NCT07468877

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

Cumulative Dissipated Energy (CDE) and Total Phacoemulsification Energy (Joules) of Unity VCS/CS With 4D Phaco Compared to Centurion System With OZil

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Nicole Fram M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

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

Interventions

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

Timeline

• Start date: 2026-02-13
• Primary completion: 2027-02-13
• Completion: 2027-02-13
• First posted: 2026-03-13
• Last updated: 2026-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study