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)

March 16, 2026 updated by: Nicole Fram M.D.

Cumulative Dissipated Energy (CDE) and Total Phacoemulsification Energy (Joules) of Unity VCS/CS With 4D Phaco Compared to Centurion System With OZil

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Unity and Centurion are two phacoemulsification systems routinely used during cataract surgery to assist the surgeon in removing the cataractous lens from the eye. This clinical trial aims to compare the performance of Unity versus Centurion during standard cataract surgery.

The primary objective of this study is to explore CDE and Ultrasound time during cataract extraction compared to Centurion.

This study will enroll 30 subjects (60 eyes) diagnosed with Nuclear Sclerosis cataract who require cataract surgery with intraocular lens implantation in both eyes.

Study Type

Interventional

Enrollment (Estimated)

30

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

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90067
        • Recruiting
        • Advanced Vision Care
        • Contact:
        • Principal Investigator:
          • Nicole R Fram, M.D.

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:

  • 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.

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Unity VCS/CS with 4D Phaco Handpiece
Patients are generally randomized to undergo surgery with Unity VCS/CS system with 4D phacoemulsification on one of there eyes
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
Active Comparator: Centurion vision system with OZil Handpiece
Patients are generally randomized to undergo surgery with Centurion system with OZil technology phacoemulsification on one of there eyes
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Dissipated Energy
Time Frame: Intraoperative
CDE is a measure of the total ultrasound energy delivered into the eye during phacoemulsification cataract surgery
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Ultrasound Time
Time Frame: Intraoperative
The time it takes to emulsify the lens material during cataract surgery
Intraoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Aspiration Time
Time Frame: Intraoperative
The total duration the surgeon spends removing lens material and cortical debris using the aspiration handpiece
Intraoperative
Central Corneal Thickness
Time Frame: post op day 1
Onset and changes in corneal thickness after phacoemulsification performed by Unity vs Centurion Ozil, measured at the apex using Pentacam
post op day 1
Anterior chamber inflammation
Time Frame: Post op day 1 and Post op day 7
Onset and changes in AC inflammation after phacoemulsification performed by Unity vs Centurion Ozil, Assessed during slit-lamp examination using SUN criteria
Post op day 1 and Post op day 7
Presence of Berger space
Time Frame: Post op day 1
Onset and changes in Space between posterior capsule and vitreous body after phacoemulsification performed by Unity vs Centurion Ozil, measured by AS-OCT
Post op day 1
Macular thickness
Time Frame: Post op day 7
Onset and changes in retinal thickness and incidents of CME after phacoemulsification performed with Unity vs Centurion Ozil, Measured by MAC OCT
Post op day 7
Average Ganglian Cell and Inner plexiform layer thickness
Time Frame: Post op day 7
Onset and changes in Average Ganglian Cell and Inner plexiform layer thickness after phacoemulsification performed with Unity vs Centurion Ozil, measured by OCT
Post op day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nicole Fram M.D.

Investigators

  • Principal Investigator: Nicole R Fram, M.D., Advanced Vision Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 13, 2026

Primary Completion (Estimated)

February 13, 2027

Study Completion (Estimated)

February 13, 2027

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVC-008
  • 1405359 (Other Identifier: WCG IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In part due to : risk of Re-identification and Informed Consent Limitations.

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.

No

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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