Recruiting

Phacoemulsification Systems

Sponsor:

Nicole Fram M.D.

Code:

NCT07468877

Conditions

Nuclear Sclerosis of the Lens

Phacoemulsification Cataract Surgery

Cataract Bilateral

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cataract extraction with phacoemulsification comparing two systems

Cataract extraction with phacoemulsification comparing two systems

Study Details

Brief 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

Conditions

Nuclear Sclerosis of the Lens

Phacoemulsification Cataract Surgery

Cataract Bilateral

Study ID

NCT07468877

Start date

Feb 13, 2026

Status verified date

Mar, 2026

Completion date

Feb 13, 2027

Anticipated

Primary completion date

Feb 13, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

Cataract extraction with phacoemulsification comparing two systems

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

Cataract extraction with phacoemulsification comparing two systems

Second arm: Phacoemulsification using Centurion system with OZil technology

Primary outcome measure

  • Cumulative Dissipated Energy [ Time Frame: Intraoperative ]

Central Contacts and Locations

Central contacts

Orly Shiler

3102291220orlyjr@inorbit.com

Locations

Advanced Vision Care

Recruiting

Los Angeles, California, United States, 90067

Contacts

Orly Shiler

8183919507orlyjr@inorbit.com

Principal Investigator:

Nicole R Fram, M.D.

More Information

Sponsor

Nicole Fram M.D.

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • Phacoemolsification
  • Unity VCS/CS
  • Centurion
  • Nuclear Sclerosis of the lens
  • Cataract

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nicole Fram M.D. on 2026-03-18.