Real-World Study of Vivity Intraocular Lenses (IOLs)

Real-World Study of AcrySof™ IQ Vivity Extended Vision Intraocular Lenses (IOLs)

The primary objective of this clinical study is to assess the clinical performance of the AcrySof IQ Vivity Extended Vision IOL in a Chinese population.

In this clinical study, subjects will be implanted with the AcrySof IQ Vivity Extended Vision 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 13 months. This study will be conducted in China.

Key Inclusion Criteria:

• Able to understand and sign an approved informed consent;
• Willing and able to attend all scheduled study visits as required per protocol;
• Diagnosed with cataracts in both eyes;
• Pre-operative regular corneal astigmatism less than 1.0 diopter (D);
• Planned bilateral cataract removal by phacoemulsification.
• 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 surgery history;
• 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 can only undergo cataract surgery in one eye.
• Other protocol-specified exclusion criteria may apply.