Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population

Post-Market Clinical Study of the AcrySof® IQ PanOptix® Presbyopia Correcting Intraocular Lens in a Chinese Population

The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.

In this clinical study, subjects will be implanted with the PanOptix IOL in both eyes. The second eye surgery will occur 7-28 days after the first eye. A total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. The total expected duration of the subject's participation will be about 14 months. This study will be conducted in China.

Key Inclusion Criteria:

• Able to comprehend and sign an informed consent form;
• Able to complete all study visits required in the protocol;
• Chinese; diagnosed with cataracts in both eyes;
• Planned bilateral cataract removal by routine phacoemulsification;
• Pre-operative regular corneal astigmatism of less than 1.0 diopter (D);
• Pre-operative best corrected distance visual acuity (BCDVA) worse than or equal to 0.3 LogMAR in each eye;
• Potential postoperative best corrected distance visual acuity (BCDVA) of 0.3 logMAR or better in both eyes based on the investigator expert medical opinion.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve;
• Clinically significant corneal diseases;
• Clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion;
• Previous intraocular or corneal surgery;
• Pregnancy or lactation during study or planning to be pregnant/lactating;
• Systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk to the subject;
• Other planned ocular surgical procedures;
• Patients who desire monovision correction.
• Other protocol-specified exclusion criteria may apply.