Cumulative Dissipated Energy (CDE) and Total Phacoemulsification Energy (Joules) of Unity VCS/CS With 4D Phaco Compared to Centurion System With OZil
Nicole Fram M.D.
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
Description
Unity and Centurion are two phacoemulsification systems routinely used during cataract surgery to assist the surgeon in removing the cataractous lens from the eye. This clinical trial aims to compare the performance of Unity versus Centurion during standard cataract surgery. The primary objective of this study is to explore CDE and Ultrasound time during cataract extraction compared to Centurion. This study will enroll 30 subjects (60 eyes) diagnosed with Nuclear Sclerosis cataract who require cataract surgery with intraocular lens implantation in both eyes.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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, tra…
Interventions
- DeviceCataract extraction with phacoemulsification comparing two systems
First arm: Phacoemulsification using UNITY VCS/CS system with UNITY 4D phaco handpiece
- DeviceCataract extraction with phacoemulsification comparing two systems
Second arm: Phacoemulsification using Centurion system with OZil technology
Location
- Advanced Vision CareLos Angeles, California