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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Nicole Fram M.D.
Study ID
NCT07468877
Status
Recruiting

Conditions

  • Cataract Bilateral
  • Nuclear Sclerosis of the Lens
  • Phacoemulsification Cataract Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cataract extraction with phacoemulsification comparing two systems — DEVICE
    First arm: Phacoemulsification using UNITY VCS/CS system with UNITY 4D phaco handpiece
  • Cataract extraction with phacoemulsification comparing two systems — DEVICE
    Second arm: Phacoemulsification using Centurion system with OZil technology

Study Details

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

Key Dates

Start date
Feb 13, 2026
Status verified
Mar 2026
Primary completion
Feb 13, 2027
Completion
Feb 13, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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

Primary Outcome Measure

Cumulative Dissipated Energy [ Time Frame: Intraoperative ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Advanced Vision CareLos AngelesCalifornia90067
Orly Shiler
8183919507
Nicole R Fram, M.D. (PRINCIPAL_INVESTIGATOR)

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