Next Generation Cataract and Vitreoretinal Surgery Study

Next Generation Cataract and Vitreoretinal Surgery Study

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.

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.

Key Inclusion Criteria:

• Requires posterior segment surgery in the operating room with or without simultaneous cataract surgery;
• Clear media except for cataract and vitreous hemorrhage;
• In simultaneous cataract and vitreoretinal surgery, eligible to undergo primary hydrophobic acrylic intraocular lens (IOL) implantation into the capsular bag;
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Previous vitrectomy in the operative eye aside from those requiring silicone oil removal;
• Neovascular or uncontrolled glaucoma;
• Planned glaucoma or postoperative surgeries during study aside from silicone oil removal;
• Inadequate pupil dilation (less than 6 millimeters);
• Other protocol-defined exclusion criteria may apply.