NCT07044674

A Cataract Surgery Clinical Trial

Cataract Surgery: Randomized Comparative Clinical Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare the efficiency and safety of UNITY™ Vitreoretinal Cataract System (UNITY VCS) to CENTURION® Vision System with Active Sentry (CAS) in adult subjects with grade 2 or greater nuclear sclerotic cataracts who require phacoemulsification in both eyes. Subjects will attend a total of 8 scheduled visits for an individual duration of participation of approximately 1 month.

Detailed description

In this contralateral eye clinical study, one eye will undergo surgery with UNITY VCS and the other eye will undergo surgery with CAS. The second eye surgery will occur 0 to 14 days after the first eye surgery.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	UNITY Vitreoretinal Cataract System	UNITY VCS is a commercially approved surgical system that facilitates the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during eye surgery. It consists of a console, remote control, foot controller, video overlay, and compatible anterior segment devices. In this study, it will be used for the removal of cataracts.
DEVICE	CENTURION Vision System with Active Sentry	CAS is a commercially approved surgical system for use during anterior segment ophthalmic surgery. It consists of a console, foot controller, remote control, video overlay, and compatible anterior segment devices. The Active Sentry handpiece will be used.
PROCEDURE	Anterior segment ophthalmic surgery	Cataract surgery during which the crystalline lens (often cloudy) is broken into small pieces and gently removed from the eye with suction (phacoemulsification)

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2025-07-01
• Last updated: 2025-12-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study