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NCT Number: 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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advanced Vision Care

Los Angeles, California, 90067, United States

Location status: Recruiting

Location contact

Nicole R Fram, M.D.

PRINCIPAL_INVESTIGATOR

Orly Shiler

CONTACT

[email protected]

8183919507

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cataract extraction with phacoemulsification comparing two systems

Device

First arm: Phacoemulsification using UNITY VCS/CS system with UNITY 4D phaco handpiece

Primary outcomes

  1. Cumulative Dissipated Energy

    Time frame: Intraoperative

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

Secondary outcomes

  1. Total Ultrasound Time

    Time frame: Intraoperative

    The time it takes to emulsify the lens material during cataract surgery

Other outcomes

  1. Total Aspiration Time

    Time frame: Intraoperative

    The total duration the surgeon spends removing lens material and cortical debris using the aspiration handpiece

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Orly Shiler

CONTACT

[email protected]

3102291220

Sponsors and collaborators

Lead sponsor

Nicole Fram M.D.

Other

Registry information

Official study title

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

Acronym: CDE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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