Clinical Investigation of the Clareon® Intraocular Lens (IOL)

Clinical Investigation of the Clareon® IOL

The objective of this study is to compare visual acuity and adverse event outcomes from the Clareon intraocular lens (IOL) to historical safety and performance endpoint (SPE) rates.

Upon meeting eligibility criteria, subjects were implanted unilaterally (in one eye) with a Clareon IOL. Subjects attended 7 study visits over a period of approximately 13 months, including 1 preoperative screening visit (Visit 0), 1 operative visit (Visit 00), and 5 postoperative visits (Visits 1-5). Visit day calculations for Visits 1-5 were based off of the day of surgery (Visit 00). Primary endpoint data was collected at the final visit (Month 12). Some sites/subjects participated in a Rotational Stability sub-study. For the non-study eye, the investigator followed standard of care regarding the follow-up, surgery, and intraocular lens choice (as applicable). The non-study eye (fellow eye) was not implanted with the Clareon IOL.

Key Inclusion Criteria:

• Planned routine cataract surgery in at least one eye;
• Calculated lens power within the available range;
• Willing and able to sign an informed consent statement;
• Clear intraocular media other than cataract.

Key Exclusion Criteria:

• Any disease or pathology, other than cataract, that is expected to reduce the potential postoperative best corrected distance visual acuity (BCDVA) to a level worse than 0.30 logMAR;
• Previous corneal surgery;
• Rubella or traumatic cataract;
• Ocular trauma, previous refractive surgery;
• Current or recent use of certain medications as specified in the protocol;
• Any other ocular or systemic condition that, in the opinion of the Investigator, should exclude the subject from the study.