NCT06165744

Next Generation Cataract and Vitreoretinal Surgery Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 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 formal user feedback.

Detailed description

Subjects will attend a screening visit (Day -30 to Day 0), a surgery visit (Day 0), and 4 post-surgical visits (Day 1, Week 1, Month 1, Month 3) for an overall individual duration of approximately 4 months. One eye (study eye) will be treated. This study will be conducted in Australia.

Conditions

• Vitreoretinal Disease With or Without Cataracts

Interventions

Type	Name	Description
DEVICE	UNITY Vitreoretinal Cataract System	UNITY Vitreoretinal Cataract System (VCS) with console, remote control, foot controller, UNITY TOTAL PLUS Combined Procedure Pak, and additional devices as needed to complete surgery
PROCEDURE	Posterior segment surgery in the operating room with or without simultaneous cataract surgery	Posterior segment surgery involves removal of the vitreous (i.e., vitrectomy) followed by additional interventions as needed. Cataract surgery involves removal of the crystalline lens (which is often cloudy).

Timeline

• Start date: 2024-02-27
• Primary completion: 2024-05-23
• Completion: 2024-08-19
• First posted: 2023-12-11
• Last updated: 2025-06-25
• Results posted: 2025-06-25

Locations

5 sites across 1 country: Australia

Regulatory

• FDA-regulated device study