Cumulative Dissipated Energy (CDE) and Total Phacoemulsification Energy (Joules) of Unity VCS/CS With 4D Phaco Compared to Centurion System With OZil
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Advanced Vision Care
RECRUITING
Los Angeles
Contact Information
Primary
Orly Shiler
orlyjr@inorbit.com
3102291220
Time Frame
Start Date: 2026-02-13
Estimated Completion Date: 2027-02-13
Participants
Target number of participants: 30
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Nicole Fram M.D.