A Cataract Surgery Clinical Trial

Cataract Surgery: Randomized Comparative Clinical Trial

The purpose of the study is to compare the efficiency and safety of UNITY™ Vitreoretinal Cataract System (UNITY VCS) to CENTURION® Vision System with Active Sentry (CAS) in adult subjects with grade 2 or greater nuclear sclerotic cataracts who require phacoemulsification in both eyes. Subjects will attend a total of 8 scheduled visits for an individual duration of participation of approximately 1 month.

In this contralateral eye clinical study, one eye will undergo surgery with UNITY VCS and the other eye will undergo surgery with CAS. The second eye surgery will occur 0 to 14 days after the first eye surgery.

Key Inclusion Criteria:

• Clinically documented diagnosis of age-related nuclear sclerotic cataract of grade 2 or greater in both eyes;
• Both eyes with similar nuclear sclerotic cataract severity and type (within 1 cataract grade);
• Both eyes able to be implanted with same intraocular lens material;
• Both eyes able to receive the same ophthalmic viscosurgical device (OVD).
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Planned intraoperative glaucoma surgery or expected postoperative procedures during the study in either study eye;
• Laser-assisted cataract surgery in either study eye;
• Any ocular disease and/or condition that, in the investigator's clinical judgement, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study.
• Other protocol-specified exclusion criteria may apply.