Next Generation Cataract Surgery Study

Next Generation Cataract 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 user preference data.

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.

Key Inclusion Criteria:

• Able to understand and sign an IRB/IEC approved Informed Consent form.
• Willing and able to attend all scheduled visits as required by the protocol.
• Clinically documented diagnosis of age-related noncomplicated cataract.
• Eligible to undergo primary hydrophobic acrylic intraocular lens implantation into the capsular bag.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Women of childbearing potential as defined in the protocol.
• Planned postoperative procedures during the course of the study in the operative eye.
• Previous intraocular or corneal surgery in the operative eye.
• Diagnosis of glaucoma or ocular hypertension (IOP > 21 mmHg) in the operative eye.
• Other protocol-defined exclusion criteria may apply.