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

NCT07468877 | Recruiting FDA Device

• 2 other identifiers: AVC-0081405359
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cumulative Dissipated Energy

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

  Intraoperative

Secondary Outcomes (1)

• Total Ultrasound Time

  Intraoperative

Other Outcomes (6)

• Total Aspiration Time

  Intraoperative

• Central Corneal Thickness

  post op day 1

• Anterior chamber inflammation

  Post op day 1 and Post op day 7

Study Arms (2)

Unity VCS/CS with 4D Phaco Handpiece

ACTIVE COMPARATOR

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

Centurion vision system with OZil Handpiece

ACTIVE COMPARATOR

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

Interventions

Cataract extraction with phacoemulsification comparing two systems DEVICE

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

Unity VCS/CS with 4D Phaco Handpiece

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nicole Fram M.D.: lead

Study Sites (1)

Advanced Vision Care

Los Angeles, California, 90067, United States

RECRUITING

Related Publications (1)

• Erratum: Comparison of cumulative dissipated energy between the Infiniti and Centurion phacoemulsification systems [Corrigendum]. Clin Ophthalmol. 2015 Aug 19;9:1475. doi: 10.2147/OPTH.S93330. eCollection 2015.

  PMID: 26316688 BACKGROUND

MeSH Terms

Conditions

Cataract, Age-Related Nuclear; Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Nicole R Fram, M.D.

  Advanced Vision Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Orly Shiler

CONTACT

3102291220; orlyjr@inorbit.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Contra-lateral eye design

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 13, 2026
• Study Start: February 13, 2026
• Primary Completion (Estimated): February 13, 2027
• Study Completion (Estimated): February 13, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)