Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens

Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens

The objective of this study is to evaluate clinical outcomes following sub-2 mm micro-incision cataract surgery (MICS) and intraocular lens (IOL) implantation. This study is evaluated in two Phases

• V4 (6M) endpoint: primary analysis
• V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis

Inclusion Criteria:

• Subjects must have clear intraocular media other than cataract in the study eye.
• Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with micro-incision phacoemulsification cataract extraction in the study eye.

Exclusion Criteria:

• Subjects with ocular malformation in the study eye.
• Subjects who have had previous surgery in the study eye.
• Subjects with uncontrolled glaucoma in either eye.
• Subjects with any anterior segment pathology for which micro-incision phacoemulsification cataract surgery would be contraindicated
• Subjects using medications known to potentially complicate cataract surgery.