NCT06071104

Next Generation Cataract Surgery Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to obtain device-specific safety and performance clinical data to support marketability in Europe and to collect user preference data.

Detailed description

Subjects will attend a screening visit (Day -60 to Day 0), a surgery visit (Day 0), and 3 post-surgical visits (Day 1, Week 1, Month 1) for an overall individual duration of up to 3 months. One eye (study eye) will be treated. This study will be conducted in the United States.

Conditions

• Cataract

Interventions

Type	Name	Description
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)
DEVICE	UNITY VCS	UNITY Vitreoretinal Cataract System (VCS) with console, remote control, foot controller, UNITY Cataract FMS Pack, and UNITY Anterior Vitrectomy Kit

Timeline

• Start date: 2023-12-06
• Primary completion: 2024-05-23
• Completion: 2024-06-28
• First posted: 2023-10-06
• Last updated: 2025-06-04
• Results posted: 2025-06-04

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study