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

Last updated: March 16, 2026
Sponsor: Nicole Fram M.D.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Eye Disease

Vision Loss

Treatment

Cataract extraction with phacoemulsification comparing two systems

Clinical Study ID

NCT07468877
AVC-008
1405359
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy patients 18 years or older undergoing uncomplicated sequential bilateralcataract 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 3or 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

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 duringsurgery (e.g. capsular hooks) and/or implantation of capsular tension rings or otherzonular support devices, and in the investigator's judgment, may interfere with thesurgical 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 eitherintraoperatively or postoperatively (including capsule tears, iris trauma, ordecentered intraocular lens) and not attributable to the study device or studydesign.

  • Prior ocular surgery (including intraocular, oculoplastic, corneal or refractivesurgical procedure) performed within the last 3 months or at any time that in theinvestigator's clinical judgment, if it interferes with the outcome measures of thisstudy.

  • 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 membranethat, in the investigator's clinical judgment, may interfere with the outcomemeasures of this study.

  • History of retinal surgery (e.g.retinal detachment repair, membrane peel) involvingvitrectomy.

  • Dense brunescent cataract that in the investigator's clinical judgment, mayinterfere with the outcome measures of this study.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Cataract extraction with phacoemulsification comparing two systems
Phase:
Study Start date:
February 13, 2026
Estimated Completion Date:
February 13, 2027

Study 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.

Connect with a study center

  • Advanced Vision Care

    Los Angeles, California 90067
    United States

    Active - Recruiting

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