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 — DEVICEFirst arm: Phacoemulsification using UNITY VCS/CS system with UNITY 4D phaco handpiece
- Cataract extraction with phacoemulsification comparing two systems — DEVICESecond 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 HandpiecePatients 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 HandpiecePatients 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
- Orly Shiler3102291220
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Advanced Vision Care | Los Angeles | California | 90067 | Nicole R Fram, M.D. (PRINCIPAL_INVESTIGATOR) |
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