surgery. These systems help surgeons remove cataracts (cloudy lenses in your eyes). We want to see if one system is better at reducing the amount of energy used (Cumulative Dissipated Energy, CDE) and the time it takes to use ultrasound during the surgery. You may be able to join if you are 18 or older, need cataract surgery in both eyes, and have a specific type of cataract called nuclear sclerosis (grade 3 or above). The study plans to enroll 30 people, but its current status is unclear.

Study design
This interventional study will enroll 30 participants. It compares two different phacoemulsification systems used during cataract surgery.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Cumulative Dissipated Energy, is measured during the surgery (intraoperative).

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NCT07468877

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

Recruiting
NAAges 18+InterventionalTreatment
Nicole Fram M.D.
~30 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:Cataract extraction with phacoemulsification comparing two systems

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cumulative Dissipated Energy
Measured over Intraoperative

Conditions

Nuclear Sclerosis of the Lens
Phacoemulsification Cataract Surgery
Cataract Bilateral

Explore related trials

Cataract

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Nicole R Fram, M.D. · PRINCIPAL_INVESTIGATOR · Advanced Vision Care

Who to contact

Orly Shiler
[email protected]
3102291220
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Cumulative Dissipated EnergyIntraoperative

    CDE is a measure of the total ultrasound energy delivered into the eye during phacoemulsification cataract surgery