At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Next Generation Cataract and Vitreoretinal Surgery Study
In Brief
A clinical study evaluating UNITY Vitreoretinal Cataract System and Posterior segment surgery in the operating room with or without simultaneous cataract surgery for Vitreoretinal Disease With or Without Cataracts. Completed, enrolled 120 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Interventions
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
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).